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As more and more laboratories gear up to perform cannabis testing services, it is critical to be able to differentiate between those that provide high-quality analyses and those that do not perform as well. A laboratory information management system (LIMS) can make all the difference. Simply put, a LIMS is a software system developed to support all operations within the laboratory, from the handling and storage of samples, to the performance of the analytical tests, to the reporting of results.
An explosion of information
Each year, as regulatory requirements evolve, there is a need to manage and maintain a continually growing quantity of data. The following is an overview of the scope of the information that must be managed:
- A laboratory must maintain a chain-of-custody for all samples (controlled substances) it receives. This requires tracking the movement of the sample within the laboratory. For example, when a controlled substance is received, it must be identified, weighed, and managed in terms of how much is used in the analysis, where it is stored, and who handles it and under what conditions, etc. Additionally, samples are often split—for example, a subsample or aliquot might be sent to the chemistry department and the other part of the sample to the microbiology department—so chain-of-custody must be maintained for subsamples as well. Laboratories also need to track samples that have not been analyzed and catalog their disposal. Samples are stored in a secure location and the LIMS inventory management functionality provides complete traceability.
- All completed analytical tests must be recorded along with any QC performed, as well as all reagents used in the testing (along with vendor, lot number, and expiration date); this allows the laboratory to quickly identify affected test results in the event of a recall of reagents or standards.
- All refrigerators, freezers, and incubators must have a temperature log that documents the daily temperatures to ensure the proper storage environment is upheld.
- Clients that submit samples must provide such information as the quote they were provided, billing address, address to which the report should be sent, and contact information.
- All equipment used in the laboratory must be managed, maintained, calibrated, and tracked.
- All chemicals, reagents, standards, and supplies must be accounted for, with lot number recorded, along with the expiration date, quantity on hand, and Safety Data Sheets.
ISO compliance
ISO certification offers undeniable proof of quality, and is important for cannabis testing laboratories. Most professionals will seek an ISO-certified vendor to ensure that an audited quality management system is in place, so that the laboratory does not have to conduct its own audits of the vendor, saving time and money.
A proven system impacts the day-to-day management of the laboratory, from sample accessioning, sample management (internal chain-of-custody), to streamlined data entry. In addition to meeting regulatory compliance requirements, most laboratories will have automated data import from instruments; electronically import subcontracted laboratory data; and have easy internal data review and approval, QA/QC, and an audit trail through final reporting, disposal, and invoicing.
There is currently a push toward ISO 17025:2017 compliance, an international quality standard that ensures the laboratory has a quality management system. ISO 17025:2017 is based on the ISO 17025 Standard, and requires a regulatory audit by an external ISO-certified auditor. Laboratories that obtain this certification and work with other ISO-certified vendors will differentiate their laboratories from those that lack this certification.
Reporting of final results
Since the final product of the laboratory is data, it is critical to protect and store it within a secure database, with a robust audit trail that documents any changes to the result. Results are frequently time-critical, so the laboratory that can deliver this information in a concise, efficient, user-friendly way (i.e., easy-to-read reports) will have a competitive advantage.
In addition, clients want 24/7 access to results. Along with automated e-mail pdf reporting, the best laboratories provide a secure web portal that offers real-time data on the status of the testing, as well as preliminary and approved results. Clients have the ability to download and print their reports and invoices or access the data electronically.
The most common tests performed on cannabis are for potency, terpenes, contamination (physical or microbiological, primarily bacteria and mold), and residual solvents. It is critical that these characteristics are analyzed and reported in order to ensure consumer safety. In addition, accurate and comprehensive test results will result in a higher market value of the final product.
As well as acquiring the necessary analytical instrumentation, setting up the laboratory infrastructure, hiring highly trained analysts, and obtaining the required licenses, it is advisable for a new cannabis testing laboratory to implement an easy-to-use LIMS. LIMS provides security from the moment the sample arrives in the laboratory through final reporting and disposal—fundamental to a successful cannabis laboratory. All testing is documented in the LIMS, along with the parameters that are tested and the corresponding test methods or SOPs (Standard Operating Procedures). The system also manages all paperwork received by the laboratory, which is typically converted to a pdf and linked to the job or work order.
In addition to providing centralized, secure storage of the data to facilitate better communication within the organization, the LIMS also manages all data in the laboratory. This additional information supports the quality of the result, such as ensuring that reagents and supplies are not expired, incubators and freezers are at the proper temperature, instruments have been calibrated, and employees have received the proper training. A LIMS is also vital in ensuring compliance with international quality standards as well as designing and implementing lean workflows. Figure 1 depicts a high-level overview of the information that is managed by the LIMS.
Figure 1 – Integrated LIMS solution.LIMS features and functions
For laboratories to be cost-effective, they need to identify potential bottlenecks and examine the key workflows to promote lean processes, thus maximizing resources. A LIMS provides cannabis testing laboratories with the following key features and functions:
- Sample tracking along with:
- Internal chain-of-custody (so that all product can be accounted for)
- Positive ID (RFID, 1-D, and 2-D barcoding) from login to final disposition
- Quoting and invoicing
- Data entry—either manual or uploaded from the analytical instrumentation
- QA/QC
- Stability testing to examine potency over time
- Ability to track raw materials, from seed through final distribution
- Chemical and supply inventory
- Document management—online SOPs, method versioning, linked manuals, and related documentation
- Resource management (instrument records and manuals and employee training records)
- Electronic data transfer: instrument integration to eliminate transcription errors and accelerate data acquisition
- Enterprise integration with key business and operational solutions such as accounting and ERP (enterprise resource planning)
- Automated reporting via e-mail or export to a web portal
- Integrated web portal for 24/7 result access, locked pdf report downloads, and sample submission
- METRC (Marijuana Enforcement Tracking Reporting Compliance Integration, www.metrc.com)—a regulatory program that currently supports 10 states and the District of Columbia
- Integration with hundreds of other industry-supporting solutions for seamless accounting, such as seed-to-sale software packages, dispensary software, and ERP, for efficient data transfer.
Figure 2 is a sample of what might be included in a report from a cannabis testing laboratory.
Figure 2 – Sample report template with fabricated data to demonstrate the various parameters that can be reported.Conclusion
In addition to handling the infrastructure controls, LIMS manages SOPs, methods, metrology data, permissions, privileges, regulatory requirements, web access, and many other operational procedures that ensure high-quality data is being produced. Ultimately, LIMS protects the brand of cannabis testing laboratories.
Dr. Christine Paszko, MT (ASCP), Ph.D., is vice president, Sales and Marketing, Accelerated Technology Laboratories, Inc., 496 Holly Grove School Rd., West End, NC 27376, U.S.A.; tel.: 910-673-8165; e-mail: [email protected]; www.atlab.com