August 12, 2019
When you are starting a cannabis testing lab, you may already be familiar with the analytical instruments required, the need to hire trained personnel, infrastructure setup, obtaining state and local regulatory approvals, and the testing quality standards that you need to follow. However, selecting an informatics tool, especially a LIMS, may prove to be a challenge owing to the complexities that you expect the LIMS to handle.
So what are the key informatics requirements of a cannabis testing lab? The goal is to offer high-quality analysis and standout for services. You should prioritize the requirements your testing facility should have from a LIMS:
1. Compliance: The first priority should be to meet state and local regulatory compliance. A LIMS should be secure and be able to meet the requirements of internal and external audits.
2. Features: The second priority should be to ease and automate laboratory processes, such as handling high data volumes and multiple test requests, Chain-of-Custody (CoC), seamless input of the sample and test data.
3. Budget: And lastly, but most importantly, it should be affordable with a low payback period. You may want to access the services provided by LIMS vendor, add-on charges for setup and training, their expertise in the market and the ease of use of the product. This step may be an important consideration in finding out the total cost of ownership.
While federal, state, and local governments regulatory frameworks exist for cannabis, standards for cannabis testing are still in flux. Regulations that apply to cannabis labs vary from state to state, but universal standards such as ISO/IEC 17025, 21 CFR Part 11, GLP still apply. Given that your laboratory needs to face audits, it is imperative for your lab to follow these regulatory guidelines and your LIMS should help you meet them.
ISO/IEC 17025 accreditation, an international quality standard for testing and calibration labs, offers proof of quality and competency for cannabis testing laboratories. Growers and manufacturers choose the ISO-certified testing labs for their testing needs since they are assured that an audited quality management system is in place and that the test results generated can be tested. Hence, they do not require to conduct audits of the testing lab, saving time and money.
A LIMS for a cannabis testing lab should include laboratory organization and management structure, document control and management, proper procedures for instrument calibration and maintenance, adherence to testing standards, personnel and training management, searchable and audit trailed records of the entire sample life-cycle, Quality Control and Quality Assurance (QA and QC) in order to meet the ISO/IEC 17025:2017 guidelines.
Keeping a track of legal cannabis from seed-to-sale is critical, and any person involved at any stage of the supply chain is required to report into the tracking system, including persons that produce, test, package, label, send, deliver, transport, sell, or dispose of cannabis. To track, monitor, analyze, and guarantee compliance with complex state regulations governing the growth, distribution, processing, and sale of cannabis products, a LIMS you choose should be able to generate and import the test results to Seed-to-Sale software, such as METRC®, BioTrackTHC®, MJ Freeway, and other state tracking systems.
A LIMS should support sample accessioning, automatic assignment of sample lot ID, Chain-of-Custody (CoC) in order to track every milligram of the sample that enters the lab.
A LIMS should support qualitative and quantitative tests for multiple analytes, such as Tetrahydrocannabinol (THC) and Cannabidiol (CBD), along with microbiological tests like total yeast and mold count, E. coli, Salmonella, among other pathogens. Additionally, it should account for the amount of sample and reagents consumed while performing tests.
A laboratory can eliminate manual entry and avoid transcription errors by using a LIMS that offers seamless integration with lab equipment using CSV file mapping or API integration.
Lab Inventory Management
All reagents, standards, and supplies should be tracked using a LIMS with a lot number, expiration date, current quantity, usage with tests and threshold reorder quantity for receiving alerts when nearing depletion levels.
Services and Billing Management
Supports management of laboratory services such as sample test requests, besides catalog creation with defined pricing for each service offered by your laboratory.
Certificate of Analysis (CoA)
A LIMS should have a robust test validation mechanism and a flexible reporting system for reporting test results in a professional format, along with the laboratory logo, signatures, doughnut charts, graphs and sample images.
Testing laboratory customers need 24/7 access to the test results. A LIMS with a built-in client portal enables your customers to place test requests, access test results in real-time, download Certificates of Analysis (CoA) and invoices. This helps in reducing turnaround time and increasing customer satisfaction.
Given that you have already made an investment in setting up a facility, you need to choose a LIMS that is light on your pocket, or in other words, has a 6 month to a year’s payback period.
You should choose a LIMS that offers configuration functionality rather than customization since most LIMS vendors charge heavily for customization of their products. However, the configuration is not chargeable.
An important aspect to consider is the complementary services offered by the vendor. If there are additional costs for product hosting, initial setup, configuration, data migration, the total cost of ownership increases significantly.
A LIMS manages SOPs, test methods, access privileges, regulatory requirements, web access, and many other operational procedures. It is a LIMS that assures the quality of the data being produced and therefore affects the reputation of the cannabis testing laboratory. A purpose-built cannabis testing LIMS can transform your laboratory operations, reduce costs, and maximize income streams.
Metrc is a trademark of Franwell. BioTrackTHC is a trademark of Bio-Tech Medical Software, Inc.