Leveraging LIMS to Achieve Regulatory Compliance for the Cannabis Testing Laboratory

Most Cannabis testing laboratories perform a variety of tests, full analysis for production QA/QC, and contract commercial testing, while others focus on extraction or purification only, or research. With the legalization of Cannabis in Canada, and growing acceptance in the US for medicinal as well as recreational use, testing is becoming a critical component in ensuring product quality.  ISO 17025 Certification is a requirement for Cannabis testing laboratories, along with many other state and federal requirements. Other organizations that are manufacturing products such as CBD or THC also need to understand and comply with Good Automated Manufacturing Practices (GAMP). In order to effectively manage the increasing volume of data and information, Laboratory Information Management Systems (LIMS) are a necessity. 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 that are performing the analysis for 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) will be 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. This means that the person that entered a result cannot be the person that validates and approves that result. Many of these LIMS features help to enforce regulatory compliance with ISO 17025 as well as other GALP (Good Automated Laboratory Practices) and GAMP requirements. There are so many functions that LIMS can manage and enhance over manual systems; many that are not directly associated with result data. These includes managing chemicals, supplies, and reagents (used in the testing), and their associated expiration dates, lot numbers, CoAs, safety sheets and along with vendor information. LIMS not only organize sample workflow (with positive ID) and result data (along with automated instrument data uploads), but also calculations that can be validated and locked. This presentation will also examine the growing use of sensors in the laboratory for temperature, humidity, light, etc. and will highlight the integration with the LIMS for meeting 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 are critical to ensuring the production of high-quality data, improving productivity, maximizing resources, and increasing efficiency, thereby increasing profitability.

Learning Objectives:

1. Learning key LIMS functionality which can be expanded with automation

2. Understanding key ISO regulatory requirements that Cannabis laboratories face

3. Gaining insight into how automation and LIMS can help Cannabis laboratories to achieve compliance