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The Cannabis Tech Stack – A Blueprint for Scalable, Audit-Ready Growth

Tue, 20 Jan 2026 20:11:57 GMT

Setting The Table

The cannabis industry has matured over the years; it all started with a wave of enthusiasm and market participants, many running lean, mostly manual operations with bright-eyed talent spanning all sorts of professional backgrounds. Since then, there has been massive consolidation within license holders across North America. A good chunk of the once enthusiastic talent has left and returned to more ‘traditional’ and ‘stable’ sectors like pharma, food & beverage, natural health products, etc. The remaining players in the game are almost certainly in a better financial position than they were say 5 years ago. That said, we are entering a new dawn where operational excellence and margin control will differentiate the truly blue-chip operators from the rest and set the table for truly explosive growth once some much-anticipated regulatory catalysts come to fruition.

Why Cannabis Needs a Purpose-Built Tech Stack

Extremely high regulatory burden with unique jurisdictional requirements (i.e. GMP, GACP, GPP, Health Canada, state regulatory agencies, etc.)
Traceability requirements currently exceed requirements from most other manufacturing verticals
Talent shortage and turnover are huge issues for the sector and tech can not only help automate some gaps, but also help reinforce the processes & policies that contribute to a company’s knowledge base and culture (i.e. quicker onboarding & integration for new hires)
Margin pressure is a constant in a highly-competitive, highly taxed sector like cannabis – tech drives efficiency and risk reduction
Combine the high turnover with the high regulatory burden and you have significant compliance risk; when process knowledge and records live in local folders or on personal devices, they often leave with departing employees. Purpose-built systems centralize information for long-term knowledge retention and help ensure continuity and reliable task completion as personnel change

The Tech Stack (4 Layers)

1st Layer = Foundational Layer: Compliance & Quality - this layer ensures you ‘pass the audit’ – not just run the operation.

A QMS serves as the governance layer that defines SOPs, validation, training, and record retention across every technology in the stack, strengthening control during implementation and ensuring consistent, compliant operation after.

eQMS (electronic Quality Management System) – includes Document Control & Training Mgmt. as well as management of CAPAs, Deviations, Complaints, Change Controls, Audits, Suppliers etc.

2nd Layer = Operational Execution Layer – this layer ensures you execute batch runs smoothly and efficiently

Cultivation / Manufacturing / Inventory Software (i.e. seed-to-sale platforms) – grow room data tracking, inventory, production and labour tracking, batch records as well as METRC/CRA/State Reporting support
IoT / Sensors – temperature & humidity monitoring, lighting controls, predictive and reactive maintenance alerts
CMMS (Computerized Maintenance Management System) - integrated maintenance management for all equipment/assets across the operation*

*Note: some eQMS platforms come with built-in CMMS functionality out of the box, like C15 Solutions

3rd Layer = Financial + Enterprise Systems – this layer ensures dollars and people are accounted for and looked after

ERP / Accounting Software – tracks market value of inventory, chart of accounts, AP/AR, purchasing, cost allocation/COGS etc. Some S2S/MES platforms may have this functionality but most do not.
HR Software / Payroll – time tracking, onboarding workflows (may be integrated with eQMS), safety & training alignment w/ QMS, overtime cost control

4th Layer = Commercial & Brand Enablement Systems

CRM / Pipeline Mgmt. – dispensary relationship management, wholesale sales planning, pricing & promotion management
E-Commerce / Marketplace Integrations – B2B ordering portals, provincial boards/distributor API support

Bringing it all Together

One of the big benefits of using technology, above and beyond the benefits touched on above, is that it often results in the standardization of your data. Put simply, standardization of data leads to better reporting which leads to better analysis which leads to better business decisions.

Step 1 is to implement the stack.
Step 2 is to refine/customize processes and workflows across the tech stack so it meets your unique business requirements.
Step 3 is to integrate relevant tech with one another such as integrating your eQMS with your S2S or ERP – this ultimately creates a single source of truth (less data errors/discrepancies), and reduces time to market by enabling production and quality to work seamlessly together.
Step 4 , which is totally optional at this point but may represent a competitive advantage, is applying artificial intelligence (“AI”) to your systems to execute robust data analysis and deliver operational insights.

Exporting to Japan – A Highly Regulated Medical Market

Wed, 22 Oct 2025 14:55:05 GMT

Japan has one of the world’s oldest demographics and is ranked as the 4th largest GDP with no domestic production of cannabis products. On the surface this makes Japan a hugely attractive export market.

Japan is a relatively new cannabis market, having amended its Cannabis Control Act in December 2024. One material result was to remove the blanket ban on cannabis-derived pharmaceuticals. The focus has changed to medical use of cannabis with an ultra low THC limit for these medical products – 0.001% THC to be specific.

This creates a high bar for the cannabis manufactures that wish to service this market. The sector size is estimated to be anywhere between $115M - $145M with high growth forecasts of 28-30% CAGR (‘compound annual growth rate’) into 2030-2033 ( https://www.grandviewresearch.com/horizon/outlook/cannabidiol-market/japan ). Once those restrictions begin to ease, expect the growth rate and total addressable market to increase substantially.

The upsides are obvious; Canadian exporters are not subject to (rather crippling) cannabis excise tax duty, immediately improving the economics vs. domestic sales. For US exporters, emerging APAC demand for compliant bulk ingredients and finished goods rewards the few suppliers who can consistently hit spec and prove it. One of the biggest challenges for exporters now, is of course meeting those strict THC thresholds.

Unfortunately, because of the size of the shipments and potential for revenue loss if those thresholds aren’t met, there have been many cases of COA (‘certificate of analysis’) manipulation. Further to that, paper and email simply is not scalable – when permits, specifications, invoices and batch records all move through inboxes, you lose traceability, auditability and version control. Culturally, Japan places a very high value on partners who embrace a quality culture.

People + Process + Technology

This is where TrueImports and C15 Solutions come into play. TrueImports, led by Mary Szomjassy Brown and Robert Gregg, is an international certification and importation company that serves as a broker for aspiring exporters. The company has established a closed-loop system to ensure scalable, auditable, cannabinoid importation into Japan using C15 Solutions digital eQMS.

TrueImports manages a C15 Solutions eQMS environment whereby all relevant exporter documentation and test results are uploaded into C15’s 21 CFR Part 11, EU Annex 11 and ERES (Japan equivalent) compliant ‘Vault’ with audit trails. C15 ‘Vault’ provides shared access to both the exporting producer and the Japanese Ministry of Health (JMH). TrueImports also works with multiple, designated labs recognized by Japan authorities that execute official testing for all cannabinoid exports into Japan.

The exporting producer will upload specs, permits, batch records, COAs, and any other forms related to shipment into the C15 Vault for review by the international TrueImports team. Once reviewed, the JMH will then access the C15 Vault and approve the export for shipment. Tracking and any correction of issues is executed under an audit trail with full traceability across multiple versions of documents. The C15 Vault acts as a complete data repository, where all partner and client data is grouped into version controlled digital binders that are stored in perpetuity.

Role based access ensures exporting partners only see what they are authorized to.

In this scenario, TrueImports (the people) have created a closed-loop framework (the process) leveraging C15’s eQMS (the technology) to create a digital compliance bridge that ensure supply chain integrity for the Japanese medical market.

Health Canada Mandates GMP for NHPs by March 2026

Thu, 16 Oct 2025 20:56:39 GMT

First off, here is a direct link to Health Canada’s website outlining the upcoming regulation changes for the Natural Health Product sector - https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/guidance-documents/guide-natural-health-products-0158.html .

What Changed

Clearer, end-to-end quality system expectations. Stronger emphasis on a documented QMS (‘Quality Management System’) - quality manual, roles, self-inspection, management engagement, and on the QAP’s explicit approval responsibilities.
Role-by-activity mapping. Clarifies which GMP sections apply to manufacturers, packagers, labellers, importers, distributors, and storers (e.g., specs, premises, equipment, QA, records). Depending on your business, the rules are different.
Testing modernization.
Confirmatory testing encouraged for added assurance (esp. new or higher-risk suppliers).
Reduced/rotational testing allowed with strict prerequisites (e.g., water activity, historical data, statistical confidence, ongoing controls) and clear OOS escalation rules.
Composite testing generally not acceptable for finished products (risk of masking contaminants).
Quantification by input permitted when controls and documentation meet defined criteria.
Importer accountability upgraded. Ability to leverage MRA/PIC/S evidence (e.g., batch certificates) with continued Canadian release responsibility and periodic batch record oversight.
Premises & utilities detail. Practical requirements for zoning, pest control, environmental monitoring, water quality , and documented storage conditions (including daily records).
Equipment & personnel. Explicit expectations for fit-for-purpose equipment , cleaning/calibration logs, and training matrices with periodic GMP refreshers and effectiveness checks.
Risk/CAPA appendices. Risk classification for observations and a structured CAPA process to standardize remediation.

Why This Matters

There is a firm deadline. By Mar 4, 2026, regulated parties must be able to provide evidence of compliance. Health Canada inspections will expect records, not intentions.
Reduced testing = reduced risk only if controlled. The guide lets you cut cost/time without cutting assurance, but only with robust data (side note, it’s MUCH easier to collect and demonstrate data using an electronic QMS), supplier qualification, and QAP governance.
Importing gets stricter. Leveraging foreign GMP is helpful, yet you remain responsible for Canadian release, label alignment, and periodic verification.
Data integrity moves center stage. Daily environment logs, water results, calibration, training, CAPA, and batch review must be consistent, retrievable, and audit-ready . When it comes to data integrity, following the ALCOA++ framework is mandatory.

ALCOA++

The full acronym ALCOA++ expands on the original ALCOA principles by adding completeness, consistency, enduring quality, and availability, as well as the most recent addition: traceability.

Attributable : Data should be traceable to the person or system that generated it.
Legible : Data must be in a readable and understandable form to allow for review.
Contemporaneous : Data should be captured at the time the observation or activity occurs.
Original : The data should be the first-hand capture of the observation, or a certified true copy.
Accurate : The data must exactly reflect what was observed and recorded, with any changes or errors clearly documented.
Complete : All data, including tests, reanalyses, and any missing information, should be recorded.
Consistent : Data should be documented in a logical, orderly, and chronological sequence.
Enduring : Records must be maintained in a permanent or semi-permanent form for the specified regulatory duration.
Available : Data must be accessible for review, audits, and inspections throughout its entire lifecycle.
Traceable : There should be a complete audit trail showing who changed what, when, and why.

C15 eQMS Can Help

C15 eQMS gives you the controls, traceability, and evidence this guide expects, straight out of the box:

Specifications control & QAP release (complete with 21 CFR Part 11 compliant signatures that fully adhere to ALCOA++ principles) : versioned specs, change control, e-signatures, and a QAP dashboard for documented approvals and release decisions
Testing strategy governance: workflows to design/justify reduced or rotational testing; automated COA analysis (to aggregate your test result data and do trend analysis), OOS handling, and seamless integration into digital batch records
Importer toolkit: supplier qualification, COA ingestion, periodic batch record review reminders, and label control checks
Equipment & training: calibration/Preventative Maintenance schedules, usage/cleaning logs, training matrices (full role-based curriculum training available) with read-and-understand and effectiveness checks, deviation handling
CAPA & risk: built-in risk assessment for quality events and guided CAPA workflows aligned to the guide’s appendix.
EXPERIENCE: C15 currently has 15+ customers operating in GMP production environments and our team of Customer Success Managers have a track record of success when it comes to assisting with audit preparation and validation of systems (another GMP requirement).

Ready to hit GMP by March 2026?

Speak with our experts and book a quick walkthrough of the C15 eQMS platform and become audit-proof for 2026.

Cannabis Exports and the Role of Quality

Fri, 12 Sep 2025 17:35:43 GMT

As global cannabis trade accelerates, quality assurance (QA) and GMP/GACP-aligned systems aren’t optional, they’re the backbone of export success.

Canada Leads Today But What Happens When the U.S. Joins?

Canada remains the dominant exporter into key medical markets like the UK, Israel, Portugal and Germany. In Q2-2025, Germany imported 43,257 kg of medical cannabis, nearly half (20,107 kg) coming from Canada - up from 16,057 kg in Q1. Portugal was second at 13,465 kg .

What could unlock U.S. exports.

The U.S. is moving toward a federal shift (e.g., rescheduling to Schedule III has been formally proposed and is under rulemaking), which, while not full legalization, signals a break from the Schedule I status quo and opens the door to a more normalized federal framework over time.

To be clear, there are medical-only, CBD-only markets that are very much accessible by US operators, assuming their finished products meets the importing jurisdictions’ THC thresholds, which in some cases – like Japan for instance – is as low as 0.001% THC, significantly lower than the US federal hemp threshold of 0.03% THC. That said, eventual federal reform could unlock significantly larger export opportunities for US operators.

What Canadian and American Operators Can do to Prepare to Export

1. Design for treaty-grade exports.

Build a documentation package that satisfies Single Convention shipment-by-shipment controls: import permit match, export authorization, batch reconciliation, destruction logs for variances. UNODC

2. Pursue EU-GMP alignment ahead of the turn.

Gap-assess state-level GMP vs EU-GMP (Annex 11, data integrity) and FDA expectations for records. Validate electronic systems, signatures, and audit trails now—don’t wait for the rush. U.S. Food and Drug Administration

3. Pilot with import-friendly markets.

Map requirements for Germany/UK/Israel and assemble a “golden dossier” (MBR/EBR, CoAs, stability, change control history, GDP logistics). Use Canada’s current flow into Germany as your template for volume planning and documentation structure.

4. Build a digital export ‘compliance bridge’

Centralize: SOPs, deviations/CAPAs, supplier qualifications, transport validation, and permit chains in a 21 CFR Part 11 / Annex 11–validated eQMS so each export file can be generated and audited instantly. Adhering to ALCOA++ principles (strict data integrity framework) is essential to demonstrate full proof of compliance and trust.

Spotlight: Digital Compliance Bridge to Japan

C15 has implemented, with a Japanese partner a secure digital compliance bridge to Japan’s medical market. By integrating batch records, permits, and certificates of analysis into a closed, validated environment, the platform has given the Japanese Ministry of Health a single source of truth to review all inbound product data to facilitate the certification. The entire process is the process aligned with GMP, 21 CFR Part 11 and EU Annex 11 expectations and the technology enforces ALCOA++ data integrity principles so the Ministry of Health know that has been no manipulation to batch records or test results. This system enabled real-time regulatory submission, replacing error-prone, slow manual workflows and notifications.

Importers in target export jurisdictions already have some elements of this compliance bridge, however, often it is paper based evidence demanded. Time consuming procurement forms and re-testing [products] due to lack of trust.

Conclusion: Trust and Growth Demand Digital Quality

Global cannabis export/import is built on trust: regulators, patients, and partners need assurance that products are safe, consistent, and compliant. A digital QMS grounded in GMP and QA best practices delivers:

Regulatory alignment across markets (EU, UK, Israel, Asia)
Operational excellence through traceable, auditable data
Competitive advantage through export-readiness and speed

Quality isn’t just regulatory hygiene, it’s a strategic advantage. With a solid digital QMS, companies don’t just meet markets they build trust and unlock global opportunities.

Budgeting for eQMS: How QA Professionals Can Make the Case for Approval

Thu, 14 Aug 2025 15:33:48 GMT

For many QA leaders, the toughest part of getting a digital Quality Management System (‘eQMS’) approved isn’t evaluating the software, it’s justifying the investment to decision-makers who don’t live in the world of audits, deviations, and CAPAs.

Unfortunately, many decision-makers often regard QA professionals as cost centers rather than the builders and protectors of brand equity that they are.

The overarching key to successfully articulating QA’s value? Stop framing eQMS as a tool that only helps QA do its job. Instead, show how it solves problems across the entire organization .

1. Make it About the Business, Not Just Compliance

Executives think in terms of risk, efficiency, and growth. While regulatory readiness is critical, your pitch should connect eQMS to:

Faster product release cycles (shorter approval times, less deviations, faster product to market)
Lower risk of costly product recalls (and the subsequent brand damage)
Smoother market expansion into regulated jurisdictions (leverage tech to standardize processes across newly acquired assets while adhering to state-specific regulations)
Product Liability Risk and Insurance costs (the latter of which will decrease as an enterprise’s TCOR (‘total cost of risk’) does down

Ultimately, it all comes down to Return On Investment . When leadership sees that eQMS is about protecting revenue and enabling growth, not just checking QA boxes, budget conversations shift.

2. Show the Power of Tech Stack Consolidation

Many organizations run separate systems for:

EHS (Environmental, Health & Safety)
CMMS (Maintenance Management)
LMS (Training)
Document control (Content Management)
PLM (Product Lifecycle Management)

A robust, enterprise eQMS can bring all of these under one platform. That means:

Fewer vendors to manage
Lower subscription and support costs
Unified reporting and analytics
One source of truth for quality, safety, training, and maintenance records

This isn’t just a software purchase, it’s tech stack optimization .

