| Table 2. What a purposeful cannabis testing LIMS will address for a lab
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| Cannabis testing need
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Details
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| Configurable sample registration screens optimized for the cannabis testing industry
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Even though some LIMS already provide the ability for users to define their own sample registration screens and fields, it doesn't necessarily mean the vendor will also include pre-loaded screens and preferences for a specific industry or scientific discipline. Those vendors tailoring sample registration screens and preferences specifically to cannabis testing lab requirements for launch-day deployment have a step up on other LIMS vendors.
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| Pre-loaded cannabis testing protocols, labels, and analytical reports
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End users of a cannabis testing LIMS will appreciate having a wide array of pre-loaded testing protocols, label templates, and report templates that support the testing of acid and neutral forms of cannabinoids, potency, strain, water activity, moisture content, pesticides, solvents, heavy metals, microbiological contaminates, fungi, mycotoxins, and foreign matter. This includes the ability to configure measurement units, as well as customize analytical reports such as certificates of analysis (COAs) for multiple state- and locally regulated testing scenarios.
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| Support for the creation and management of additional protocols, labels, and analytical reports
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As with pre-loaded protocols, labels, and analytical reports, providing users the ability to create and manage their own protocols, labels, and reports—including COAs—as the industry changes is critical.
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| Flexible specification limit sets for quality control
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A vital component of testing protocols that should not be overlooked is how flexible their test parameter/specification limit sets are. As regulations and standards concerning cannabis testing—across many different substrates/matrices—may change rapidly at the federal, state, and local level, adjustments to the limits declared within testing protocols must be easy to make. Additionally, the system should be capable of retaining older historic limit sets, such that past results can later be accurately linked to their original limit sets.[4] These limit sets can help improve quality control and the reporting of out-of-specification (OOS) samples and results.
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| Third-party system integration, with strong support for APIs for track-and-trace and other legally mandated reporting systems
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Seed-to-sale systems, like METRC, or other types of government-mandated reporting systems may have a web-based user interface (webUI) for manual entry of results data, or they may even support a .csv upload of data. However, manual entry of results can be time consuming and result in a higher likelihood of errors. As such, the more efficient way to report data to those types of systems is through more automated means, connecting your LIMS with a web-based application programming interface (API), typically provided by the vendor of the seed-to-sale or reporting software. This means the LIMS must either be pre-configured to connect with all the necessary APIs or be equipped to handle connection with any API.
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| Instrument integration with the instrument data systems common to cannabis testing
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From mass spectrometers and chromatography equipment to quantitative polymerase chain reaction (qPCR) systems and moisture balances, being able to accurately and securely transfer analytical data automatically improves turnaround time (TAT) and better ensures the accuracy of entered results (versus manual data entry). This is particularly important in the highly regulated industry that is cannabis testing.
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| Granular chain-of-custody at every step
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A seed-to-sale or "track-and-trace" system means always knowing the who, what, where, when, and how much of cannabis materials and related products in the industry life cycle. This concept is often referred to as the "chain of custody" of cannabis related material. This chain of custody is not limited to received cannabis samples, either; it also includes any subsamples and aliquots generated in the testing laboratory, as well as any disposed materials. As such, it's vital the LIMS be able to accurately document the chain of steps that received cannabis materials go through, from reception and retention to delivery and destruction.
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| Inventory reconciliation, including sample weight reconciliation
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Related to the "how much" of chain-of-custody tracking, sample weight reconciliation is an important element of avoiding regulatory violations.[5] The LIMS should be able to either automatically deduct sample and inventory quantities when consumed as part of a test (including subsamples and aliquots), or it should allow manual entry of such changes with background validation checks or warnings. For example, the system would need to clearly warn the user when attempting to pull more weight from a sample than exists, which would create a negative value.
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| Real-time alerts and issue tracking
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The requirement for maintaining quality testing outcomes for consumer safety and client satisfaction drives the need for prompt real-time alerts. Users must clearly and promptly be notified of errors and OOS results (via limit sets and other triggers) in order to, for example, identify health risks associated with a tested product or discover mislabeled product. These OOS results, as well as any other problems, should be tracked not only to notify clients but also to guide corrective action. Alerts and issue tracking are also useful for ensuring scheduled tasks are completed before they are due, or correcting processes if tests inadvertently become overdue.
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| Capacity and performance monitoring
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Whether an R&D cannabis lab or a quality assurance lab for cannabis, monitoring workloads, instrument allocations, scheduled tasks, OOS results, and any lab-specific performance indicators is vital for ensuring quick turnaround time (TAT), accurate results, productive workflows, and positive regulatory outcomes. Similar to issue tracking, capacity and performance tracking also help maintain quality testing outcomes and client satisfaction. Custom key performance measure (KPM) creation and management is also useful towards those efforts.
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| Strong data security and confidentiality
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When it comes to cannabis and protected health information (PHI), dispensaries are the most likely to require careful attention to consumer information.[6][7] However, that does not preclude laboratories from making strong efforts to protect sensitive personal data related to clients and their analyses (let alone to protect the lab's own validated methods and documentation). As such, cannabis testing labs should rely on a LIMS that uses industry-standard communication protocols and encryption methods to protect not only the data housed in the LIMS but also data moving in and out of it.
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| Accounting and billing support, including quoting and invoicing
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Carefully tracking expenditures and payments received related to cannabis activities is vital. This is especially true given that the non-hemp (low-THC) Cannabis plant is still technically illegal to grow and process in the eyes of U.S. federal law. As such, some business taking in money from cannabis-related activities have had problems with managing the financial aspects of their operations.[8][9][10][11] Given the remaining uncertainty of cannabis legalization in the U.S., and the natural benefits of managing accounting and billing within the LIMS, it makes sense that a LIMS should be able to accurately track receipts and more, down to the penny.
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| Secure web portal for client results review and test ordering
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Clients appreciate being able to submit test orders and view the results of their tests on a relatively independent basis. The secure web portal makes a useful time-saving and customer-friendly tool in that effort. However, the "secure" part of this requirement must be emphasized. Web-based attacks remain some of the most popular cybersecurity attacks, targeting the likes of online customer portals and WordPress sites for credentials and sensitive information.[12][13] As indicated previously, a vendor that focuses on strong data security will have an advantage in the implementation of such a web portal.
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| Functionality supporting ISO/IEC 17025, NELAC, ORELAP, ELAP, and Patient Focused Certification (PFC) compliance
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Cannabis testing laboratories and their necessary focus on quality is driven by standards and regulations, as well as accreditation to those standards and regulations. That burden can at times be heavy for laboratories, so having automation elements like a LIMS that provides functionality that assists with complying with those standards and regulations is immensely helpful. For example, ISO/IEC 17025 has a requirement that documents be managed in a specific way, an area where a well-designed LIMS is able to help.
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