February 14, 2019
Automation of the laboratory workflows is the need of the hour. According to a recent survey conducted by the Astrix Technology Group, about 90% of the companies with R&D laboratories have switched to a Laboratory Information Management System (LIMS) to automate their laboratory workflows. When a large number of clinical, pharmaceutical, diagnostic, and other labs are shifting their workflow automation towards a LIMS, why are we only talking about automating cannabis testing laboratories? Are there any cannabis industry-specific challenges that need to be addressed by switching to a cannabis LIMS? The answer is definitely, yes.
Laboratory testing of cannabis is one of the most important elements in the cannabis marketplace and must be standardized, consistent, and robust to ensure long-term growth of the cannabis industry. In a relatively short time span, cannabis testing laboratories have developed a reasonably standard set of tests and methods. Cannabis laboratories conduct tests to determine levels of cannabinoid, pesticide, terpenes, heavy metals, fungi, molds, moisture content, etc. These types of tests, when separated into individual analytes and metabolites, include over 750 constituents. The basic laboratory operations are similar to other testing laboratories wherein, the tests are ordered by customers, cannabis samples are received, processed, quantitative and qualitative tests are performed, results are validated and approved by a laboratory manager, and finally the Certificate of Analysis (CoA) is sent to the customer. Although most of the activities are similar to other testing laboratories, here are some of the challenges that are critical and specific to the cannabis industry:
Challenge #1: Analyzing Cannabis can be Challenging: It is mandatory for laboratories testing controlled substances to maintain a strict account of each gram of sample, right from its reception, consumption for testing to sales and disposal. Since samples are often used for multi-analyte testing, the workflow often involves the transfer of samples and tests from one custodian to another within the testing facility. Hence, it is crucial to maintain a Chain of Custody (CoC) to track the transfer and disposition of a sample from one analyst to another.
Challenge #2: Growing Legalization of Cannabis: Another challenge of cannabis testing laboratories is the growing need for legalization and stricter enforcement of policies on cannabis testing. The legalization of cannabis has resulted in the expansion of this industry at a very fast pace, resulting in more stringent local and state regulations that stretch right from the cannabis cultivators to the dispensaries. The use of cannabis in therapeutics is evolving, finding new application areas. With the state-led legalization of cannabis, an increase in the number of test requests is observed from cannabis cultivators to determine the quantitative and qualitative properties of the produce. When the volume of tests performed by each lab increases, it becomes necessary for these laboratories to automate their laboratory workflows to ensure efficient management of resources and assure accuracy. Furthermore, automation helps cannabis testing laboratories ensure proper quality assurance, regulatory compliance, and several other aspects of data management that are vital to staying competitive in the market.
Challenge #3: Accreditation and Regulatory Compliance: Cannabis testing laboratories are subject to several regulatory compliance requirements, accreditation standards, laboratory practices and policies. Proper execution of the regulatory protocols throughout the testing process is necessary to ensure the smooth functioning of laboratories and the accuracy of analytical data. The most important standard that every cannabis testing laboratory should follow is the ISO/IEC 17025: 2017, which sets the requirements of quality standards in these laboratories.
Challenge #4: Quality Assurance, Standards & Proficiency Testing: QC control charting is an indispensable step for the cannabis testing laboratories to compare and plot the results against the control parameters. To comply with the 21 CFR Part 11 guidelines, a LIMS should have the ability to delineate user permissions for every QA/QC step. Additionally, it is necessary for the cannabis testing laboratories to participate in appropriate and commercially available Proficiency Test Programs or Inter-Laboratory Comparison Studies. This enables them to compare their analytical performance with other testing laboratories. It is imperative for cannabis testing laboratories to automate their laboratory workflows for efficient management of analysis, tracking, and reporting of test results. This can be seamlessly achieved by means of a robust LIMS. Switching to a LIMS can help cannabis testing laboratories to manage customer and analytical data appropriately, and to provide accurate, scientifically valid test reports to customers and regulatory authorities.
Gathering, organizing, and managing analytical data are time-consuming, labor-intensive and challenging tasks for any cannabis testing laboratory. Managing data with spreadsheets and paper-based methods makes the system error-prone, cumbersome, costly, and inefficient. This further makes it difficult for these laboratories to retrieve the data and to comply with the regulatory guidelines. One way to overcome this challenge and to eliminate other mundane tasks that use human resources is to switch to a LIMS purpose-built for cannabis testing laboratories. Is a cannabis LIMS different from an all-purpose LIMS? The answer is yes, again. Owing to the constantly evolving nature of the cannabis industry, a cannabis LIMS should be scalable enough to meet the ever-changing business needs. Therefore, it is necessary for a cannabis LIMS to include certain additional features compared to a generic LIMS. Some of the features that should be present in a cannabis LIMS include:
1. Ability to track and differentiate between recreational and medical cannabis.
2. Optimized and configurable test protocols, labels, and reports should be pre-loaded. This helps to quickly assign tests for the incoming cannabis samples.
3. An API to integrate with state-required compliance reporting systems.
4. Maintain a complete CoC to track samples from “cradle to grave”.
5. Should enable real-time access to laboratory work status to enhance communication within a laboratory, between a laboratory and its clients, and across a global organization with multiple sites.
6. Comply with the regulatory standards by recording comprehensive audit logs for laboratory activities along with a date and time stamp. It should also help laboratories follow 21 CFR Part 11 and ISO/IEC 17025:2017 standards.
7. Ability to send data/reports/invoices to customers via a web portal.
8. Ability to print labels and barcodes.
9. Complete, automated QA/QC protocol management.
10. Package and shipment management.
11. Should be easily configurable.
A cannabis LIMS facilitates comprehensive and reliable cannabis testing to ensure consumer safety. It helps to reduce manual workloads and enhance laboratory productivity while achieving regulatory compliance with ease. Automation of cannabis testing laboratory workflows improves the quality, efficiency, the accuracy of services, and reduces turnaround time with significant cost savings. This helps cannabis testing laboratories to adapt to the growing market demands and attain a greater return on investment. Thus, a cannabis LIMS helps to grow the business by supporting the data management needs and the need to navigate according to the changing regulatory environment of cannabis.