3. Link It to the Cost of Quality

Typically, the C-suite only ‘see’ the COGS (Cost of Goods Sold), while having a complete blind spot when it comes to the cost of quality. Poor quality costs money in rework, scrap, downtime, lost sales, and regulatory penalties.

A digital QMS:

Reduces deviations through real-time monitoring and controlled workflows
Prevents repeat issues with faster, more effective CAPA closure
Minimizes downtime with integrated maintenance and training records
Curries good favor with Regulatory Authorities with complete visibility and trust

Lowering the Cost of Poor Quality (CoPQ) directly improves margins, making eQMS a profit protection tool.

4. Build the Business Case with Numbers

If possible, quantify:

% reduction in manual admin time for QA staff
Average hours saved per audit preparation
Projected savings from vendor consolidation
Estimated CoPQ reduction from better process control

When leadership sees ROI on paper, budget approval becomes far easier.

Bottom Line

An eQMS isn’t “just another QA tool” - it’s a strategic enterprise system that:

Consolidates systems
Lowers operational costs
Protects the brand
Enables growth in regulated markets

When you frame it this way, budgeting becomes less about cost (control) and more about return .

C15 Solutions and GxP Solutions Announce Strategic Partnership to Simplify Regulatory Compliance

Mon, 14 Jul 2025 14:08:24 GMT

Toronto, ON [7/14/2025] C15 Solutions , a leader in digital Quality Management Systems (eQMS), and GxP Solutions , a trusted provider of GxP compliance consulting and recruiting services for the regulated manufacturers in the cannabis, natural health product, pharma and food sectors, are proud to announce a collaboration partnership.

This collaboration combines C15’s validated, cloud-based QMS platform with GxP Solutions’ deep regulatory and operational expertise; C15’s eQMS technology will enable GxP Solutions to more effectively work with mutual clients as well as streamline their quality and compliance processes.

“This partnership is about more than software or consulting, it’s about simplifying compliance for companies that operate under some of the most demanding quality and regulatory standards in the world and delivering trusted expertise through cutting edge technology,” said Sean Samuel, VP Sales for C15 Solutions.

“We’re excited to pair our hands-on GxP knowledge with a technology platform that enables real-time oversight, audit readiness, and operational efficiency,” said Mandy Wagner, CEO & Founder of GxP Solutions.

What It Means for Clients

Together, C15 and GxP Solutions will deliver joint service offerings that reduce implementation time, time to market (for new entrants), accelerate regulatory readiness, and help quality teams shift from reactive to proactive, data-based operations. From licensing and validation support to digital transformation of core quality processes, the partnership ensures that clients get both the strategic guidance, and the digital infrastructure needed to thrive in complex regulated markets. Further details on bundled solutions and joint programs will be announced in the coming weeks.

About C15 Solutions

C15 Solutions delivers a cloud-based, GMP-ready eQMS platform purpose-built for regulated industries. With clients across North America, UK, Europe, Australia and Portugal, C15 transforms enterprise quality.

About GxP Solutions

GxP Solutions is a Canadian compliance consultancy helping local and global life science and pharmaceutical companies confidently navigate Canadian, U.S., European and Indian GxP regulatory requirements. Our expert team provides end-to-end support across the Quality Management System—including licensing, audits, inspection readiness, process development, training, and operations. We also offer strategic recruiting services tailored to the pharma and life science sectors. With GxP Solutions, experience matters—because it takes one to know one.

For media inquiries or partnership opportunities, please contact:

Sean Samuel – VP Sales & Marketing

sean.samuel@c15solutions.com

Mandy Wagner, PMP – CEO/Founder

mandy@gxpsolutions.ca

www.c15solutions.com | www.gxpsolutions.ca

Why QMS Software Is No Longer Optional in Regulated Industries

Thu, 10 Jul 2025 16:23:47 GMT

Many companies are still clinging to paper-based and unconnected electronic processes, despite the clear disadvantages. Without modern tools like QMS software, these organizations risk compromising product quality, falling behind in compliance, and ultimately losing competitive ground.

In contrast, forward-thinking companies are accelerating their technology adoption. According to Gartner, global IT spending is projected to hit $5.74 trillion in 2025—a 9.3% increase from 2024. Much of this investment is funneled into core business applications such as cloud platforms, cybersecurity, and enterprise systems—includin g QMS software designed to modernize and streamline quality management.

Read full article by Stephanie Ojeda

Report: Global Cannabis Regulatory Summit 2025 Summary

Tue, 29 Apr 2025 16:21:59 GMT

At the inaugural Global Cannabis Regulatory Summit in Washington, D.C., leaders from 17 countries gathered to tackle the challenges facing the cannabis industry. Central topics included the urgent need for global standardization, clearer distinctions between medical and adult-use markets, the industry's responsibility to lead with science, and the widespread educational gaps across healthcare, regulatory, and consumer sectors. The event emphasized collaboration between standards organizations and industry stakeholders to build a more harmonized and trusted global cannabis framework.

Read full article by David Vaillencourt.

QMS in Massachusetts: A Compliance Essential for Cultivators and Manufacturers

Wed, 26 Mar 2025 03:47:09 GMT

Massachusetts cannabis cultivators and product manufacturers are required to implement a Quality Management System (QMS) to comply with state regulations and ensure product safety, consistency, and accountability. Under 935 CMR 500.105 and 935 CMR 500.120 , the Cannabis Control Commission (CCC) outlines strict operational requirements, including written procedures, quality controls, and recordkeeping protocols.

For cultivators and manufacturers, a robust QMS isn’t just about staying compliant—it’s the backbone of sustainable, high-performing operations.

Key Aspects of QMS Implementation for Cultivators and Manufacturers

1. Standard Operating Procedures (SOPs)

Per 935 CMR 500.105(1), licensees must develop and maintain SOPs that govern cultivation, production, sanitation, waste disposal, security, and packaging. For example:

Cultivators need SOPs for pest management , nutrient schedules , batch tracking , and environmental controls .
Manufacturers must document procedures for extraction , infusion , post-processing , and cleanroom operations .

These SOPs are central to your QMS and serve as the foundation for consistent, compliant operations.

2. Product Testing and Quality Assurance

Under 935 CMR 500.160, all marijuana and marijuana products must be tested by Independent Testing Laboratories (ITLs) before sale. Your QMS should ensure:

Documentation of batch samples, chain of custody, and lab reports.
Quality hold procedures for quarantining untested or failed product batches.
Review protocols for assessing lab results and determining corrective actions.

3. Corrective and Preventive Actions (CAPAs)

Non-conformances, whether related to equipment, processes, or test failures, require documented responses under your QMS. According to 935 CMR 500.105(1)(l), you must maintain a process for handling complaints and adverse events, which often tie directly into your CAPA program. A good CAPA workflow includes:

Root cause analysis.
Assignment of responsibility.
Timelines for resolution.
Documentation of resolution and effectiveness verification.

4. Employee Training and Competency

Under 935 CMR 500.105(1)(m), all personnel must be trained in their respective job functions, including sanitation, safe handling, and emergency procedures. Your QMS should manage:

Training schedules and content.
Role-based competency checklists.
Electronic records of training completion and recertification dates.

5. Audit Readiness and Internal Reviews

To stay inspection-ready, your QMS should include periodic internal audits and quality reviews. While not explicitly required in regulation, internal auditing supports compliance with 935 CMR 500.105 by identifying potential gaps before a CCC inspection occurs.

Why Cultivators and Manufacturers Need a QMS

✅ Regulatory Compliance

With the CCC increasing oversight and license renewals now tied to operational reviews, a well-documented QMS ensures you meet 935 CMR 500.105, 500.120, and 500.160 requirements.

✅ Product Safety and Consistency

From crop to concentrate, maintaining batch traceability, test result integrity, and label accuracy is key to delivering reliable, compliant products to consumers.

✅ Operational Efficiency

Standardized workflows, automated documentation, and streamlined training reduce downtime, minimize rework, and support scale.

✅ Risk Mitigation

A QMS provides visibility into recall protocols, deviation logs, and incident trends, helping your team prevent future issues before they impact compliance or product quality.

Staying Competitive in Massachusetts' Evolving Cannabis Market

With over $5 billion in sales and increasing competition, Massachusetts cultivators and manufacturers must go beyond regulatory minimums. Implementing a digital QMS not only satisfies CCC expectations—it helps you:

Scale production while maintaining quality
Prepare for multi-state expansion with audit-ready documentation
Support branding with verified product consistency and safety

Whether you’re managing a canopy or a kitchen, building your business on a QMS framework is one of the smartest investments you can make. Want to explore how a QMS purpose-built for cannabis operators can support your team in Massachusetts? Ask us for a demo.

QMS in Missouri

Mon, 24 Feb 2025 17:12:10 GMT

In Missouri, the implementation of a Quality Management System (QMS) is a critical requirement for cannabis production facilities, as outlined in the state's regulations. The purpose of a QMS is to ensure that facilities maintain high standards of quality and compliance throughout their operations. Below, we will provide a detailed overview of the QMS requirements, including the regulatory framework, implementation guidelines, and practical implications for licensees.

Regulatory Framework

The requirement for a QMS is specified in 19 CSR 100-1.100(4)(D), which mandates that all licensees implement a QMS using a published standard within one year of receiving department approval to operate. The chosen standard must be applicable to the facility type and emphasize regulatory compliance. Acceptable standards include those offered by recognized organizations such as the International Organization for Standardization (ISO), ASTM International, Cannabis Safety and Quality, or the Foundation of Cannabis Unified Standards.

Implementation Guidelines

Selection of a Standard: Licensees must select a QMS standard that aligns with their specific operations. For example, ISO 9001 is a widely recognized standard that focuses on quality management principles, including customer focus, leadership, and continual improvement.
Documentation and Procedures : The QMS must include comprehensive documentation of all processes and procedures. This includes standard operating procedures (SOPs) for cultivation, manufacturing, and distribution, as well as protocols for handling non-conformities and corrective actions.
Training and Competency : Employees must be trained on the QMS and demonstrate competency in their roles. This ensures that all staff members understand the quality standards and their responsibilities in maintaining compliance.
Monitoring and Measurement : Facilities must establish systems for monitoring and measuring key performance indicators related to quality. This includes regular audits, inspections, and testing to ensure that products meet safety and quality standards.
Continuous Improvement : A core component of the QMS is the commitment to continuous improvement. Facilities must regularly review their processes and make necessary adjustments to enhance quality and efficiency.

Practical Implications for Licensees

Regulatory Compliance: Implementing a QMS helps ensure compliance with Missouri's cannabis regulations, reducing the risk of violations and penalties. It also prepares facilities for inspections and audits by regulatory bodies.
Product Quality and Safety : A robust QMS enhances product quality and safety, which is crucial for consumer trust and market competitiveness. It ensures that products are free from contaminants and meet all labeling and packaging requirements.
Operational Efficiency : By standardizing processes and procedures, a QMS can improve operational efficiency, reduce waste, and lower production costs. This can lead to increased profitability and sustainability for the business.
Risk Management : A QMS provides a framework for identifying and mitigating risks associated with cannabis production. This includes risks related to product recalls, supply chain disruptions, and regulatory changes.

Scenario-Based Example

Consider a cultivation facility that has recently received its license to operate. To comply with the QMS requirement, the facility selects ISO 9001 as its standard. The facility then develops SOPs for each stage of the cultivation process, from seed selection to harvest. Employees undergo training to understand these procedures and their role in maintaining quality. The facility also implements a system for regular testing of soil and water quality, as well as environmental conditions such as temperature and humidity. By continuously monitoring these factors, the facility can quickly identify and address any issues that may affect product quality.

Summary

In summary, the implementation of a Quality Management System is a mandatory requirement for cannabis production facilities in Missouri. It involves selecting an appropriate standard, documenting processes, training employees, and continuously monitoring and improving operations. A well-implemented QMS not only ensures regulatory compliance but also enhances product quality, operational efficiency, and risk management. As regulations evolve, facilities must remain adaptable and committed to maintaining high standards of quality and compliance.

Navigating the Cannabinoid Safety and Regulation Act (CSRA): A Call to Action for Industry Standards

Tue, 15 Oct 2024 18:30:25 GMT

Originally posted by David Vaillencourt, CEO, The GMP Collective

September marked a pivotal moment for the cannabis and hemp industries. Senator Ron Wyden introduced the Cannabinoid Safety and Regulation Act (CSRA), reinforcing the industry’s move toward federally mandated safety standards. Simultaneously, the National Academies of Sciences, Engineering, and Medicine (NASEM) released a comprehensive report emphasizing the urgent need for standardized practices .

The message is clear: compliance with Good Manufacturing Practices (GMPs) and ASTM International standards is no longer a nice to have—it is the bare minimum to ensure product credibility and safety.

The CSRA: Reinforcing the Path Forward

While the CSRA doesn’t establish new precedents, it significantly reinforces what industry advocates and previous legislative efforts have been emphasizing: the necessity for standardized safety and quality practices in cannabinoid products. This alignment with global regulatory practices brings the cannabis and hemp industries in line with how other consumer products are regulated worldwide—through adherence to GMPs.

Key highlights of the bill include:

Mandatory GMP Compliance : All products must be manufactured in facilities adhering to GMP standards, ensuring consistency and safety.
ASTM Standard Symbol Requirement : Products containing intoxicating cannabinoids must display the ASTM standard symbol , promoting transparency and uniformity .
Facility Registration and Inspection : Enhanced oversight through mandatory facility registration and regular FDA inspections.
Comprehensive Labeling : Strict labeling requirements to provide accurate consumer information.

Emphasizing Standards in the NASEM Report

In tandem with legislative developments, the NASEM report titled “Cannabis Policy: Public Health and Health Equity” underscores the critical need for standardized practices. The report calls for increased education, research, and the adoption of established standards to ensure product safety and efficacy.

The report calls for adoption of monographs (a type of standard) published by the U.S. Pharmacopeia (USP), who works closely with ASTM’s Cannabis Committee on developing model standards for the industry. As the Vice-Chair of the ASTM D37 Committee on Cannabis , I’ve witnessed firsthand the dedication to creating robust standards that address both quality and safety across all aspects of cannabis and hemp products.

“Many C15 customers understand that integrating GMP and ASTM standards into their quality programs today is not only essential for compliance but also key to long-term growth and success,” says Sean Samuel of C15 Solutions , an eQMS solution provider for the cannabis industry. “By acting now, they are ensuring a smoother transition into federal oversight while building a competitive advantage. Commercial benefits include unlocking new market opportunities, such as expansion into Europe, attracting new investment, and future-proofing their businesses in a rapidly evolving industry. It’s worth noting that most consumer packaged goods, dietary supplement, and pharmaceutical manufacturers also adhere to GMP and ASTM standards, which means adherence to these standards inherently makes a cannabis operation a more attractive partnership or acquisition target.”

The Writing Is on the Wall

With over a dozen states already integrating ASTM standards into their cannabis regulations, federal legislation like the CSRA underscores the inevitability of nationwide adoption. This alignment not only standardizes practices but also brings the industry in line with global consumer product regulations.

The potential rescheduling of cannabis by the Drug Enforcement Administration (DEA) adds further urgency. Rescheduling would bring cannabis closer to mainstream regulations for consumer products, making compliance with GMPs and ASTM standards essential.

A Call to Action for Operators

For cannabis and hemp companies, the time to act is now. Implementing GMPs and ASTM standards is no longer a strategic advantage—it’s a necessity for survival in a rapidly evolving market. This applies across the board:

Cultivation : Standardized growing practices to ensure consistency and purity.

Laboratory Testing : Rigorous protocols to validate product safety and potency.

Manufacturing : Adherence to GMPs to maintain quality throughout the production process.

Packaging and Labeling : Compliance with new labeling requirements to meet consumer transparency demands.

Expert Support Is Available

At The GMP Collective, we specialize in guiding companies through the complexities of adopting these standards. Our expertise ensures that your products, processes, and facilities are not only compliant but positioned for long-term success in a regulated market.

Complaint Management 101

Wed, 02 Oct 2024 20:04:27 GMT

The Prevalence of Consumer Complaints in the Cannabis Industry
The legal cannabis market is experiencing rapid growth, particularly in North America. As of August 2024, 25 U.S. states have legalized cannabis for recreational use, and many others allow cannabis for medical purposes. Similarly, Canada's legal market continues to grow since the 2018 legalization. However, as more consumers turn to legal cannabis products, the volume of consumer complaints has risen in tandem.

Several factors contribute to this increase in complaints. As cannabis products become more accessible, consumers have higher expectations for product quality, consistency, and safety. Furthermore, the legalization of cannabis has brought in a wider range of consumers, many of whom are less familiar with the potential risks and variability of cannabis products, leading to heightened concerns when products do not meet their expectations.

Common Complaints in Legal Cannabis Products
Consumer complaints in the legal cannabis market cover a broad spectrum, but some of the most frequent issues include:

Product quality concerns : Consumers often complain about the perceived or actual quality of cannabis products. This includes issues like mold, contamination with pesticides, and inconsistency in potency levels.
Labeling inaccuracies: Mislabeled products, particularly in terms of THC and CBD content, are a common source of complaints. Consumers are rightfully concerned when the product they purchase does not match the advertised potency or ingredients.
Packaging issues: Complaints about cannabis packaging are also common, with some consumers finding the packaging difficult to open, while others raise concerns about its environmental impact.
Adverse effects: Unexpected side effects from cannabis products can lead to consumer complaints, especially when the products do not provide adequate warnings or instructions for use.
Customer service grievances: Slow response times, poor handling of product returns, or inadequate customer service can also lead to negative consumer experiences.

