LIMS is Critical in Achieving Regulatory Compliance for the Laboratory

Last month, ATL participated in Labroots’ Fourth Annual Cannabis Sciences Virtual Event. Our presentation, entitled Leveraging LIMS to Achieve Regulatory Compliance for the Cannabis Testing Laboratory discussed how a Laboratory Information Management System (LIMS) supports compliance. We’ve summarized the salient points here.

The cannabis industry is challenged in navigating today’s complex regulatory landscape. In the US, cannabis laboratories are required to be certified to the ISO 17025 standard. In order to effectively manage the increasing volume of associated analytical and ancillary data, LIMS is a necessity.

Cannabis Testing laboratories perform a variety of tests, full analysis for production, QA/QC, contract commercial testing, extraction, or purification only, or research. With the legalization of cannabis in Canada and growing acceptance in the US for medicinal and recreational use, testing is becoming a critical component in ensuring product quality. In addition to ISO standards, Good Automated Manufacturing Practices (GAMPs) apply to the manufacture of CBD or THC.

Beginning with sample accessioning and workflow management, LIMS can manage system access along with analysts’ permissions and privileges. This is important, as regulated laboratories are required to provide evidence of the training and competence of the analysts conducting specific tests. Their training records and certifications must be provided and updated as required. The LIMS will track any changes to results in an audit trail, to ensure that the data has not been manipulated, any changes to results (the majority will come directly from the instrument) are documented – the system will hold the original result, the new result, the date and time stamps for each, along with the analyst information and a reason that the result was changed. This process provides a high level of data integrity. The LIMS can also “force” peer review—meaning that the person that entered a result cannot validate and approve that result. These LIMS features help to enforce regulatory compliance with ISO 17025 as well as GALP, (Good Automated Laboratory Practices) and GAMP.

There are so many functions that LIMS can manage and enhance over manual systems, including several that are not directly associated with result data. These include managing chemicals, supplies, and reagents (used in the testing), and their associated expiration dates, lot numbers, CoAs, safety sheets, and vendor information. LIMS organizes sample workflow (with positive ID), result data (along with automated instrument data uploads), also calculations that can be validated and locked. Sensors are commonly used in the laboratory to track temperature, humidity, light, etc. They integrate with the LIMS to meet the requirement for daily temperature monitoring of the incubators, refrigerators, and freezers in the laboratory.

Streamlining laboratory operations (instrument integration, calculations, temperature monitoring, automated alerts for out of specification products) and eliminating mundane tasks is critical to ensuring the production of high-quality data, increasing productivity, maximizing resources, and increasing efficiency, thereby increasing profitability.

Compliance-related considerations for LIMS selection include cost of ownership, deployment (SaaS or premises), technology, features, QA/QC, usability, and security.

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