July 06, 2017
Today, 89 percent of the Americans support cannabis for medicinal use and 25 states have already legalized medical cannabis. In addition, cannabis is also being legalized in several states for recreational use. It, thus, seems almost certain that we will see an acclivitous surge in the demand for cannabis testing facilities and laboratory services.
With the increasing demand for cannabis testing, the existing testing labs and the ones that are on the verge of being operational will open up to incremental test requests for cannabinoid levels, pesticide levels, terpenes, moisture, heavy metals, fungi, molds, and more. Considering the magnitude of testing, data management using spreadsheets is a serious impediment to the quality assurance in cannabis testing labs, since it is error prone and makes data retrieval difficult.
Laboratory informatics solutions such as Laboratory Information Management System (LIMS) can help track samples, manage workflows, record test data and drive compliance. With a LIMS in place, cannabis testing laboratories can automate cannabis testing workflows right from sample collection, data capturing, maintaining chain of custody for the tests performed, accounting for sample weight losses, to generating reports. Each and every progressive step in the testing workflow can be recorded along with the date and time stamp. Such audit trails help monitor and maintain a quality system by providing traceable documentary evidence—required to achieve ISO 17025 accreditation—for highly regulated cannabis testing laboratories. LIMS also supports role-based data security. Every user of the system has unique login credentials and leaves a digital signature for every action performed in the system. Users can be assigned specific access privileges by the master administrator based on the user's role in the lab, thereby ensuring structured data and process management.
In cannabis testing labs, the quality of data management tools such as MS Excel sheets and other software is further put to test against stringent regulatory guidelines. This is attributed to the fact that the compliance norms demand accounting for every unit of the sample involved in testing—right from reception, through consumption for tests, to its sale and disposal. With a LIMS implementation, the sample weights are automatically calculated as per the testing workflows. Thereby, such automated laboratory workflows support sample traceability, following state and local laws.
It is imperative for testing labs to maintain the chain of custody. Chain of custody records the comprehensive disposition of a sample by documenting the personnel involved in collection and handling for test analysis. Such a workflow is said to withstand a regular court scrutiny. Within a lab, the transfer of tests from one user to another automatically generates a Test-Chain of Custody (Test-CoC) with electronic signatures and reasons for the transfer. The recipient user gets notified either through an auto-generated email or by viewing an entry in the notifications list in the LIMS.
LIMS automatically maintains electronic records of incidents, corrective actions, non-conforming results, and other activities and makes them available for viewing and reporting. This continual monitoring of the lab’s data helps minimize errors and identify potential areas of improvement. Furthermore, the generation of the Certificate of Analysis and batch variance report—an important requirement for many cannabis testing labs—is made easy with automation.
The state compliance systems are also offering APIs to integrate LIMS for achieving regulatory compliance with ease. Eventually, LIMS would be a compulsory requirement in meeting state regulations for accredited labs, weighing the hard and fast scrutiny of cannabis supply to the public.