A Case in Point: California’s DCC and Pesticide-Laden Cannabis Products
A particularly significant example of the prevalence of consumer complaints in the cannabis industry occurred in California, one of the largest and most heavily regulated cannabis markets in the world. In 2020, the California Department of Cannabis Control (DCC) received a wave of complaints from consumers about cannabis products that were allegedly contaminated with pesticides.

These complaints prompted an investigation by the DCC, which ultimately led to the discovery that several cannabis producers were using illegal pesticides in their cultivation processes. The investigation revealed that multiple batches of contaminated cannabis products had reached the market, putting consumers at risk of exposure to harmful chemicals.

In response to these complaints and the subsequent investigation, the DCC enforced strict penalties on the non-compliant businesses, including product recalls and fines. This case highlights the significant role that consumer complaints can play in uncovering non-compliant practices within the cannabis industry and driving regulatory enforcement.

The Impact of Consumer Complaints on Cannabis Operators
The rise in consumer complaints poses several risks for cannabis operators, particularly in a highly regulated industry like cannabis. The impact of these complaints can be wide-ranging, affecting everything from a company's reputation to its bottom line.

Reputational Damage
In today’s digital age, consumers have more avenues than ever to share their experiences and voice their concerns. Social media platforms, cannabis review sites, and online forums are filled with consumer feedback, both positive and negative. Reddit, for example, seems to be a popular forum for cannabis product feedback. When complaints about product quality or safety arise, they can quickly spread across these platforms, damaging a brand's reputation.

For cannabis operators, negative reviews can have long-lasting effects on customer loyalty. Consumers are likely to steer clear of brands that have been associated with safety issues, poor quality, or negative experiences. In an industry as competitive as cannabis, where brand differentiation is key to success, maintaining a positive reputation is crucial.

Cannabis is still a relatively nascent industry and as such many brands haven’t yet built a foundation of credibility quite yet, which means that a) product complaints can really set you on the back foot without brand equity to fall back on but it also means b) there is an opportunity to build consumer loyalty from your response to complaints . Easier said than done, we will explore this in more detail shortly.

Regulatory Implications
Cannabis operators are subject to stringent regulations, and failing to address consumer complaints can lead to serious regulatory consequences. In the United States, for example, the Food and Drug Administration (FDA) has issued warnings to several companies selling cannabis-derived products (particularly CBD products) due to consumer complaints about mislabeling or false claims about product benefits.

In cases where complaints reveal violations of regulatory standards, cannabis operators may face penalties such as fines, product recalls, or even the suspension of their licenses. The DCC example mentioned earlier demonstrates the regulatory risks operators face when they fail to address quality issues brought to light by consumer complaints.

Financial Losses
Consumer complaints can also have a direct impact on a company’s finances. Negative experiences can lead to lost sales, as dissatisfied customers choose not to make repeat purchases. In addition, when complaints result in product recalls or regulatory penalties, the financial costs can be substantial. Companies may need to halt production, issue refunds, or invest in corrective actions, all of which can strain their resources.

The Formula for Handling Complaints: Compliance x Speed x Resolution x Reporting = Success

The Importance of an Expedited Complaint Response Process
Given the potential consequences of consumer complaints, it is essential for cannabis operators to respond quickly and effectively. A slow or inadequate response can exacerbate the problem, turning a small issue into a larger one.

Building Customer Trust and Loyalty
One of the most important reasons for addressing complaints quickly is the impact it can have on customer trust and loyalty. When consumers feel that their concerns are being taken seriously and that the company is committed to resolving the issue, they are more likely to continue purchasing from that brand. In contrast, a slow or dismissive response can drive customers away, leading to lost business and negative word of mouth.

Mitigating Legal and Regulatory Risks
For cannabis operators, speed is not just about customer satisfaction—it’s also about compliance. Regulatory bodies like the FDA, Health Canada, and the DCC require companies to respond to complaints in a timely manner. Failing to do so can lead to investigations, fines, and other penalties. By establishing a robust complaint response process, operators can reduce the risk of regulatory action and ensure they remain compliant with industry standards.

Reducing the Risk of Escalation
A swift response to consumer complaints can prevent small issues from escalating into larger problems. For example, a complaint about mislabeled THC content can be resolved through a refund or product replacement, but if left unaddressed, it could lead to regulatory scrutiny, fines, or a full product recall. Addressing complaints promptly can help operators resolve issues before they spiral out of control.

Operational Efficiency
Handling complaints efficiently can also improve overall operational efficiency. By addressing issues quickly, operators can identify potential problems in their production or supply chain early, allowing them to make necessary adjustments before more products reach consumers. This proactive approach can lead to better quality control, fewer recalls, and a more streamlined operation.

Leveraging eQMS Solutions for Complaint Handling
One of the most effective ways for cannabis operators to manage consumer complaints is by leveraging electronic quality management systems (eQMS), like C15 Solutions . These digital tools can streamline the complaint handling process, ensuring that issues are addressed quickly and compliantly.

Automating Complaint Receipt & Tracking
An eQMS streamlines the process of receiving, logging, tracking, and resolving complaints. By centralizing complaint data in a digital system, operators can ensure that all complaints are documented and addressed in a timely manner. Automated tracking also allows for greater transparency, making it easier for operators to monitor the status of complaints and confirm timely resolution.

Integrating your eQMS into external complaint sources, like an online customer complaint portal, a dispensary-managed complaint form, or even a provincial distributor like the OCS (‘Ontario Cannabis Store’), like C15 has done for many customers, means your QA team received instant notifications the second that complaint has been submitted. This streamlines the entire process, ensuring accurate data capture and accelerating verification, investigation, and resolution. We've observed a 70% reduction in cycle time, leading to a 233% boost in productivity.

Ensuring Compliance
Compliance is critical in the cannabis industry, and an eQMS can help operators stay on top of regulatory requirements. Many eQMS solutions are designed to meet industry-specific compliance standards, ensuring that complaint records are auditable and that operators can demonstrate their commitment to addressing issues in a timely and compliant manner.

Analytics and Reporting
An eQMS can also provide valuable insights into complaint trends. By analyzing complaint data, operators can identify recurring issues and take proactive steps to issue CAPA’s and Change Controls to improve internal processes and thus product quality. This data-driven approach not only helps reduce the volume of complaints but also enhances overall product safety and customer satisfaction.

Continuous Improvement
Complaint data should be used as a tool for continuous improvement. By analyzing the root causes of complaints and having detailed reports available compiling all your complaint data and trends, an enterprise can now make data-based, insightful business decisions re: where to supplement training, what might be the most likely resolution to a particular complaint based on historical data, which SOPs to potentially re-write, etc.

This type of a data-based, proactive approach to addressing organizational ‘gaps’ is precisely what regulatory authorities look for when auditing/inspecting operations. Mistakes will be a fact of life in any manufactured goods industry – thoroughly documenting them and proactively addressing them is exactly what regulators look for when auditing operations.

Regulatory, Compliance and Legal Trends Impacting The Cannabis Sector [Vol. 3, 2023/2024]

Mon, 13 May 2024 18:26:30 GMT

Employee Health & Safety in Cannabis

Fri, 05 Apr 2024 17:29:47 GMT

Employee Health & Safety (‘EHS’) is becoming an increasingly important topic in the cannabis industry. The Occupational Safety and Health Administration (‘OSHA’) is a vital agency within the United States Department of Labor. Its primary purpose is to ensure safe and healthy working conditions for employees by setting and enforcing standards and by providing training, outreach, education, and assistance. Unfortunately, back in 2022 there was a significant incident involving an employee's death from inhalation of ground cannabis dust at a Multistate Operator (MSO) facility. Reports, in the public domain, show OSHA investigators found the employee died from occupational asthma due to exposure to ground cannabis. One finding was that workers weren't provided enough information and training on the hazards involved in the production and grinding process. This incident illustrates the significance of both everyday hazards inside a cannabis facility as well as the responsibility of cannabis companies to prevent these incidents from occurring. In this blog, we will outline typical hazards as well as tools to assist cannabis operators in responding to OSHA inspections or similar agencies in other jurisdictions such as CCOHS (Canada) and EU-OSHA (Europe).

To give you an idea of the scope of OSHA, the org., along with its state partners, operates with approximately 1,850 inspectors responsible for the health and safety of 130 million workers across more than 8 million worksites. This ratio equates to about one compliance officer for every 70,000 workers. In fiscal year 2023, OSHA conducted a total of 34,267 federal inspections ( OSHA ). Within the cannabis industry, it has been observed that OSHA's involvement is likely to increase as the industry becomes more mainstream. This is particularly true in states like Colorado, where cannabis cultivation has become a significant industry. OSHA violations and fines, while not commonplace in the cannabis space, are expected to become more frequent, especially regarding issues like pesticide use in cultivation operations. To be very clear, despite the cannabis industry’s status as a federally illegal industry, it is very much still responsible for adhering to and complying with OSHA regulations ( https://mjbizdaily.com/osha-intervention-cannabis-industry-qa-jolene-donahue/ ).

The power of OSHA investigators ranges from fines to even stop work orders. Investigators have actual fact-finding powers under the laws and if, as an employer, you can not prove the actual facts on the ground at the time of any incident, then there is little power to mitigate the OSHA fact findings.

Cannabis cultivation and manufacturing involve a range of activities that can pose safety hazards if not properly managed. Here’s an outline of typical safety hazards and considerations in the cannabis industry:

1. Chemical Exposure

Pesticides and Fertilizers: Exposure to chemicals used in cultivation, including pesticides and fertilizers, can pose health risks. Proper handling, storage, and disposal methods are essential.

Solvents: In manufacturing processes, especially for cannabis concentrates, exposure to solvents like butane or ethanol can be hazardous.

2. Equipment and Machinery

Processing Equipment: The use of extraction machines, trimming machines, and other processing equipment can pose risks of injury. Proper training and safety equipment are necessary.

Pressurized Equipment: Equipment used in extraction processes can operate under high pressure, posing risks of explosions or leaks.

3. Electrical and Fire Hazards

High-Intensity Lighting: Grow operations often use high-intensity lighting that can increase the risk of fires and electrical hazards. This is one of the most commonly cited infractions.

Extraction Processes: Some extraction methods involve flammable solvents, increasing the risk of fires and explosions.

4. Air Quality and Ventilation

Mold and Pollen: The cultivation environment can promote the growth of mold and the spread of pollen, affecting air quality.

Volatile Organic Compounds (‘VOCs’): Solvents and other chemicals can release VOCs, requiring effective ventilation systems.

5. Physical Hazards

Ergonomic Risks: Repetitive tasks, such as trimming, can pose ergonomic risks. Ergonomic assessments and worker training can help mitigate these risks.

Slips, Trips, and Falls: Wet floors, uneven surfaces, and cluttered workspaces can lead to accidents.

6. Biological Hazards

Plant Allergens: Handling cannabis plants can expose workers to allergens that might cause reactions.

Pathogens: Cultivation environments can harbor pathogens harmful to humans.

7. Regulatory Compliance

Licensing and Inspections: Compliance with state and local regulations, including obtaining the necessary licenses and passing safety inspections, is crucial.

Worker Safety Regulations: Adherence to Occupational Safety and Health Administration (OSHA) standards and guidelines is mandatory.

8. Security Measures

Access Control: Due to the value of cannabis products, security measures to prevent theft and unauthorized access are necessary.

Data Security: Protection of sensitive business and customer data against breaches.

We’ve previously discussed the importance of the People Process Technology (‘PPT’) framework and that applies directly to an operator’s EHS mitigation strategies as well. Hiring people who care about safety, matters. Having properly written SOPs and a robust training program with respect to safety is critical. Leveraging technology for people to properly enforce processes & training as well as properly documenting any safety incidents is the final piece of the puzzle.

A digital EHS system – like the one included in C15’s eQMS - can significantly assist cannabis operators in responding to OSHA inspections by streamlining and enhancing various aspects of a safety and compliance program. Here’s how:

1. Data Organization and Accessibility

Centralized Documentation: Digital EHS systems allow companies to keep all safety and compliance documents in one place. This means that during an OSHA inspection, any requested documents, like safety training records or hazard assessments, can be easily and quickly accessed, demonstrating compliance.

Real-time Access: Inspectors may request to see records or documentation on the spot. A digital system allows for immediate access to these documents, which can facilitate smoother inspections.

2. Proactive Compliance Management

Automated Alerts and Reminders: EHS software can notify companies about upcoming deadlines for regulatory requirements, ensuring that they remain in compliance and are prepared for unannounced inspections.

Regulatory Updates: These systems often provide updates on changes in regulations, helping companies adjust their practices proactively to meet new standards.

3. Incident Reporting and Analysis

Streamlined Reporting: Digital systems simplify the process of reporting incidents, near misses, and hazards, ensuring timely documentation that is essential for both internal action and regulatory compliance.

Data Analysis: They enable detailed analysis of incidents and trends, helping companies identify areas of risk and implement preventive measures, which can be highlighted during inspections to demonstrate a proactive safety culture.

5. Training Management

Training Records: Digital EHS systems keep track of all employee safety training, including dates, topics, and scores from assessments. This information can be easily presented during an OSHA inspection to prove compliance with training requirements.

E-learning Modules: Some systems offer e-learning modules, allowing employees to complete required training efficiently, ensuring that everyone is up-to-date and reducing the risk of violations.

6. Audit and Inspection Readiness

Self-Audits: EHS software often includes tools for conducting self-audits, helping companies identify and correct issues before they become violations.

Inspection Checklists: Utilizing digital checklists aligned with OSHA standards can guide companies in maintaining compliance at all times, making real OSHA inspections less daunting.

7. Improved Communication

Stakeholder Engagement: A digital EHS platform facilitates better communication among employees, management, and external stakeholders by providing a common platform for sharing information and updates related to health and safety .

8. Documentation of Corrective Actions

Action Tracking: When issues are identified, either through internal audits or OSHA inspections, a digital EHS system can track the progress of corrective actions, documenting steps taken and timelines, which is critical information for regulatory bodies.

Implementing a digital EHS system enables cannabis companies to maintain a robust safety program, ensuring not only compliance with OSHA regulations but also a safer work environment. By leveraging technology, companies can more effectively manage their health and safety obligations, making the process of navigating OSHA inspections more efficient and less stressful.

Developing and enforcing meticulous health & safety practices has now become ‘table stakes’ for the industry and failing to do so puts an operation at obvious risk for compliance violations or even worse, actual health & safety incidents. Reach out to C15 today to see how we can help https://www.c15solutions.com/demo .

From Seed to Sensation: Back-End Quality vs Front-End Quality

Thu, 22 Feb 2024 18:47:00 GMT

Introduction

Welcome to the dynamic world of the cannabis industry, where the quality of the final product is much more than meets the eye. In this blog, we're going to explore what really goes into making elite cannabis. For the purpose of this blog, we’re going to deconstruct ‘quality’ into two forms – front-end quality (consumer facing attributes) and back-end quality (production & regulatory attributes). At a high-level, we can think of front-end quality as how it smokes/affects us, and we can think of back-end quality as the safety & consistency associated with the product. This deconstruction and exploration will take us from the visible traits like the plant's appearance, potency, aroma, and purity to the behind-the-scenes action at the growing facility itself - the regulations, growing techniques, quality processes, and laboratory test results. It's not just about growing a plant; it's about a detailed and careful process that ensures what ends up in your hands is safe, consistent (or at least as consistent as possible) and of the highest standard. In other words, growing high quality cannabis is both an art and a science.

Section 1: Front-End Quality

First, we’re going to tackle front-end quality. Broadly speaking, front-end quality attributes are perceived more by end consumers. In no particular order, here are the most common front-end quality attributes that consumers typically use to evaluate their product:

Appearance → We’ve also heard the term ‘bud integrity’ used to evaluate the appearance of flower. Is the bud whole & dense, or does it have noticeable gaps? Has it been trimmed cleanly or sloppily? The color of the flower is also important – not that any one particular color is better, rather, does the color line up with genes of that particular cultivar? Finally, visual inspection of trichomes will tell a story as well. Generally speaking, the more the better (i.e. more ‘frostier’ looking). That said, an abundance of trichomes doesn’t tell the whole story; are they clear, milky white, or amber-ish/yellow? Clear means the flower may have been harvested too early and hasn’t been properly cured. Amber/gold means the flower was harvested too late and THC degradation has begun. Milky white = just right!

Potency → Much could be written here and potency is often subjective, but what is absolutely true is that there is much more than just the stated THC% telling a story here. When it comes to cannabis flower, there will always be an ‘entourage effect’, where many cannabinoids (as much as 100s!) will interact with each other to deliver a specific effect. As the wellness product market develops, consumers may be more interested in minor compounds like CBN or CBG rather than THC. Terpenes may also impact how potent we feel a product is. Bottom line, don’t evaluate the quality of flower on THC % alone.

