Cannabis (aka hemp or marijuana) is a wind-pollinating genus of flowering plants in the family Cannabaceae. This complex plant contains a group of chemicals known as cannabinoids, many of which have shown significant biological activity. Two cannabinoids in particular, cannabidiol (CBD) and delta-9-tetrahydrocannabinol (THC), have gained much recognition for their mental and physical effects when consumed. To date, over 100 different cannabinoids have been isolated from cannabis plants, and these compounds are generating significant interest in the pharmaceutical industry for potential drug and biologics production.  Cannabis Testing Labs must implement the right processes to keep pace with regulation and innovation.

With the legalization of both adult recreational and medical cannabis in a variety of states, there is a need for comprehensive and reliable analytical testing to ensure consumer safety and drug/product potency. Growing numbers of laboratories that specialize in evaluating cannabis and cannabis products are emerging to fill this niche. Typical lab testing on cannabis botanical samples includes:

• Potency
• Terpenes
• Strain (terpene/cannabinoid ratios)
• Residual solvents
• Pesticides
• Heavy metals
• Water activity
• Moisture content
• Foreign materials
• Mold and microbiological contaminants

Cannabis testing labs typically receive high volumes of test requests from cannabis growers and/or cannabis product manufacturers, and these labs need to develop effective data management strategies to stay competitive and maintain regulatory compliance. Using manual, paper-based methods (e.g., spreadsheets, notebooks, etc.) to gather, organize and control laboratory testing data is error-prone and time-consuming, especially as testing volume increases.

A Laboratory Information Management System (LIMS) is a software tool that allows for efficient data management and laboratory operation. LIMS can help to ensure regulatory compliance and provide the accurate and speedy results, reports, and certificate of analyses (COA) that are required for cost-effective operation in today’s highly competitive cannabis testing market. In this blog, we will discuss some LIMS features that can benefit cannabis testing laboratories, along with best practices for ensuring a successful LIMS implementation in your lab.

LIMS Features and Functions

Cannabis testing labs have to be able to stay in sync with the rapidly evolving regulatory requirements in this new and fast-growing industry. These labs also need to be able to operate cost-effectively and provide accurate and timely results to maintain competitiveness. LIMS provides a single, centralized database for all testing data, enabling effective data management and accessibility, along with a defendable quality assurance/control (QA/QC) framework to meet regulatory compliance.

LIMS provides data security and traceability from the moment a sample arrives in the lab, all the way through to final reporting and disposal. The LIMS tracks all testing data and parameters tested, along with corresponding test methods and paperwork (converted to PDF format) associated with the work order.

LIMS can track and manage other laboratory data as well to help ensure quality is maintained and operations run smoothly. For example, LIMS can be utilized to track reagent and supply expirations, incubator and freezer temperatures, instrument calibrations and employee training schedules and/or status.

A few of the many useful features and functions that LIMS can provide to cannabis testing labs include:

• Sample and split-sample tracking, allowing for an accurate chain of custody
• Positive ID (RFID, barcoding) from login to final disposition
• Chemicals, reagents, standards and supply inventory, order management and tracking
• Equipment management – maintenance and calibration schedules tracked
• Manual or automated (via instrument integration) data entry/transfer
• Stability testing modules
• Document management – method versioning, SOPs, manuals, etc.
• Resource management – instrument records, employee training records, etc.
• Workflow management – promotes better workflow efficiency and resource allocation
• Records comprehensive audit logs for laboratory activities along with the date and time stamp
• Data security and confidentiality – masks sensitive data from unauthorized user access
• Quoting and invoicing
• Integration with industry (e.g., seed-to-sale software, dispensary software, etc.) and enterprise (e.g., ERP, etc.) solutions for efficient data transfer, regulatory compliance and seamless accounting
• Automated and real-time reporting via export to a web portal or email
• Integrated web portal for 24/7 result access, sample submission, and locked report downloads
• Support for regulatory compliance and/or accreditations – ISO/IEC 17025, ISO 9001:2015, GLP, 21 CFR part 11, etc.

LIMS Implementation Methodology

Selecting, implementing and integrating a LIMS solution can be a challenging endeavor. In fact, nearly half of LIMS projects fail to meet one of more of the following metrics:

• is delivered on time and within budget
• meets or exceeds all user and technical requirements
• provides significant business value
• achieves a high-level of user adoption.

In order to ensure success, a comprehensive and proven methodology should be followed. This methodology should include strategic planning that leverages a workflow and business analysis to generate a set of optimized future-state requirements that will maximize business value for your organization. Instead of trying to implement a LIMS based only on your current workflows, why not implement your project in a way that optimizes your business? Without a clear strategic plan, companies often implement solutions in ways that do not support the business’s future goals.

Once a set of optimized future-state requirements are generated, it is time to select the LIMS that is the best fit for your system requirements. Care should be taken to choose the optimum hosting solution for your LIMS, which for cannabis labs is often a cloud-based system. Given that there are several LIMS options now on the market that are specifically designed for the cannabis industry, the selection process should be sure to include these vendors in the evaluation. Whatever system is chosen should be highly adaptable to enable staying in sync with the rapidly evolving regulatory requirements in this industry.

Finally, the project team should have significant technology expertise and experience designing, implementing and integrating complex solutions in a validated environment.

Conclusion

Given the highly competitive and rapidly changing nature of the cannabis industry, a LIMS is a necessity for high volume cannabis labs. In addition to reducing manual workloads and enhancing operational efficiency, a LIMS supports effective data management and security, along with regulatory compliance.

Astrix Technology Group has over 20 years of experience facilitating success in LIMS implementation projects. Since 1995, our professionals have successfully applied best practices in the evaluation of work processes, functional and technical requirements, laboratory processes and LIMS solution options for hundreds of clients and tens of thousands of scientists in a wide range of industries. Our exposure to hundreds of customer initiatives and expertise with many different LIMS allows for an enhanced understanding of what might be possible to optimize your laboratory environment.