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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.

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 ®gulatory 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!

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.

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.

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.

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 .

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.

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.

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

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.

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