Aroma → Often described as ‘head’ – the only rule of thumb that applies here is, the stronger the better! Much like color however, the aroma of flower should be specific to the genetics it came from. This is also where terpenes come into play. The higher the % of terpenes, the more ‘flavor’ a patient/consumer will taste. Like many front-end quality attributes, aroma is subjective and certain terpene profiles may appeal more to different consumers.

Purity → It goes without saying that a contaminant-free product is the desired outcome from a safety and quality perspective. The presence of powdery mildew (or ‘PM’, a white, powdery looking substance on cannabis flower) indicates a serious quality issue. It doesn’t necessarily mean it’s not safe to consume (though we wouldn’t recommend it), but it DOES mean the plant was sick and PM will adversely impact the purity and potency of the plant.

Section 2: Back-End Quality

There are a LOT of considerations when it comes to back-end quality. For instance, different cultivation techniques can influence flavour, potency and even how the flower smokes. Furthermore, the science of processing can have profound impacts on the preservation or degradation of final derivative products. Without getting prescriptive re: superior cultivation & processing techniques, (indoor vs outdoor, organic vs. non-organic, different post-harvest processes etc.) what we will say is that the formula for back-end quality could look something like genetic potential x grower expertise x quality assurance.

Genetics are the blueprint for flower. It goes without saying that bad genetics will seriously handicap your flower right out of the gate. Doesn’t matter how talented your grower is or how buttoned-down your QA team is, poor genetics = poor quality product.

Assuming you have good genetics and cultivation expertise (that best suits the facility), there is still the onerous task of building a QA team and implementing QA at the enterprise level. To be clear, QA is very different from QC, which is typically a single step towards the end of production whereby the final product is determined to have met or not met an internal quality specification. This would be considered ‘table stakes’, and is by no means a differentiating factor when it comes to enterprise quality.

To get a better understanding of how truly ‘enterprise’ quality assurance can be, we will highlight a few areas which are often overlooked:

Preventative Measures → T his includes everything from the selection of genetics to control of environmental conditions (light, temperature, humidity), soil & nutrient management, management of hazards & critical control points, and especially supplier qualification. As cannabis supply chains expand, so to does the risk to quality as one weak link in the chain can adversely impact the end product. Trust is KEY when it comes to supply chain partners.

Compliance and Regulations → Authorities and regulatory bodies demand adherence to regulations and audit your processes involving the back end of quality. Some states now have provisions that make having a quality management system in place to do just this. As de-scheduling becomes more of an expectation, this form of oversight will favor those who build brands based on the front and back-end approach to safety and quality. Those that cut corners or believe “quality does not sell” will not have a sustainable brand as regulations evolve.

Lab Testing → C onsidered a hot topic today in light of ‘THC inflation’ debates, the burden of testing does not entirely fall on third party testing laboratories. QA are usually responsible for the ‘sampling’ process which can not only influence testing outcomes but can also lead to wider discrepancies between potency claims made on a label, ultimately leading to customer dissatisfaction when they are not getting the product consistency they desire. This is especially true for medical patients that may sometimes require specific levels of potency. Furthermore, regardless of COA pass/fail results, QA teams should be tracking test results for individual analytes in order to do a proper trend analysis and ensure finished products are meeting their own internal specification as well. This best practice drives product consistency.

Section 3: Connecting Front-End and Back-End

Hopefully this blog has given you a more complete picture of quality in cannabis. The journey of cannabis flower from seed to consumer is a long one and consumers are often only privy to the post-harvest journey.

Back-end quality attributes like genetics selection , along with the strength of your growing and quality assurance teams will absolutely impact the front-end quality attributes that consumers typically ‘grade’ their flower by.

Connecting the front end and back-end does not require multiple solutions or confusing array of unintegrated platforms. It does require an approach that aligns the front with the back -end quality brand attributes in an easy and efficient (low cost) manner.

Of course, any business is resource-constrained and cannabis is no exception – in fact, one could argue it’s even more resource constrained that other regulated sectors like food & beverage or pharma given the tax burden and relative nascency of (constantly evolving) cannabis regulations. As such, it’s important to be as innovative as possible when it comes to managing the back-end of your operation.

Here is a shortlist of some examples of innovations in cannabis QA:

Advanced Analytical Testing Techniques → Advances in next-generation sequencing as well as spectroscopy and chromatography allow for more frequent and comprehensive testing

Cultivation & Harvesting Innovations → Automated climate control & monitoring systems as well as leveraging data analytics via IoT sensors ensures real-time quality management + better informed decision making

Digitized Quality Management Systems → D igitizing and automating an entire Quality Management System will save massive amounts of time all the while ensuring adherence to internal controls and external regulations alike. This results in a more compliant and more consistent product.

Furthermore, using a system like C15 Solutions that comes ready to integrate into complimentary systems like your ERP , S2S , environment controls , or even LIMS enables an operation to achieve true ‘enterprise’ quality assurance, while dramatically lowering associated production costs like waste, re-work, audit observations/penalties, recalls, etc.

A brand needs to build trust in the consumer and this best comes from holding front-end and back-end standards to the level of your brand attributes.

We encourage readers, be they facility managers, budtenders or consumers, to start asking more back-end quality questions to get the complete picture of the product they produce, sell or consume. Product education is a big theme for a sector fresh out of prohibition and, in our opinion, back-end quality doesn’t get the attention it deserves!

To Reschedule or Deschedule is the Question

Tue, 26 Sep 2023 19:55:39 GMT

The answer, my friends, is blowing in the wind (Bob Dylan). Almost to a person, the sector would prefer the FDA/DEA to remain out of the regulation of even medical cannabis and would want the full de-schedule option. This is extremely remote since the Department of Health and Human Services (“DHHS”), which houses the Federal Drug Administration (“FDA”), sent a private recommendation to the Drug Enforcement Agency (“DEA”) to reschedule cannabis to category III. Category III means it is less subject to abuse harms than I and II drugs and substances.

The Congressional Research Services Report, Sept 13, 2023, stated that the Schedule III category would mean “significant implications for state medical purposes but fewer for state recreational programs.” The report neglected to speculate on what these implications might look like. The report also stated that the DEA, to its knowledge, has never rejected an FDA recommendation on rescheduling.

Practical Implications:

First off, and arguably most important of all, this move would acknowledge what we’ve all known for quite some time – that there are medical benefits associated with the plant (albeit with the caveat that there is low to moderate potential for physical and psychological dependence). Like other schedule III drugs such as codeine or ketamine, medical cannabis will be legally available only by prescription.
From a patient perspective, this means two things: better outcomes over time (R&D + clinical trials inevitably means we will have a better understanding of which cannabinoids treat specific illnesses/symptoms) and it also means insurance coverage.
All cannabis producers will get immediate relief from the punitive IRS Code Section 280E provision which effectively taxes producers at 80% effective rate. Once category III is affected the average tax rate would be in the 28% range.
A non-punitive tax rate would free up hundreds of millions of internal capital and open the door for producers to list on US stock exchanges.
Because of the Schedule I category, most public producers are listed on the CSE or TSXV – Canadian stock exchanges. This economic catalyst would result in more liquidity, more institutional investors and more capital for the sector.
No interstate commerce even under Schedule III.
Medical cannabis would be subject to the Food, Drugs, Cosmetic Act (“FDCA”)
The federal regulation of medical state cannabis programs becomes more real than theoretical. We could see the imposition of good manufacturing processes(“GMP”). GMP is applied and adopted by the pharmaceutical and consumer packaged goods sectors regulated by FDA/DEA. General production practices (“GPP”) may not suffice for the FDA/DEA for medical cannabis.
Audit and regulatory oversight for medical cannabis, more than recreation, with a focus on audits and the integrity of the quality assurance process. The quality management solution becomes a focal focus to assess the health, safety and consistency of medical products under Schedule III.
We can envision a national enforcement role for medical “claims” that are not founded upon clinical testing for medical cannabis products.
More access to capital and listing on U.S. Exchanges.

Catalyst By-Products of Schedule III:

Better access to capital and banking. Normalized profits and ability to attract capital, bank normally and invest in the business.
Perhaps more M&A transactions amongst cannabis producers. There has been some “fear” that big pharmaceuticals would buy up the sector. To date, the number of medical cannabis companies with a drug identification number and an FDA approved product is no more than four. GW Pharma did the single notable acquisition medical cannabis while it was Schedule I. There is another small handful of drug focused cannabis producers in the world.
To date, tobacco and consumer packaged goods have invested in the recreation side of cannabis. Philip Morris International has made investments in cannabis medical device delivery mechanisms. BAT, Imperial Brands, and Altria have all made investments in cannabis producers.
A signal or nudge that assists pending legislation before Congress and the Senate on the cannabis sector.

Conclusion

The big win will be a financial one and the “cost” of this win will be the start of federal regulation for state medical cannabis producers. To have held a view that federal regulation of cannabis would never happen, and the states would remain with 100% regulatory control over medical and recreation cannabis seems to have always been a naïve view. This is the start of a national regulatory regime.

Wild cards include the timeline for DEA acceptance of the FDA recommendation. The passage of other legislation in the meantime that could impact this decision. The political landscape and the final wild card are international treaties that the U.S. may belong to that requires amendment, in a bilateral or multilateral fashion.

The Future of Traceability: The Impact of eQMS on Electronic Batch Records

Tue, 15 Aug 2023 21:36:10 GMT

Traceability is a fundamental element in ensuring product quality, safety, and compliance. Whether it's cannabis, pharmaceuticals, or food and beverages, being able to track and document the entire production process is essential. With advancements in modern technology, traditional paper-based systems are gradually giving way to more sophisticated and efficient solutions. One revolutionary development in this realm is the adoption of Electronic Batch Records powered by electronic Quality Management Systems (eQMS).

What are Batch Records?

A batch record serves as the life history of a product batch, documenting all processes and steps it undergoes to become the final product. It includes essential information such as dates, growth stage transitions, location changes, nutrient application, Integrated Pest Management (IPM) tasks, and all cultivation and processing steps outlined in Standard Operating Procedures (SOPs).

It also must include any quality-related issues during the production process - whether there was an unplanned deviation, an issue with input (raw) materials, or even testing of the final product (i.e. an out-of-spec Certificate of Analysis or ‘COA’).

For a robust quality assurance program, it is crucial to ensure that batch records are exceptionally detailed. However, creating such detailed batch records demands significant time and effort from both Quality Assurance and Operations teams, potentially causing delays in batch release and overall production timelines. QMS streamlines these efforts without compromising quality or compliance. Plus, without linking your executed batch records to the master batch record in your library, there is also a risk of not referencing the correct version.

The Evolution of Batch Records: From Paper to Electronic

For decades, industries have relied on paper-based batch records to document the step-by-step processes involved in manufacturing products. While these records served their purpose, they were not without limitations. Paper-based systems were time-consuming, error-prone, and challenging to maintain, especially in companies dealing with high production volumes.

The emergence of electronic systems began to transform these challenges into opportunities. eQMS offers a centralized platform for document control, training, deviations, and other quality processes - becoming a game-changer in terms of traceability!

C15 Solutions consolidates key information such as sanitation records, quality investigations, COA results, supplier corrective action requests (‘SCARs’) and equipment calibration records. The platform’s Automated COA Analysis provides an instant pass or fail result, accompanied by a visual trend analysis that facilitates the batch-release process, ensuring conformity with target specifications.

Ensure production readiness with visibility into your equipment status.

Learn how else C15 is empowering cannabis businesses.

How eQMS and Electronic Batch Records Revolutionize Manufacturing

Real-Time Data Capture

Immediate visibility into operations enables companies to identify and rectify issues promptly. Decision-makers can access live data, enabling a faster response to potential problems and ensuring product quality remains uncompromised.

C15 gives you real-time visibility into the bottlenecks across your operation.

Reduced Risk of Errors

Manual data entry often leads to errors. eQMS eliminates this risk by governing the entire batch run with stage-gated workflows, thereby automating data capture, minimizing human intervention, and maintaining data integrity.

Enhanced Compliance

In highly regulated industries, the U.S. Food and Drug Administration's (FDA) Current Good Manufacturing Practices (cGMP) require proof of proper handling for every step of the production process. Batch records and other types of manufacturing documentation demonstrate this level of accountability.

eQMS allows companies to create standardized workflows and enforce compliance across the organization, making audits smoother and less time-consuming. Moreover, eQMS offers compliant e-signatures, a requirement for 21 CFR Part 11 compliance ( ONLY eQMS offers this feature - ERP, S2S & MES platforms do NOT offer compliant e-signatures).

Interconnected Systems

eQMS platforms integrate with other critical systems like environment monitors/controls, Enterprise Resource Planning (ERP) platforms, and Laboratory Information Management System (LIMS) platforms. This interconnectedness ensures a seamless flow of information across the organization, enabling better collaboration between departments.

Version Control and Audit Trails

Keeping track of changes to batch records is crucial for maintaining an accurate historical record. eQMS offers robust version control and audit trail capabilities, allowing users to view previous versions, track changes, and understand the sequence of events during the manufacturing process.

Data Analytics and Continuous Improvement

When you have your batch-run process handled by your eQMS, the production team gets visibility across the entire operation. Relevant SOPs are associated with each production process and equipment calibration and status can be verified pre-run. Batch-runs can be linked to real-time quality investigations and processed accordingly.

Plus, by leveraging analytics, companies can enhance overall efficiency, resulting in cost savings and higher-quality products! C15 has developed an eQMS platform that enables companies to reduce their cost of quality by 30-40% To give further context into how large those savings are, they typically represent anywhere from 10-20% of overall operating expenses - based on actual C15 customer ROI analyses.

Above & beyond automated pass/fail analysis, C15 allows you to trend COA results.

Training Management & Competency

An eQMS platform can track employee training and competencies, ensuring that personnel involved in the batch-run process are adequately trained and qualified for their respective roles.

Mastering the Digital Shift

Companies that embrace electronic systems and leverage their benefits will position themselves at the forefront of quality management but there are some considerations that companies must address during implementation.

Initial Investment: Transitioning from a paper-based system to eQMS requires an initial investment in technology, training, and integration. However, the long-term benefits outweigh the upfront costs.

Data Security: As data becomes digitized, ensuring its security and protection against unauthorized access becomes paramount.

User Training and Adoption: Proper training and change management is crucial to ensuring that employees embrace the new electronic systems. User buy-in and adoption are essential for the success of any eQMS implementation.

Regulatory Compliance: While eQMS can enhance compliance, companies must ensure that electronic systems meet regulatory standards such as 21 CFR Part 11.

The future of traceability lies in the seamless integration of eQMS and Electronic Batch Records as you can eliminate paper from the line with industry-leading technology.

Looking to maintain a sustainable, competitive edge? Book a demo today.

How to Drive Sustainable, Long-Term Growth in Cannabis

Mon, 17 Jul 2023 16:13:08 GMT

The significance of industry standards within the cannabis sector cannot be emphasized enough, as they establish the market as legitimate and trustworthy. By upholding these standards, the sector not only gains credibility but also opens the door to further regulatory acceptance and improved levels of quality, safety, and consumer satisfaction, which ultimately, fosters sustainable, long-term growth.

Let's delve into the significance of industry standards and the efforts being made to establish them in the cannabis sector.

The Importance of a Shared Vision

Establishing industry standards requires collective efforts and collaboration among industry leaders, regulatory bodies, and organizations. One prominent organization working towards this goal is ASTM International's Committee D37 on Cannabis . This committee, formed in 2017, is dedicated to developing and maintaining standards for cannabis, its products, and processes - it was a natural fit for C15 Solutions!

C15 has recently joined the committee and will be actively contributing to the development of industry standards. Not only will C15 be contributing to standard development by sharing best practice workflows, but the committee’s expertise and best practices will also help C15 refine customer workflows as standards evolve. This type of collaboration ensures that standards align with industry needs, driving continuous improvement in product quality, safety, and compliance.

Revolutionizing Cannabis Operations: How ASTM D37's Guide Can Transform the Industry

In a groundbreaking move, ASTM D37 has acknowledged a pressing need for Quality Management Systems in the cannabis industry . Their latest proposal aims to establish a comprehensive guide that will revolutionize the way organizations involved in cannabis consumer products operate. By encompassing all aspects from cultivation to distribution, this guide seeks to foster robust Quality Management Systems in both the medicinal and recreational sectors.

With the introduction of this guide, regulatory bodies now have a powerful tool to ensure compliance and guarantee the production of high-quality and standardized goods. In addition, companies in all verticals across the cannabis supply chain would now have a framework to develop their Internal Quality systems to meet market demands and regulatory bodies. This major step aligns the cannabis industry with other heavily regulated sectors, such as food and pharmaceuticals, where consumer safety and product consistency are paramount.

Exciting developments have also taken place on the state level, with New York and New Jersey taking significant strides in cannabis production regulation. Both states have now mandated that producers operate under a Quality Management System, with strict requirements for record-keeping and traceability throughout the cultivation and manufacturing stages. Missouri is another state that has mandated cannabis businesses implement a Quality Management System - by requiring this, the state ensures the industry is operating in a safe, responsible, and consistent manner, while also setting cannabis operators up for long-term success. This underscores the importance of implementing standardized processes, especially in the absence of federal regulation.

How Standardization Gaps Impact Cannabis Operators

While some progress has been made, there are still numerous areas that lack standardization. Key aspects such as quality event procedures, training processes, lab testing methods, waste recycling, and banking procedures face the need for standardized approaches. These aspects currently see challenges like inconsistent testing results, inadequate training procedures for quality management professionals, unclear classification and production methods, difficulties in accessing capital, and rising insurance premiums. The absence of uniform guidelines and standardized rhetoric contributes to inefficiencies, operational challenges, increased risks, and higher expenses for cannabis operators.

While the industry awaits comprehensive standardization, operators are left grappling with a fragmented landscape. To paint a picture of how difficult it is to scale, many states have different marketing regulations, production standards, AND testing requirements.

However, Quality Management Systems can provide a solution by harmonizing certain processes and procedures across operations while allowing for customization where needed. Quality Management Systems not only enable operators to exercise control over their operations but also accelerate the standardization process once regulatory frameworks are established - win-win!

Learn how C15 impacted Vantage Hemp Co. when the company adopted its eQMS platform.

The Building Blocks of a Responsible and Competitive Cannabis Market

The benefits of standardization in the cannabis sector are numerous and can have a positive impact on consumers, businesses, and regulatory bodies. Here are some key advantages:

Enhancing Product Quality and Safety

Implementing robust industry standards helps maintain uniformity and minimize variations in product quality. By setting guidelines for cultivation, processing, manufacturing, and distribution, these standards ensure that cannabis products meet specific quality benchmarks. This promotes consistency, reduces defects, enhances the overall customer experience, and safeguards the public by reducing the potential health risks associated with the consumption of contaminated products.

Building Consumer Trust and Confidence

Consumers need assurance that the products they purchase are safe, reliable, and of high quality. Industry standards serve as a mark of quality and consistency, enabling consumers to make informed decisions. When consumers see that a product adheres to established standards, they feel confident in its safety and efficacy. This, in turn, fosters brand loyalty and encourages repeat purchases.

Fostering Research and Innovation

By providing a common language and framework, these standards facilitate collaboration among businesses, researchers, and regulatory bodies. They enable the collection of reliable data, which can be used for comparison and analysis. This scientific and industry advancement is instrumental in driving innovation, promoting best practices, and pushing the boundaries of knowledge in the cannabis sector.

Driving Growth and Legitimacy

Standardization creates a level playing field for businesses, encouraging responsible practices and fair competition. It also attracts investment and partnerships from stakeholders

who value professionalism and compliance.

The Roadmap to Sustainable Growth

The cannabis industry's growth and potential can only be fully realized when standardization is prioritized. The implementation of a comprehensive Quality Management System is crucial to achieving these goals, enabling operators and regulators to navigate the industry with greater efficiency and confidence while consumers can expect reliable and safe products.

By partnering with forward-thinking technology providers, such as C15, cannabis operators can leverage standardized and automated methods to improve quality, consistency, and compliance (while lowering their operational costs!).

Choosing the right vendor is a critical process that demands careful consideration and we’re here to help you learn more.

The cannabis industry is poised for a transformation that will elevate it to new heights - book a demo with C15 today.

C15 Solutions and AlphaRoot Join Forces to Bring Innovative Technology and Insurance Solutions to Cannabis Operators

Tue, 27 Jun 2023 15:48:21 GMT

NEW YORK, June 27, 2023 -- C15 Solutions Inc. (“C15”) and AlphaRoot have formed an innovative partnership that enables cannabis operators to access competitive insurance premiums while gaining a comprehensive review of their insurance and quality programs.

C15 offers an electronic Quality Management System (‘eQMS’) platform designed to enhance quality and compliance while minimizing operating costs in the cannabis industry.

While AlphaRoot is more than an insurance broker; specializing in comprehensive risk management solutions tailored to its clients' needs. Both offerings align closely with the values of each company; risk mitigation and quality management. Just like C15, AlphaRoot is committed solely to serving the cannabis sector.

“We are extremely excited about this very natural partnership,” said Sean Samuel, VP of Sales and Marketing at C15. “Proper compliance and risk management should have tangible benefits and now C15 customers and the industry at large can benefit from superior risk ratings and better access to insurance at lower costs.”

“When considering strategic partnerships, we look for alignment in culture, service, and expertise. Above all, we look for partnerships that will have a positive impact on our clients. The collaboration between AlphaRoot and C15 not only meets but exceeds all of our desired characteristics,” said Hunter Baldwin, Commercial Cannabis Risk Advisor at AlphaRoot. “The combination of C15's innovative platform, AlphaRoot's insure-tech platform (app.alpharoot.com), and the comprehensive insurance and risk management services that we provide to clients create a natural synergy. This partnership is expected to enhance our clients' risk profiles as they continue to scale.”

About C15 Solutions Inc.

C15 delivers a customized eQMS (Electronic Quality Management System) platform exclusively for the cannabis sector to enhance the quality, safety and consistency of cannabis products while lowering operating costs. The company is a leading tech partner to a global customer base of operators, cultivators, processors, manufacturers of cannabis products, and labs. C15 has a proven track record of isolating and reducing the cost of quality for its customers while strictly adhering to all industry jurisdictional regulations. Visit www.c15solutions.com .

About AlphaRoot Insurance

AlphaRoot is a full-service insurance brokerage and advisory firm that works exclusively with the cannabis, hemp, CBD, holistic medicine, and psychedelic industries. The company has clients across the entire supply chain, from new licensees to public operators, and extends out to ancillary and capital providers. The AlphaRoot team believes that in order to stay on the vanguard for their clients, an intense

focus on the challenges their clients face is a necessity. Ultimately, the AlphaRoot goal is to become a trusted source for insurance and risk management strategy and implementation, fueling their clients’ growth. Visit www.alpharoot.com .

The Crucial Link: The Role of eQMS in Ensuring GMP Compliance

Wed, 21 Jun 2023 21:40:19 GMT

Good Manufacturing Practices (GMP) are fundamental to maintaining the safety, quality, and consistency of products across various industries. The cannabis industry faces increasingly stringent compliance requirements to safeguard consumers and enhance product integrity. To meet these demands, cannabis operators are turning to electronic Quality Management Systems (eQMS) as an indispensable tool in achieving and maintaining GMP compliance.

What is GMP?

GMP is a meticulously designed framework that ensures products are consistently manufactured according to quality standards. Regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), enforce GMP regulations to protect public health and mitigate risks at every stage of the manufacturing process.

GMP plays a proactive role in quality assurance, encompassing a wide range of elements including materials, premises, equipment, storage, record keeping, staff training, hygiene, complaint handling, and product development.

The impact of GMP extends globally, with over 100 countries having incorporated the World Health Organization's (WHO) GMP provisions into their national medicines laws and many more countries adopting its approach as a guiding framework to establish their own national GMP requirements. Certifications such as EU-GMP (Europe), cGMP (U.S.), or Guide 104 GMP (Canada) are essential for compliance in their respective regions.

Further insights can be obtained from the World Health Organization's resources on GMP.

The Pathway to EU-GMP Compliance for Cannabis Operators

The European Union (EU) has implemented strict regulations regarding the import and export of cannabis products, with one of the key requirements for cannabis operators to obtain EU-GMP certification.

This certification process involves a comprehensive evaluation of the entire cannabis supply chain, from cultivation to manufacturing, packaging, labelling, and distribution. By imposing such requirements, the EU aims to increase consumer confidence and create a level playing field for cannabis businesses operating within its jurisdiction.

A significant number of C15 Solutions’ customers have leveraged eQMS to adhere to EU-GMP regulations (while simultaneously lowering their cost of quality!). C15 has also garnered a solid reputation with EU regulatory bodies, including the Medicines & Healthcare product Regulatory Agency (MHRA) and the Therapeutic Goods Administration (TGA), who have confirmed 100% EU-GMP validation of its eQMS platform.

To put it simply, if you aspire to EU-GMP status and a ‘pharmaceutical-grade or consumer packaged goods (CPG)” level of quality, you must have a document control and quality management system fully deployed.

Global medical cannabis is a compliance business - see how C15 can help.

Quality Variability in the U.S. Cannabis Industry: How Fragmented Regulations Impact Consumers

In contrast, the United States has a more fragmented regulatory landscape for cannabis with varying standards from state to state, leading to a patchwork of different rules and quality control measures.

While certain states in the U.S. have implemented stringent measures and testing requirements for cannabis products, others have relatively lenient regulations or limited oversight. Consequently, consumers are left to question which products are safe and reliably labelled - they may encounter variations in potency, purity, and contaminants depending on where they are sourced. CPG business models demand product consistency state-to-state, notwithstanding the regulations.

The lack of standardized quality requirements at the federal level in the U.S. has prompted calls for more uniform regulations and harmonized standards across the country. Efforts are being made to establish federal guidelines for cannabis quality control, including testing protocols and labelling requirements. In the meantime, multi-tenant, cloud-based eQMS platforms like C15 are the remedy; they enable operators to harmonize certain processes and procedures nationally while customizing others and adhering to a variety of quality standards across the respective states.

C15 also recently joined the ASTM D37 Cannabis Committee in an effort to help standardize processes and procedures across the USA (more to come on this in our next blog!).

GMP Compliance Made Easy: The Role of eQMS

Now, let’s explore the significance of eQMS in ensuring GMP compliance and how it benefits cannabis companies in streamlining their operations.

Streamlining Document Management

GMP compliance requires meticulous control and documentation of procedures, specifications, and records, proving eQMS to be invaluable by centralizing and digitizing the entire document management process. It eliminates the need for manual paperwork and reduces the risk of errors or lost documents. With eQMS, cannabis operators can effectively manage documents, ensuring version control, accessibility, and traceability.

Ensuring Effective Training and Competence Management

A well-trained and competent workforce is crucial for GMP compliance. eQMS provides a platform for managing training programs, tracking employee competencies, and documenting training records. Standardized training modules can be created, progress can be monitored, and skill gaps can be identified. Automated notifications and reminders ensure timely training and certification renewals, mitigating the risk of non-compliance.

Facilitating Corrective and Preventive Actions (CAPA)

Corrective and Preventive Actions (CAPA) are a vital component of GMP compliance, aimed at identifying and rectifying non-conformances while preventing their recurrence. eQMS streamlines the CAPA process by providing a centralized system to record, track, and manage corrective and preventive actions. Real-time visibility into the status of CAPAs ensures effective implementation of corrective measures, minimizing risks and enhancing product quality.

Enabling Change Management

Change control is essential for managing and documenting modifications in processes, equipment, or systems. eQMS simplifies change management by offering a structured framework to evaluate, approve, and implement changes while maintaining an audit trail. This ensures transparency, accountability, and adherence to GMP regulations throughout the change management process.

Supporting Audits and Inspections

GMP compliance demands readiness for audits and inspections from regulatory authorities. eQMS plays a crucial role in preparing organizations for these assessments by providing a centralized repository of compliance-related information. This allows organizations to easily demonstrate GMP compliance, reducing the time and effort required for audits and inspections while ensuring a smooth experience.

Real-Time Data Analytics and Reporting

eQMS platforms generate real-time data analytics and reports, providing valuable insights into quality-related metrics, trends, and performance indicators. These analytics enable proactive decision-making, process optimization, and identification of areas for continuous improvement. By leveraging these insights, cannabis producers can enhance their compliance with EU-GMP standards and demonstrate a commitment to ongoing quality enhancement.

Unlocking Sustainable Growth in the Cannabis Sector

As the cannabis industry continues to evolve, GMP compliance becomes increasingly vital for maintaining product quality, consumer safety, and regulatory adherence. eQMS emerges as a crucial link in this journey. By embracing eQMS, cannabis companies can navigate the complex landscape of GMP compliance with confidence, setting the stage for sustainable growth and success in the industry.

Book a demo with C15 today.

Novel Insights on Technology and the Cannabis Sector: Barriers to Market Adoption of QMS

Thu, 01 Jun 2023 20:06:08 GMT

In today's dynamic cannabis landscape, characterized by heightened regulatory demands and consumer expectations, Quality Management Systems (QMS) play a pivotal role for operators, mitigating risks, driving operational excellence, and ensuring adherence to production standards and best practices.

Despite the undeniable significance of QMS, its market adoption faces several barriers. Let’s delve into four major obstacles impeding the widespread acceptance of QMS in the cannabis industry.

Breaking Barriers: Unleashing the Power of QMS

Barrier 1: The Perception that "Quality Does Not Sell"

A prevailing misconception in the cannabis industry is that consumers prioritize factors like price and potency over quality assurance measures. However, this overlooks the growing demand for safe and consistent products among consumers and the potential brand damage caused by repeated complaints or product recalls.

According to aggregated data, businesses that have implemented C15 Solutions’ QMS have seen significant improvements on average, including a decrease in customer complaints by 42%, unplanned deviations by 25-35%, and corrective and preventive actions (CAPAs) by 45-55%. Additionally, many customers have been able to reduce investigation times from an average of 30 days to close vs. 7 days to close.

C15 is reinforcing Philip Crosby’s ‘Quality is Free’ adage; in most cases, the system pays itself back!

Check out more stats in C15’s annual customer ROI case study for a large, multi-site company.

Barrier 2: A Focus on Seed-to-Sale or Tracking Solutions

Seed-to-Sale systems are valuable tools for tracking product movement and preventing diversion, but they fall short of addressing the critical aspects of product quality, safety, and consistency. Similarly, Enterprise Resource Planning (ERP) and Point of Sale (POS) systems focus primarily on financial reporting and sales management, respectively. While Learning Management Systems (LMS) often lack specificity and fail to meet the compliance standards set forth in 21 CFR Part 11.

QMS, on the other hand, offers a comprehensive solution that improves productivity, reduces the cost of quality, and ensures product consistency across multiple markets. C15 Solutions also knows it is imperative for organizations to implement Employee Health and Safety (EHS) systems that incorporate OSHA reporting capabilities, which is why C15's EHS module seamlessly integrates with the OSHA online portal, ensuring compliance and maintaining workplace safety.

By integrating key components of the IT stack, such as batch records, suppliers, and equipment, QMS bridges the gap and establishes a robust foundation for quality assurance.

Barrier 3: Governance and C-Suite Ignoring Liabilities

Governance and C-Suite executives may not fully comprehend the liabilities associated with non-compliance or product safety issues. This lack of awareness often leads to inadequate investment in QMS. However, the consequences of poor quality management can be severe, ranging from false content of THC and label errors to supply chain risks and a lack of trained employees.

C15 is dedicated to enhancing the quality, safety, and consistency of all cannabis products by implementing best practices through the use of QMS. While maintaining the current minimum standards of Good Production Practices (GPP) and Good Manufacturing Practices (GMP), widespread adoption of QMS would instil every producer with superior economics and best practices, ensuring a higher standard across the industry.

As the cannabis regulatory regimes and private sector players strive for larger-scale operations, it becomes imperative for producers to establish robust partnerships with technology experts. These partnerships will enable producers to navigate the evolving landscape and meet the increasing demands of the industry. By doing so, they can effectively mitigate insurable risks and protect their businesses.

To learn more, read C15’s open letter to cannabis companies on risk.

Barrier 4: Budget Constraints as a Limitation to Productive Technology Investment

Budget constraints have often limited investment in productive technology within the cannabis industry. While the focus has been on diversion tracking, it is now imperative to shift attention toward technology that focuses on production productivity.

Notably, New York and New Jersey have made it mandatory to incorporate QMS into their new cannabis regulations , emphasizing its significance in the industry. Industry bodies like the ASTM Committee D37 on Cannabis are also recognizing the importance of QMS and its role in promoting standardized practices.

C15 has demonstrated remarkable case studies in which customers have achieved significant reductions in the time required to address deviations, conduct investigations, and bring high-quality products to the market. Manual processes that once took weeks or even months have been streamlined to as little as 3 to 5 days.

Learn how C15 reduced Vantage Hemp Co.'s time required to close investigations.

Through collaborative efforts with various cannabis sector brokers, C15 has witnessed insurance underwriters lower the risk ratings (and discount certain policy premiums accordingly) of companies who have implemented C15's QMS. This trend indicates a growing recognition of the effectiveness and reliability of QMS in mitigating risks.

The ultimate goal, often referred to as "a Holy Grail," is to ensure that products reach the market immediately after production with 100% compliance and without compromising quality. Achieving this level of efficiency and integrity is made possible through the implementation of a state-of-the-art QMS solution and optimized processes.

Why Embracing QMS is a Strategic Imperative for Modern Businesses

Based on comprehensive data spanning over four years and encompassing more than 4,000 users across five countries, C15's QMS consistently delivers exceptional return on investment (ROI). On average, the ROI exceeds 750% per annum (often surpassing 1,000% by the second year of implementation!) which further validates the substantial benefits of deploying a QMS solution.

Embracing QMS is not just an option but a necessity. It is a strategic decision that can transform businesses, positioning them for long-term success. By prioritizing education and informed decision-making, organizations can navigate the challenges of change and future-proof their business.

Book a demo with C15 today.

5 Things You Need To Know To Successfully Scale Your Business

Mon, 29 May 2023 20:12:13 GMT

Originally posted on Authority Magazine .

Startups usually start with a small cohort of close colleagues. But what happens when you add a bunch of new people into this close cohort? How do you maintain the company culture? In addition, what is needed to successfully scale a business to increase market share or to increase offerings? How can a small startup grow successfully to a midsize and then large company? To address these questions, we are talking to successful business leaders who can share stories and insights from their experiences about the “5 Things You Need To Know To Successfully Scale Your Business”. As a part of this series, we had the distinct pleasure of interviewing Sean Samuel.

Sean Samuel is Vice President of Sales and Marketing at C15 Solutions, a technology company that delivers a life sciences-based eQMS platform tailored for the global cannabis sector and adjacent industries. Sean has a sales and business development background that spans the tobacco and finance sectors. Currently, Sean manages the sales process at C15, spearheads marketing initiatives, establishes key strategic partnerships, executes product demos, and secures valued customers. Sean has helped grow the company from scratch to 65+ corporate customers across 8 countries.

Thank you for joining us in this interview series. Our readers would love to “get to know you” a bit better. Can you tell us a bit about your ‘backstory’?

My career is an intersection of three things I love — cannabis, technology, and innovation on a global scale!

When Canada initially mulled over federal legalization, I was working at the Bank of Montreal and had long been speculating on the early medical cannabis companies in small-cap portfolios. Shortly after Canada passed adult use, C15 Solutions was formed, and it was C15’s partnership with Veeva Systems (VEEV:NYSE) that really intrigued me. They have long been an established tech provider to the Life Sciences and CPG industries, working with multinational corporations like Kraft, Nestle, Bayer, Pfizer, Unilever, and more. Cannabis always struck me as an amalgamation of agriculture (cultivation), pharma (medical), and consumer packaged goods (adult use) so, adopting best practices from those established sectors and adding to the quality and safety of cannabis production was a mission I could embrace.

I was already keen on trying to help accelerate the sector’s trajectory when it came to being a leader in the industry, especially as it globalized. The opportunity to work with such an innovative and supportive partner in Veeva, as well as being able to build something from scratch (opposite of my situation at BMO) with a fantastic management team at C15, was what ultimately drove me in this direction!

You’ve had a remarkable career journey. Can you highlight a key decision in your career that helped you get to where you are today?

Yes, as a matter of fact, it was a literal fork in the road. In 2017, I was working on Bay St. for one of the ‘big 6’ banks and was offered two new jobs — both were with start-ups (my type of culture/working environment) but one was in finance and the other, cannabis. The finance job came with significantly better pay and a small equity stake. The cannabis job was a riskier one that paid less and required commuting (vs. a 15-minute commute to Bay St.) and yet, the decision really wasn’t one I lost much sleep over, picking C15 with conviction.

Five years later, the start-up on Bay St. I almost joined is killing it, but I still have zero regrets in my decision. Why? Because this is my passion. Navigating the ‘wild west’ cannabis landscape and building a brand from scratch has been my most rewarding professional experience. Plus, I’m extremely proud of being part of the legalization of a wonderful plant with genuine medicinal properties.

What’s the most impactful initiative you’ve led that you’re particularly proud of?

That’s easy — C15 Solutions ! Our mission is to raise the quality and compliance bar for the entire cannabis sector, globally. That’s a lofty mission statement, however, we are unequivocally doing just that; we’ve taken a technology that is widely adopted in other regulated sectors like pharma, life sciences, and CPG, and we’ve tailored it specifically for cannabis operators, regardless of the jurisdiction they operate in. The result is higher-quality, safer cannabis products and maturing, compliant cannabis companies.

How has mentorship played a role in your career, whether receiving mentorship or offering it to others?

Mentorship has played a massive and pivotal role in my career. I would say I’ve had three professional mentors over the course of my career thus far and each was instrumental in either inspiring me to change my professional trajectory or refine and accelerate my existing one. With that said, I’d love to give a quick shoutout to Rob Butler , Carter Davidson, and my father, Scott Samuel, for their wisdom and inspiration over the years. All three have meant so much to me for different reasons.

Developing your leadership style takes time and practice. Who do you model your leadership style after? What are some key character traits you try to emulate?

I genuinely do not have a single leadership ‘model’ in mind. I’ve been fortunate enough to work with a variety of executives (at big and small companies) and to play with many captains and coaches during my competitive hockey days. This has allowed me to adopt specific traits such as direct, transparent communication and identify ones that are not my style such as immediate, cut-throat judgment. I don’t think there’s a ‘perfect leader’ out there, rather, perfect fits of team and leadership.

Based on your experience, can you share with our readers the “5 Things You Need To Know To Successfully Scale Your Business”?

Efficiency . As C15 grew, we had to listen to what the market was telling us and learn and adapt our sales and service strategies to become more efficient. Whether it’s tinkering with your outbound process or how you engage with your customers, we’re constantly looking to become more efficient so that our customer acquisition cost is lower, and our customer engagement is higher.

A Growth Plan . Whether it’s new products or new markets, research and analysis MUST be done and a ‘growth at all costs’ plan will often result in self-destruction. In the cannabis sector especially, which is both highly competitive and highly regulated, a growth plan must be well thought out, deliberate, and ideally vetted by trusted stakeholders.

Team. Hire to build a culture, not to fill roles.

Partners. As the saying goes, ‘it takes a village to raise a child’ and in business, it takes the right partners to reach the next level. In our case, C15 has the best tech partner we could possibly ask for in Veeva Systems, as well as incredible shareholders like Emily and Morgan Paxhia from Poseidon Asset Management.

Financing. This is kind of a technicality more than anything. Obviously, capital is required to scale but I think nuance lies in what kind of financing… Debt? Equity? What terms? Who are the shareholders? It takes strong, experienced leadership to nail this part.

Can you share a few of the mistakes that companies make when they try to scale a business? What would you suggest to address those errors?

Hiring for a job vs. hiring the right person and finding them work to do was a mistake we made in the beginning. As a start-up, you might have an idea of how you want your company to be structured and how it looks down the road, however, one of the lessons I’ve learned is that building the right culture is integral for a young company and maintaining that culture as you scale is just as important. This is why we’re now more in tune with the ‘people’ we hire vs the ‘role’ we hire.

Scaling includes bringing new people into the organization. How can a company preserve its company culture and ethos when new people are brought in?

Answered in the above question — hire for people, and not roles.

Many times, a key aspect of scaling your business is scaling your team’s knowledge and internal procedures. What tools or techniques have helped your teams be successful at scaling internally?

I think we do two things extremely well at C15 to scale our knowledge AND our culture.

Hybrid work model — We employ roughly a 70/30 work-from-office/work-from-home model. This hybrid model is very important to us as it enables us to learn from each other and collaborate much more efficiently while simultaneously delivering a work/family balance that is quite rewarding.
Lunch & learns — We schedule periodic lunch & learns (on the days when most of the team is in the office) and everyone rotates through being the ‘teacher’. They will speak to role-specific issues, team-specific issues, or even macro/tech-related issues and this usually generates some colourful team discussion!

What software or tools do you recommend to help onboard new hires?

Our Sales Team uses Hubspot as our CRM of choice and that’s a big part of our onboarding process — the entire sales journey and pipeline is effectively captured here. The Customer Success Team leverages Totango to track the deployment journey and customer health, so that’s also integral to the onboarding process of new hires.

Because of your role, you are a person of significant influence. If you could inspire a movement that would bring the most amount of good to the most people, what would that be? You never know what your ideas can trigger.

My answer to this hasn’t changed since I last spoke with Authority Magazine, so I’d still say make the conscious decision to step away from your devices and other digital distractions, in order to fully engage with the present moment and the people around you. I find myself in a similar position of looking for the right balance when it comes to tech of any kind, but especially AI. I absolutely see some of the merits of AI but I’m similarly apprehensive about some of its potential as well — look no further than Chaos GPT…

How can our readers further follow your work online?

You can keep up with C15 on Twitter and LinkedIn.

This was truly meaningful! Thank you so much for your time and for sharing your expertise!

Unlocking Your Full Potential: How eQMS Transcends the Limitations of a Manual System

Tue, 09 May 2023 20:06:20 GMT

Despite the growing demand for high-quality cannabis products, many operators still rely on manual quality and record-keeping systems, overlooking the competitive advantage of an electronic Quality Management System (eQMS). A manual approach can lead to production errors, delays, and non-compliance with industry standards, while an eQMS provides a streamlined approach to quality management, data capture and analysis, as well as ensures compliance - let’s find out how.

The Pitfalls of a Manual System

A manual system is a record-keeping method that relies on paper or basic content management platforms like Office, Sharepoint, or Dropbox. With this system in place, everything from document creation to reviews and approvals, plus the subsequent training required, must be done manually, which can be a time-consuming and labour-intensive process.

In complex business operations, you need a source of truth . Manual systems often lead to inconsistencies in documentation as version history must be tracked manually and simultaneous edits can ruin its integrity, making it difficult to locate and retrieve data. Further, documents might not be adequately secured, and data might be accessed and downloaded by users who should not have the ability to do so.

Compliance challenges also arise with manual systems, especially in a rapidly evolving cannabis industry, as it's difficult or impossible to reference or link standard operating procedures (SOPs) to specific regulatory content and make dynamic changes to relevant SOPs when the associated regulations inevitably change.

Manual systems also make it extremely difficult to manage training, as they lack actionable analytics or insights. Without technology to teach and reinforce processes, new employees are often overloaded with administrative work and training, which significantly extends the time required for them to become proficient (which nobody wants!).

Manual systems are simply not up to the task of managing modern businesses as compliance with regulations is not scalable with a manual process. To remain competitive, companies need advanced systems that can handle the intricacies and complexities of today's environment. We need to look no further than the widespread adoption of eQMS in other regulated sectors like pharma and consumer packaged goods to illustrate how integral this technology really is.

eQMS - A Must-Have for Your Cannabis Business

An electronic Quality Management System is a comprehensive software solution designed to aid cannabis companies in managing and maintaining their critical processes. Through the power of technology, eQMS platforms offer a range of advanced features that automate quality management processes, streamline workflows, and enhance overall operational efficiency.

Learn more about C15’s eQMS exclusive focus on the cannabis industry.

The empirical evidence speaks for itself: C15 Solutions’ average customer report card from 2022 revealed an impressive 750% earned combined ROI for document, training, and quality event management. Additionally, the average approximate reduction in operating expenses was a staggering $1,000,000 . Many C15 customers get their deviations and investigations cleared in not weeks, not months, but a few days - this means your products get to market faster and with greater safety, quality, and consistency.

Learn how C15 reduced operational costs and increased ROI for Vantage Hemp Co.

Figures like these demonstrate the transformative impact of eQMS on the cannabis industry and the critical role the system plays in enhancing business performance and growth. Let’s learn more.

How Technology Can Revolutionize Cannabis Operations

Streamlined Processes

One of the key benefits of eQMS is that it allows for automated workflows, which can save time and effort, as well as minimize human error. With a few clicks, documents can be created, reviewed, approved, and stored, streamlining the entire process. Automation helps ensure that documents are reviewed and approved by the right people at the right time , minimizing delays and eliminating the need for manual follow-ups.

Consistent Documentation

eQMS provides standardized templates for documentation, ensuring consistency across different teams, departments, and sites. Standardization is essential for creating a repeatable process that is easy to follow and easy to audit.

Easy Data Retrieval & Analysis

With eQMS, all documentation is stored in a central database, making it easy to retrieve data and analyze it to identify trends and opportunities for improvement.

Improved Compliance

eQMS also offers automated tracking and alert features. These attributes guarantee that all documentation is kept up-to-date and in alignment with regulatory requirements, helping facilitate a smooth and successful audit process.

Furthermore, eQMS provides an effortless way to reference and link SOPs to specific regulatory content. This function allows for dynamic changes to relevant SOPs, ensuring they remain current and updated as regulatory changes occur.

Better Visibility & Accountability

eQMS enables company leadership to identify and address potential issues before they escalate into problems with a user-friendly platform that makes it easy to track who has accessed documents and when. This added layer of accountability helps to increase transparency and enhance communication.

The increased visibility has a cascading effect, reducing operational and supply chain risk by mitigating potential disruptions before they occur.

Scalability

Manual systems are costly and inflexible. Automating admin, compliance, and QA processes with eQMS ensures high ROI and helps you scale quicker (with less risk). The automation provided by eQMS can free up valuable resources, allowing your company to focus on growth and innovation.

Operational Cost Reduction

eQMS adoption reduces the number of complaints, unplanned deviations, product recalls, and rework/scrap, thereby reducing your operating expenses and cost of quality, while simultaneously improving your bottom line and reputation.

Interested in going digital? Schedule a demo with C15 today.

C15 Solutions Anticipates Substantial Growth in European Cannabis Market Through Innovative Tech Platform

Thu, 20 Apr 2023 12:00:34 GMT

Leading tech vendor sees promising growth for European operators, commits to advancing the industry with an EU-GMP ready eQMS platform.

Oakville, Ontario, April 20, 2023 - C15 Solutions (“C15” or the “Company”), a technology vendor delivering a customized eQMS (‘electronic Quality Management System’) for the cannabis sector exclusively, is confident about its growth potential in the EU for 2023 and beyond with many EU and UK operators currently using its platform including valued customers like Canify AG, Celadon Pharmaceuticals, Endosane Pharmaceuticals GmbH, Belfry Medical, and 4C LABS. With Germany on the cusp of passing cannabis regulations, the Company anticipates other EU operations to step up and leverage eQMS to elevate the quality, safety, and consistency of cannabis products while lowering the costs of production.

“Having a robust eQMS platform is not only essential for obtaining EU-Good Manufacturing Practice (‘GMP’) but also maintaining the certification. The EU-GMP certification is required for manufacturers to sell medicinal cannabis products in the EU and is a prerequisite for many export markets as well. A strong eQMS is vital for ensuring patient safety and product quality,” says Sean Samuel, C15’s VP of Sales and Marketing. “Medicinal cannabis is a highly regulated product, and deviations from the required quality standards can lead to significant health risks and loss of patient trust.”

C15’s customers have leveraged the Company’s solutions to adhere to EU-GMP regulations while simultaneously lowering their operational risks and costs. EU regulatory bodies are also intimately familiar with the Company and have confirmed 100% EU-GMP validation of C15’s eQMS platform, including the Medicines & Healthcare product Regulatory Agency (‘MHRA’) and the Therapeutic Goods Administration (‘TGA’).

C15 has identified unique characteristics of the EU market that make eQMS a perfect fit for domestic operators. These characteristics include:

A fragmented regulatory landscape as each sovereign member of the EU will end up with its own laws and regulations, creating regulatory complexities for companies operating in multiple jurisdictions.
A focus on medical cannabis means a strong emphasis on product quality, safety, and consistency – the latter of which is an important distinction when it comes to medical vs. adult-use products.
Limited domestic production means many countries rely on import partners, introducing supply-chain complexity and an increase in the propensity for product quality issues.
High standards for product quality from European regulators which means detailed and specific requirements for quality control, testing, record-keeping, as well as training.

C15 customers represent a culture of quality and as a result, the Company has been able to create connections between North American and European businesses that have resulted in mutually beneficial trade. By upholding partner standards that prioritize quality and integrity, C15 has built a clientele of like-minded organizations that understand the value of trust in business relationships. The Company plans to continue growing its customer base in the EU throughout 2023.

About C15 Solutions

C15 Solutions (pronounced see-one-five) is a leading tech partner to cultivators, processors, and manufacturers of cannabis products around the world. The company delivers a customized eQMS platform for the cannabis sector exclusively. C15 Solutions strictly adheres to all jurisdictional regulations and has a proven track record of isolating and reducing the cost of quality for its customers.

For more information on how C15 Solutions enhances the cannabis industry, please visit https://www.c15solutions.com/ .

For further information, please contact:

Sean Samuel

Vice President, Sales and Marketing at C15 Solutions

sean.samuel@c15solutions.com

Brooke Russell

Marigold Marketing & PR

brussell@marigoldpr.com

The Importance of Vendor Selection

Thu, 30 Mar 2023 18:27:26 GMT

The cannabis industry is undergoing rapid evolution and maturation, with businesses seeking ways to both survive and stand out in a crowded marketplace. A crucial factor in determining the success or failure of these businesses is the selection of the right technology vendor. Choosing the right partner is a critical process that demands careful consideration.

Businesses operating in this space are facing an increasing number of technology choices, whether it's seed-to-sale tracking solutions, compliance software, or customizable eQMS.

Before you start vetting technology vendors, it's essential to clearly identify your business needs by taking a close look at your current processes, identifying pain points of the business such as your cost of quality, and determining what areas of the organization could benefit from tech solutions (if not, all of them!).

Aligning Objectives with Vendor Capabilities

As the only eQMS vendor serving the cannabis industry exclusively, C15 Solutions has developed a customized platform tailored for the industry through a team of dedicated SMEs with backgrounds in pharma, QA, finance, and retail.

Our experience shows that cannabis companies seek vendors who can help their business…

Stay compliant by providing a centralized platform for tracking and managing quality-related data
Ensure consistent quality by providing a standardized process
Streamline processes and improve efficiency by reducing the need for manual data entry
Facilitate collaboration and communication between different teams and stakeholders
Reduce errors and miscommunications
Ensure that everyone is working towards the same quality goals
Drive continuous improvement by providing a platform for tracking quality-related metrics, identifying trends and patterns, and implementing corrective actions when necessary

Take Vantage Hemp Co., for example. In 2021, the company sought out a partner to develop a customizable, cloud-based quality management system to automate and enforce processes and ensure the highest level of cGMP compliance.

Learn more in our case study.

How to Vet Tech Vendors and Find the Right Partner for Your Business

Now that you’ve identified your business needs, here are some tips on how to vet potential vendors:

Experience

It's essential to work with a vendor who has a proven track record of success in the cannabis industry - ask for case studies to evaluate the vendor's past performance.

For instance, C15 has grown from scratch to 65+ corporate customers across 8 countries, working with 60% of the top 10 cannabis companies.

Industry-Specific Knowledge

This aspect is crucial in the cannabis industry, where there are unique and ever-changing regulatory and compliance requirements that vendors must be aware of. Look for a tech vendor who understands the industry's intricacies and can help you navigate the regulatory landscape.

C15 is a global vendor that ensures customized regulatory compliance based on each customer's jurisdiction, future-proofing businesses for the evolution of the regulatory environment.

Ongoing Technology Enhancements

Your business needs technology that is constantly evolving with the industry and can be customized to your specific needs. As your business grows, your technology needs will likely change so it's important to evaluate vendors not only on their current offerings but also on their ability to scale.

Read how C15 has amplified its eQMS platform to become a ‘business organizational tool’.

Customer Service and Maintenance Capabilities

Technology is never perfect, and it's essential to ensure your vendor has a support team that can quickly address issues. Additionally, check if they provide regular maintenance and updates to keep the technology up-to-date.

One of C15’s customers identifies the importance of a vendor’s customer success team, “I have been working with C15 for over a year in developing our custom, cloud-based QMS system. They are very responsive to my needs and are quick to develop.”

Industry Reputation

Request references from existing customers and partners to evaluate their track record and reputation in the market.

Hear what our customers are saying about us.

Quality of Products and Services

The quality of products and services provided by a vendor can have a direct impact on your business operations. It is essential to ensure that your vendor's quality standards align with your business to avoid any negative impact on your reputation or lost business opportunities.

Cost Savings

One way to reduce your cost of quality is to work with vendors who value quality. At C15, we have developed a solution that can help companies reduce their cost of quality by 30-40%.

Check out C15’s exclusive with Benzinga on how to save 30% of your top-line revenue.

Strategic Alignment

Choose a vendor that aligns with your strategic goals. If your business prioritizes a 'culture of quality,' working with vendors who are dedicated to reducing the cost of quality can help you achieve your goals.

Risk Mitigation

By thoroughly vetting potential vendors, businesses can identify potential risks and take steps to mitigate them. It is crucial to look for vendors with a strong track record of regulatory compliance.

Integration

As the cannabis industry continues to evolve, operators are upgrading their technology stacks to keep pace with the demands of the market. It becomes imperative for vendors to seamlessly integrate with the operator’s existing infrastructure. It’s essential to evaluate whether a vendor offers a comprehensive API library, any integration limitations, and common connection points.

Smooth integration is crucial for cannabis companies looking to optimize workflows, minimize disruptions, and improve overall efficiency.

Total Cost of Ownership

When evaluating the cost of a tech solution, it’s essential to consider the total cost of ownership (TCO) holistically. This includes not only the upfront license fees but also other expenses such as maintenance, configuration, and training fees. Moreover, it’s crucial to be aware of any additional charges, including professional service fees that some vendors may levy on top of their SaaS license fees.

To avoid any unpleasant surprises, it’s recommended that potential buyers ask for customer ROI case studies from the vendor as they can provide valuable insights into the real-world value of the solution and help you anticipate any additional expenses that may arise during the process.

Unlocking Success

While vendor selection requires careful planning and execution, the rewards can be substantial, both in terms of financial savings and strategic advantages.

Make an informed decision that will help your business thrive. Schedule a demo today.

A Case Study on the Commitment to Quality and Compliance: Vantage Hemp Adopts C15 Solutions’ EQMS

Wed, 15 Mar 2023 15:56:42 GMT

How To Lower The Cost Of Cannabis Quality And Save 30% Of Your Top-Line Revenue

Thu, 16 Feb 2023 19:53:55 GMT

Originally posted on Benzinga .

Cannabis companies of all sizes are struggling to increase their profit margins and to make that happen, they're implementing different strategies. Lowering prices and premiumizing products are among the alternatives to create value. In addition, cannabis companies might look at risk mitigation as an alternative to achieve higher quality and prevent losses.

How can cannabis companies ensure higher quality with a sustainable ROI? Or, how cannabis companies can achieve premiumization at a lower cost?

A quality management system (QMS) might help. QMS are popular in many industries. Automobiles, planes, medical devices and cannabis companies are no different when it comes to quality assurance. Likewise, electronic QMS are software tools that offer cannabis companies an automated means to record and manage all business-critical information, mitigate risk, ensure quality standards and comply with a myriad of regulations.

Good Costs, Poor Costs

The cannabis industry can be viewed as an amalgamation of regulatory elements of pharma, agriculture, consumer packaged goods, food and beverage. However, there are nuances. Regulations can take many shapes and “that's where companies like G15 come in,” Sean Samuel , VP of Sales and Marketing told Benzinga in an exclusive interview.

C15 delivers a life sciences-based electronic Quality Management System platform to raise quality, compliance and safety standards.

“We are considered a risk mitigation tool. We're solving the cost of quality which it's not the cost of goods sold. Typically will not show up on a P&L statement. However, these are massive costs that typically represent anywhere between 25 to 35% of your top-line revenue. The cost of quality can be broken down into good costs and bad costs,” Samuel said.

“The good costs are things like, a risk management procedure, validation, internal audits, table stakes when it comes to quality management. The poor costs are where the cost of quality can skyrocket. Any time a batch doesn't get released because there's been mold contamination. Costs that aren't tangible to a lot of C-suites in the cannabis space.”

Disaster Prevention

According to Samuel, good costs can be seen as an opportunity. Any time there are customer returns, complaints, there's damage to the brand reputation, these are foregone sales that companies could have had. Without mentioning a recall. That can be an absolute disaster.

While executives from cannabis companies spend hours thinking about how to create value for stakeholders, a 2-micron mold spore can destroy everything in one harvest.

Samuel explained that resorting to a system such as C15’s can significantly increase the chances of unfortunate events like that. For a graphic description, he provided an example.

“The sixth largest licensed producer in Canada lost their license because they were doing non-compliant things and they had very poor record-keeping. They got delisted from the Toronto Stock Exchange,” Samuel said. “We are talking shareholder value destruction to the tune of like tens of millions, all because of record keeping. It's not a cost that you can just reduce your expenses on. If not managed properly, the cost of quality can represent millions,” Samuel added, referring to quality management, as a “core task to kill a mess.”

Integrate Everything

From inventory, which is typically what an enterprise resource planning system (ERP) would address, to environmental controls, G15 can monitor and evaluate everything.

Over 300 open applications enable software to communicate to cover the entire supply chain and ensure that protocols and regulations are met.

“Our system comes preloaded with validated audit workflows for supplier qualification, external audits, and internal audits. When the supplier is approved, the system sends a message to the production team, so they know they can purchase from them,’” Samuel said. “You can put that supplier on hold.”

"Our system is effectively the blueprint for production as well as the remedial actions for when things go wrong in the production process. We connect the whole facility.”

Proven Efficiency

To expand to international markets, C15 has gone through the EU GMP validation process from top to bottom. The company has customers in eight different countries, including New Zealand, Australia and Uruguay. And some of them are in emerging international EU GMP markets, such as the United Kingdom.

In addition, the firm partnered with publicly-traded $25 billion company Veeva Systems Inc. (NYSE: VEEV ), operating in the biotech sector. Bayer (OTC: BAYRY ), Pfizer (NYSE: PFE ), Merck & Co. (NYSE: MRK ), GSK (NYSE: GSK ), Unilever plc (NYSE: UL ), and Kraft Heinz (NASDAQ: KHC ) are among its clientele.

Samuel noted that global cannabis companies, MSOs, and larger single-state operators are gravitating towards C15 seeking an alternative to navigating different regulations, with one single software system.

And provided an example of how C15 is currently working with cannabis MSO Curaleaf (OTC: CURLF ).

“Through our system, Curaleaf harmonizes certain processes and procedures across its national footprint while customizing others. We can tailor document approval workflows for different states. Employees can see certain SOPs, and training material, whereas the C-suite can see everything across the operation,” Samuel explained.

Training and Retail

Cannabis companies can have anywhere between 500 to 1000 Standard Operational Procedures and they might make revisions to half of them over an annual basis. Every time companies make changes to an SPO, they need to retrain the impacted staff so they know they're using the latest and greatest procedures. And that's a ton of training.

Thus, C15 evolved its training above and beyond just SOP compliance training, and it now comes with what Samuel calls “a full-blown training management solution” that allows companies to develop a role-based curriculum.

“You may have a generic curriculum that deploys that applies to all employees, and then a role-specific curriculum that can be any training requirements you want. Training requirements could be SOPs, they could be videos, they could be PowerPoint scoring files, quite literally, anything. We've rolled out this training solution that trickles down, from production to retail stores,” Samuel said.

‘J.D. Power, have you heard of that?’

“We aggregate a lot of production data, deviation data, complaint data… that is kind of like the next chapter of our company, we're very much looking at how to market this data.

“We're providing our customers with annual report cards. So based on an anonymous aggregate customer curve, looking at all our customer data, and how they can be leveraging the system,” Samuel continued.

“J.D. Power, have you heard of that? They offer a sort of quality curve for the automotive industry. J.D. survey customers and tell automobile companies how they sit on the broader quality curve. We're going to tell customers, here's where you can use the system. Here's where you're underutilizing the system,” Samuel concluded.

Regulatory, Compliance and Legal Trends Impacting The Cannabis Sector [Vol. 2, 2022]

Wed, 08 Feb 2023 19:05:00 GMT

Strengthening Company Culture with Effective Training Management

Thu, 02 Feb 2023 18:54:49 GMT

The Fundamentals Essential to Industry Success

If your cannabis company’s goal is to produce high-quality products in a cost-effective and compliant manner, you’re not alone. Many industry players are working to achieve this goal. It’s elusive yet achievable because to deliver consistent quality products, a business must build and maintain a culture that adheres to jurisdictional regulations and international standards.

This goal cannot be achieved without process improvement, effective training of all company employees and, ideally, technology in place to automate and enforce processes.

An eQMS enforces processes and record-keeping and generates data to drive better-informed business decisions. eQMS training technology ensures employees understand their rights and responsibilities, are aware of safety hazards, and can adequately execute tasks and record information as required for their particular job role - all while strengthening company culture.

Easing the Burden of Compliance

Employee training and subsequent training records are a critical part of governing regulations and compliance with training is an area that inspectors and customers will always check during audits.

Maintaining up-to-date records and tracking employee training to ensure compliance using a manual system is a considerable burden that often requires a dedicated person or an entire team. Manual administration allows for zero data or insights leaving training managers with little to no understanding of where the company’s biggest knowledge gaps are.

With individual employee records needing to be readily available during an audit or other inquiry, it is integral for a company to create a reliable, stable, and repeatable training management process to ensure your entire organization is up to date with industry standards and regulations.

Incorporating an effective training management process will create unified quality process training to achieve compliance, easy onboarding for new employees, role-based qualification, and quality event-related training. An effective process will also generate periodic training to guarantee that employees know their roles and responsibilities, are aligned with business objectives, and can constantly improve skill levels in QMS-related areas.

The Role Training Technology Plays in the Organization

Technology is designed to automate the administration and grading of all employee training and enables a continuous improvement strategy. The result of that is an increase in operational efficiency and consistency, less regulatory risk, and an audit-ready organization with a single source of truth.

Employee turnover is extremely high in the cannabis industry. With that said, training technology can build employee competency, ensure retention, and align training curricula with business goals. Role-based curricula address turnover quickly and effectively with data insights that ensure compliance by role, provide you with access to qualification dashboards, and allow you to monitor training trends with ease.

C15’s Solution

C15 offers companies various options for maintaining training records, depending on their training approach.

Read and Understood Training with E-Signature (21 CFR Part 11) Acknowledgement

Read and Understood training is available to everyone with a C15 eQMS license and alerts the licensed user that they have been assigned a training task on their home screen task page.

Training Storage Solution for Training Performed Outside of the System

For our customers that perform manual training or training outside of C15, the Training Storage Solution allows training records to be captured within the system through attachments and e-reports can still be generated via C15 dashboards.

C15’s Enhanced Training Management System or TMS

The Training Management Solution (TMS) allows customers to build curriculums per job role, assign the curriculum to applicable employees, and implement quizzes for a quantitative level of understanding. The added benefit of TMS is the automation of training - the module will automatically assign training tasks to the applicable employees whenever an SOP or other document that requires training is updated.

No matter which approach is taken for training, C15 has the solution for easy reporting and monitoring.

Find out why C15’s eQMS is a genuine ‘business organizational tool’.

Establishing a Culture of Quality

Training is absolutely critical from a compliance perspective. However, it is less obviously used as a competitive advantage or as a tool to establish a genuine ‘culture of quality’ . The only way to build such a culture is to invest wisely in your people , processes, and technology .

Over-reliance on either one or two out of the three will leave your operation open to unnecessary risk, leave profit on the table, or both. People leave and processes change; technology can minimize the associated disruption.

Schedule a demo with C15 today.

How to Understand and Manage the Cost of Quality

Thu, 12 Jan 2023 18:55:24 GMT

Quality Simplified

Contrary to the traditional definition of quality, the Cost of Quality encompasses an organization’s entire production process developed to meet its product standard.

Defined by the American Society of Quality , the Cost of Quality is a methodology that enables producers to calculate how much of their resources are spent on activities preventing poor quality and is used to assess the quality of the organization’s goods and services and gauge the results of internal and external failures.

The Cost of Quality (CoQ) is illustrated by the sum of two components - the Cost of Good Quality (CoGQ) and the Cost of Poor Quality (CoPQ) .

Now, let’s define those components…

The Cost of Good Quality (CoGQ) includes the total number of activities a business partakes in to ensure that its customers receive a product or service of the best possible quality.

Prevention costs are planned costs to ensure every process is in place. These include:

Developing and implementing a Quality Management System (‘QMS’), quality planning, education, training, process capability, APQP/DFSS, FMEA, and FTA

Appraisal costs are costs associated with determining the effectiveness of a QMS affecting both producers and the supply chain. These include:

Calibrating, auditing, testing, verification, maintenance, market research, incoming inspection, in-process inspection, and final inspection

The Cost of Poor Quality (CoPQ) can occur during a company’s operations and even haunt you after products are shipped. The hidden costs of poor quality (opportunity cost of lost sales, excess inventory, additional procedures, complaint investigations, damage to brand reputation, and increasing visits from regulators) are often much greater than the visible costs that organizations track (rejection, repair cost, rework, and the cost of inspection).

To be clear, the hidden costs of poor quality will NOT show up on a P&L statement. These costs are embedded throughout the organization and typically represent anywhere between 20-35% of top-line revenues .

Internal failure costs are costs incurred when a company discovers quality failures prior to the delivery of items to customers. These include:

Process delays, rework, scrap, retesting, CAPA/RCA, and capacity loss

External failure costs are the most substantial costs and are usually only evident after the products have been delivered. These include:

Customer returns, loss of customer sales, low customer satisfaction, and brand distrust

Enabling a ‘Culture of Quality’

With legalization creating one of the fastest-growing industries of our time, the emerging market has seen institutional voids. Designed to foster this growing market, a Quality Management System (QMS) ensures both emerging and established companies are in a better position to ensure quality, data integrity, and compliance.

Hear from Curaleaf’s VP of Quality Assurance in our latest press release.

Depending solely on compliance without considering the Cost of Quality may result in a few unexpected costs or significant waste - both having the potential to harm the bottom line and damage company reputation.

A cannabis company’s C-Suite tends to be ‘blind’ to the costs of both good and poor quality because many of them are tough to quantify. For example, damage to reputation via complaints and recalls or the cost of contaminated batches that do not end up getting released.

Nonetheless, these costs exist.

Managing Your Cost of Quality

Now, it’s time to manage. Identifying cost opportunities, things your company can do to improve its performance, and calculating an issue’s true expense can provide your business with the tactics and clarity you need to reduce the Cost of Quality.

With that said, improvements need to be a top priority on everybody’s list.

Enabling you to focus on core activities, business objectives, and KPIs that actually count, investing in a QMS deters additional time spent revising poorly developed products, dealing with customer dissatisfaction, and handling process delays.

C15 Solutions serves 60% of the top 10 publicly-traded cannabis companies (by market cap.) and acts as an internal partner to its customers through a team of dedicated Subject Matter Experts with a strategic focus on reducing the Cost of Quality.

C15’s three years of aggregated data demonstrate that customers obtain a return on investment (ROI) between 750-1,000% (not a typo!) with multi-state operators saving millions of dollars per year in quality and production costs. With customized subscription renewal case studies provided to each of our customers, we ensure they are getting the most out of our system.

Learn more about C15’s efficiencies.

Addressing your company’s total Cost of Quality may seem overwhelming or costly but we urge you to consider the following quote from Benjamin Franklin, “The bitterness of poor quality remains long after the sweetness of low price is forgotten.”

C15 Solutions Continues to Empower Cannabis Businesses with Product Enhancements for 2023

c15.admin@c15solutions.com (Xin Guo) — Wed, 14 Dec 2022 17:30:52 GMT

Leading tech vendor amplifies its CPG-grade eQMS platform with upgrades that demonstrate the company’s product is “more than just a QMS”

Oakville, Ontario, December 15, 2022 - C15 Solutions (C15 or the “Company”), a leading tech vendor to the global cannabis industry, has unveiled various product enhancements to its electronic Quality Management System (eQMS). C15’s enhancements go above and beyond the scope of QMS with a series of developments that began in 2022 and are continuing into 2023.

“The cannabis sector moves quickly and so does the product team at C15. We are constantly solving problems for our customers and sometimes that means innovation outside of traditional QMS functions,” explains Roy Gazdar, Vice President of Product Development at C15 Solutions.

C15’s eQMS is used exclusively by the cannabis industry to reduce the overall cost of quality, reduce the risk of non-compliance with jurisdiction regulations, address deviations and complaints, and automate daily tasks. The Company’s three years of aggregated data demonstrate that customers obtain a return on investment (ROI) between 750-1,000% with multi-state operators saving millions of dollars per year in costs of quality and production.

In 2022, the Company began implementing Full Batch-Run workflows to enable governance and control over the batch-run process and provide version history and an audit trail for the Master Batch Record. C15 also enhanced the eQMS with electronic Batch Records to consolidate key information such as sanitation records, Certificate of Analysis (COA), and equipment calibration records. C15’s Automated COA Analysis is an instant pass or fail and is accompanied by a visual trend analysis that facilitates the batch-release process to determine if there is any drift from the target specification.

Gazdar continues, “Over the last year, we have made a series of enhancements to our eQMS platform that supports not only quality assurance, but also production, operations, and even HR. You could say we’ve made our eQMS a genuine ‘Business Organizational Tool’ - which one of our customers recently called it!”

C15’s Enhanced Training Management provides cannabis businesses with role-based curricula, automated grading, and full reporting across the enterprise. The Company also enhanced its Employee Health & Safety system this year, so that all health and safety investigations are kept under one roof.

C15 Solutions serves 60% of the top 10 cannabis companies, like Curaleaf, and acts as an internal partner to its customers through a team of dedicated Subject Matter Experts that have a strategic focus on reducing the cost of quality. "Having C15 as our eQMS vendor and industry partner has tremendously benefited our organization," says Nicole Leja, Vice President, Quality Assurance of Curaleaf. "As the cannabis industry evolves and becomes more structured, C15's expanded QMS is now an organization-wide tool, allowing us to keep multiple workflows in one system to maintain efficiency with user training."

C15’s eQMS has been specifically configured for cannabis but brings best practices from other regulated sectors such as the pharmaceutical and consumer-packaged goods industries. In 2023, the Company will be implementing a roadmap for labour planning and expects to deepen its impact on the industry with further enhancements.

For further information, please contact:

Sean Samuel

Vice President, Sales and Marketing at C15 Solutions

sean.samuel@c15solutions.com

Brooke Russell

Marigold Marketing & PR

brussell@marigoldpr.com

About C15 Solutions

C15 Solutions (pronounced see-one-five) is a leading tech vendor to cultivators, processors, and manufacturers of cannabis products around the world. The company delivers a customized eQMS platform for the cannabis sector exclusively. C15 Solutions strictly adheres to all jurisdictional regulations and has a proven track record of isolating and reducing the cost of quality for its customers.

For more information on how C15 Solutions enhances the cannabis industry, please visit https://www.c15solutions.com/ .

Sean Samuel of C15 Solutions: 5 Things I Wish Someone Told Me Before I Started Leading a Cannabis Service Business

c15.admin@c15solutions.com (Xin Guo) — Sat, 10 Dec 2022 17:36:40 GMT

Original Article by Authority Magazine

An Interview With Ben Ari

To survive and thrive in this industry, not only does your product have to be innovative and of high quality, but your management of the business needs to be just as innovative and more specifically, have the ability to pivot quickly. Whether it’s an approach to sales, marketing, billing, licensing, etc. Regulations and the competitive landscape are changing every day, and an ‘autopilot’ or ‘templated’ approach is a recipe for disaster.

As part of my series about “5 Things I Wish Someone Told Me Before I Started Leading a Cannabis Business ” I had the pleasure of interviewing Sean Samuel.

Thank you so much for doing this with us! Can you share the story about what brought you to this specific career path?

Mycareer is an intersection of three things I love — cannabis, technology, and innovation on a global scale!

When Canada initially mulled over federal legalization, I was working at the Bank of Montreal and had long been speculating on the early medical cannabis companies in small-cap portfolios. Shortly after Canada passed adult use, C15 Solutions was formed and it was C15’s partnership with Veeva Systems (VEEV:NYSE) that really intrigued me. They have long been an established tech provider to the Life Sciences and CPG industries, working with multinational corporations like Kraft, Nestle, Bayer, Pfizer, Unilever, etc. Cannabis always struck me as an amalgamation of agriculture (cultivation), pharma (medical), and consumer packaged goods (adult use) so adopting best practices from those established sectors and adding to the quality and safety of cannabis production was a mission I could embrace.

I was already keen on trying to help accelerate the sector’s trajectory when it came to being a leader in the industry, especially as it globalized. The opportunity to work with such an innovative and supportive partner in Veeva as well as being able to build something from scratch (opposite of my situation at BMO) with a fantastic management team at C15, was what ultimately drove me in this direction!

Can you share the most interesting story that happened to you since you began leading your company? Can you tell us what lesson you learned from that?

To survive and thrive in this industry, not only does your product have to be innovative and of high quality, but your management of the business needs to be just as innovative and more specifically, have the ability to pivot quickly. Whether it’s an approach to sales, marketing, billing, licensing, etc. Regulations and the competitive landscape are changing every day, and an ‘autopilot’ or ‘templated’ approach is a recipe for disaster.

We also quickly learned that our reputation would be built on not necessarily the product, but also our service. That’s something we take pride in and as of today, C15’s reputation for service and support is the single most valuable “asset” we have.

Can you share a story about your funniest mistake when you first started? Can you tell us what lesson you learned from that?

A funny mistake in our first year was assuming we could have a sales cycle of weeks after securing one demo of the solution… unsurprisingly, it’s a touch longer than that and we now demo to secure further demos as the user communities include QA, Operations, Legal, HR, and others.

Are you working on any exciting projects now? How do you think that will help people?

I think one of the most exciting things happening at C15 right now is our expansion into international markets like Western Europe, the UK, New Zealand, Australia, and South Africa.

These markets in particular seem to really ‘get’ the value of eQMS because they operate to EU-GMP production standards, which are higher and require more detailed record-keeping and validation of your processes, equipment, and software.

Our platform has been able to accelerate our customers’ ability to bring products to market as well as help to curry good favour with regulators along the way.

None of us are able to achieve success without some help along the way. Is there a particular person who you are grateful for who helped get you to where you are? Can you share a story?

My parents immediately come to mind — at one point in my life, I was consumed with playing in the NHL, and did come kind of close! However, when that dream was extinguished, I was directionless for a period of time. I had no idea what I wanted to do and even less of an idea of what I wanted to become. My parents, though clearly frustrated at times, never wavered in their support and attempts to inspire me. They invested so much time and energy (and money!) with the intention of raising the best possible son and have given me the foundation I need to be the best professional and father I can be.

I would also like to shout out a couple of institutions that helped me become the person and professional I am today — Dartmouth College & McGill University. Dartmouth is where my hockey career officially ended but it’s also where I met new friends for life and grew to appreciate the US. My two years at McGill were also unforgettable; I learned so much and met my wife while I was there!

This industry is young, dynamic and creative. Does your company use any clever and innovative marketing strategies that you think large legacy companies should consider adopting?

We engage in education at all levels. One of our favourite things to do is host smaller, invite-only events for prospects and customers that are usually timed with a larger industry-related conference. For instance, we took a group of customers to the Las Vegas Golden Knights game last year during the MJBiz Conference and did so again this year. Earlier in the year, we brought a small crew with us to the Formula One Miami Grand Prix!

We also plan on increasing our presence at trade shows via educational thought leadership but, generally speaking, we’re not fans of paid, digital marketing. Our competitive landscape is spending heavily on SEO terms — sometimes even against their own brand — and even buying up terms that aren’t relevant to that particular technology, which is a shame because this will confuse the user community.

All to say, that’s a very crowded and expensive space with less credibility. So for an innovative, forward-looking tech company, I would characterize our marketing approach as refreshingly ‘old-school’ and more community-based. Moving forward, we plan on featuring our customers more prominently in our marketing; sharing some of their success stories in a creative way.

Can you share 3 things that most excite you about the cannabis industry? Can you share 3 things that most concern you ?

Globalization of legal cannabis is by far the most exciting thing to me. I was very fired up when Canada paved the way, but we are effectively 10 minutes into a marathon here! C15 has looked at feet on the ground in Uruguay for the LATAM market and locations in the EU.

Hand-in-hand with that would be the globalization of C15. We hired our first fully-remote, US-based team this year and anticipate further growth as other markets continue to come online.

The other developing storyline that fascinates me is the development of brands! I think US operators have a leg-up in this respect. Many Multi-State Operators (‘MSOs’) are building out a very CPG-esque house of brands, with products that are positioned for different markets and lifestyles. The brand-based contract manufacturing business model is also one that seems to be thriving at the moment. Of course, a more complex supply chain is the trade-off for less of a physical production footprint, however, cloud-based eQMS solutions like ours make qualifying and collaborating with your manufacturing partners much easier.

Of concern to me would be the current cycle of price compression and regulatory overreach of the current economics of cannabis. Lots of regulatory challenges in all jurisdictions.

Can you share your “5 Things I Wish Someone Told Me Before I Started Leading a Cannabis Business”? Please share a story or example for each.

To be frank, I feel like I joined C15 fully expecting a world of change, adversity, and frustration — that’s part of starting anything new from scratch. I had been a part of a failing start-up previously, so I was under no delusions of grandeur. I suppose the one thing you could say was that I hadn’t anticipated these challenges being compounded by the fact that it was the start-up experience in a BRAND NEW industry as well! However, as the saying goes, ‘there’s no sweet without the sour’ and I can unequivocally say this has been the most rewarding work I’ve ever done.

I would add, being properly funded with great shareholders is an understatement.

What advice would you give to other CEOs or co- founders to help their employees to thrive?

I think one of our biggest management ‘lessons’ has been to hire people vs. hiring for the role. Obviously, there has to be a basic level of competency for the day job, but we quickly discovered that hiring the best person available, and finding work for them to do, was a much more sustainable approach. The benefits are obvious to us; our employees are seeing fantastic professional growth — after all, you don’t grow unless you try things you haven’t done before and make yourself a little uncomfortable — and we’ve developed a very cohesive team because we care about each other and don’t want to let each other down. There are no clock-watchers at C15.

You are a person of significant influence. If you could inspire a movement that would bring the most amount of good to the most amount of people, what would that be? You never know what your idea can trigger.

Perhaps somewhat ironically, I wish we (the human species) would be able to disconnect from technology more often! Unfortunately, one of the outcomes of better tech is less quality and more quantity. More relationships, more information, and more access, but how deep are those relationships? How accurate is the information? How safe and trustworthy is the access? It’s such a delicate balance; as an entrepreneur in a trail-blazing sector, I fully embrace technology. As a husband and father of three, I also have seen the value in ditching technology to be as present in a moment as I can possibly be.

With that said, technology is the single biggest driver of productivity in GDP and will remain that way for some time — use it at work, less at home!

What is the best way our readers can follow you on social media?

You can find C15 on Twitter and LinkedIn at: https://twitter.com/C15Solutions & https://www.linkedin.com/company/cannabis-onefive/?originalSubdomain=ca .

This was very inspiring. Thank you so much for joining us!

Risk Management 101: Avoiding Losses and Seizing Opportunities

c15.admin@c15solutions.com (Xin Guo) — Thu, 08 Dec 2022 17:22:09 GMT

Growing Pains

The cannabis industry has been blessed (or not) with exponential market growth and an oversupply of products. So what’s the secret to success in such a dynamic, fluctuating market? It’s two things: Delivering the right products at the right cost of quality.

The Quality Assurance and Operations functions have seen many industry challenges. With direct responsibility for compliance audits, reducing the cost of poor quality, supply chain efficiency, and delivery of high-quality products, these functions are instrumental in managing a company’s risk.

Cautionary tales have put a spotlight on the risk of non-compliance seen when companies improperly handle routine tasks or deviate from standard operating procedures, costing careers, revenue, shareholders, loss of time due to corrective action, or loss of license.

C15 Solutions interacts with international cannabis professionals daily to discover the priorities and best practices of the industry. Cannabis’ unique, industry-specific events require a risk management plan to reduce a company’s cost of poor quality while ensuring compliance.

The Risk Management Process

Risk is simply the uncertainty regarding outcomes. Thus, it is important for every cannabis company to understand and engage in proper risk management.

Risk is mitigated by people, processes, and technology. With increasing employee churn within the space and a general lack of stability, we see increased human errors. With an overwhelmed workforce we often find unaddressed quality tasks, deviations from SOPs, or inadequate training. Without the right technology, you end up with inadequately trained staff and the inability to prove compliance to regulators.

The experts of C15 have identified some of the significant costs associated with the cost of poor quality and running product liability risks. In the cannabis sector, the cost of quality can range from 15% to as high as 30% of top-line revenue.

Here are some other considerations:

Impact of complaints & recalls on your company’s brand reputation
Loss of revenues – products could be recalled, destroyed, or impounded
Loss to your stakeholders & equity value
Potential class action lawsuits from consumers
Potential license suspension and/or company closure and career-ending outcomes

Designed to foster a growing market, C15’s Quality Management Solutions (“eQMS”) enables cannabis companies to focus on their core activities and objectives while automating many critical, compliance-oriented processes across the operation.

Seizing Opportunities & Reducing Cost of Quality

Contrary to the traditional definition of quality, focused solely on consumer-facing product attributes such as freshness, bud integrity, and potency, operational quality permeates throughout the entire enterprise and production process.

The good news for cannabis is that the opportunity to reduce your company’s cost of quality significantly is at hand. C15 customers regularly achieve ROIs in excess of 1,000% and dollar savings from COGS in the millions per year.

C15 was created to fill a void in the industry - startups grow by finding a market niche that isn’t being served well by existing players. Focused on providing real utility to real people, C15’s products and services become vital to the success of cannabis companies looking to reduce the cost of quality and comply with jurisdictional regulations.

Check out our resource library to learn more.

Shifting from Reactive to Proactive

In an industry where the only constant is change, C15 ensures both emerging and established cannabis companies are in a better position to ensure compliance, quality, and data integrity.

With our experts’ extensive backgrounds in cannabis and its adjacent industries, this is what we have discovered are some of the main reasons cannabis companies ignore risk…

Lack of coordination
Mistaken over-dependence on people and processes rather than technology and industry best practices
A short-term focus on budget pause on IT spending
Lack of experience and expertise in GPP and GMP environments
Staff turnover
Little to no appropriate training
Lack of independence of quality professionals due to the reporting structure

Do not fall into the all-too “herd-like'' mistake of thinking: “I do not have the budget nor the bandwidth to investigate eQMS”. The cannabis industry is in its infancy compared to most industries - it faces a unique set of considerations determined by things out of your business’s control like jurisdictional regulations.

Vendors like C15 ensure that you are future-proofed for the evolution of the industry. You are ultimately retaining all the risks of loss until you put a risk management plan into action and arrange the details.

Schedule a demo with C15 today.

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c15.admin@c15solutions.com (Xin Guo) — Mon, 02 Aug 2021 14:01:39 GMT

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c15.admin@c15solutions.com (Xin Guo) — Fri, 19 Feb 2021 21:56:33 GMT

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c15.admin@c15solutions.com (Xin Guo) — Wed, 17 Feb 2021 21:53:48 GMT

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c15.admin@c15solutions.com (Xin Guo) — Tue, 29 Dec 2020 17:56:40 GMT