Agriculture

Features and Functions in a Cannabis Testing LIMS

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Far and away the most important feature in a cannabis testing LIMS is that it support the full range of testing required. That means results from HPLCs and GCs (potency/cannabinoids, residual solvents, pesticides, mycotoxins), GC/MS (terpenes), LC/MS (pesticides), MS (residuals, water), ICP and AA (heavy metals), microbiology (molds/fungus, other organic contaminants) and genetic testing. To clarify, here are the tests a cannabis lab must be performing in order to be commercially viable, whether in the recreational or medicinal market:

Cannabis Laboratory Tests

  • Potency
  • Terpenes
  • Strain (terpene/cannabinoid ratios)
  • Residual solvents
  • Pesticides
  • Heavy metals
  • Water activity
  • Moisture Content
  • Foreign materials
  • Mold and microbiological contaminants[1][2][3][4]

Regs and Standards

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It's true that most states have no regulatory or standards requirements of labs, but those who have chosen to take advantage of that by offering fake certifications or poorly-executed and inaccurate results have found that the negative consequences far outweigh the benefits of that strategy.[5][6][7][8][9][10][11][12]

So states are fast realizing the need to adopt quality requirements for labs, and where that still remains a ways in the future, most labs are making their own decisions to attain ISO 17025, GLP/GALP and similar certifications, including new ones aimed at the cannabis industry specifically, like ASA (Americans for Safe Access) and PFC (Patient Focused Accreditation) in order to (a) compete successfully and (b) anticipate future requirements. This obviously has impact on requirements for the LIMS software used to manage testing data. To be a maximum value proposition, it must support these types of standards and certifications - as well as being capable of helping you meet any new regulations brought in by the state. That means that by design it needs to be secure and accurate, with control over user access, as well as being user-configurable so that it is flexible enough to support any new requirements that come along without having to pay for new coding/development.

For more detailed information on regulations and standards in the cannabis industry, see Regulatory Compliance Considerations.

Cannabis Testing Processes/Workflows

There are three main attributes a LIMS must contribute to laboratory process workflows:

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1. Automation/streamlining - One of the chief advantages a LIMS brings to the lab workflow is the automatic updating of process step statuses, so that it is instantly apparent to authorized users or supervisory personnel how far along any sample or set of samples is at any given time. Similarly, it should prevent status changes until the previous status has been fully completed. Furthermore, it should enforce the assigned order in which each step or process must be performed for any given method, and any required restrictions on who should carry them out (alternating analysts, named analysts, etc.). Additionally, any QC samples, matrices, catalysts or other prep or analysis components can be mandated so that methods are followed correctly, QC/QA requirements are met and all are automatically documented for easy recall during audits. Once all tests for a particular sample or order are complete, the report or COA should be immediately available. Overall, the workflow is thus made to be as speedy, complete and properly performed as possible.

2. Data Accuracy and Security - Another important aspect of LIMS-managed workflow is control of who has access to each process, test result, etc., and, if the LIMS is integrated with the instruments, then results transcription errors are eliminated as well. An Audit Trail function should ensure user interactions are documented, along with any results changes, the reason for the change, old and new values and date/time stamp. Encryption, coupled with access security, data protection methods (e.g. firewall, backups, redundancy) provide much greater security than paper folders and files or even spreadsheets, etc.

3. Flexibility - Given the evolving nature of the cannabis industry, as well as the consideration that the ability to diversify a lab's testing services can be an important factor in its success (see Evaluating and Implementing a LIMS for Cannabis Testing, the abilities to make new versions of tests with different limit sets, create producer or strain-specific sets of specifications to test to, make entirely new tests, etc. - all without having to resort to enlisting developer services - is a very desirable and valuable characteristic in a LIMS. It means a longer life expectancy for the software, which means greater return on your investment, and can mean the difference between adapting to market demands and surviving/prospering, or inability to afford development in tough times and failing due to non-competitiveness.

Sample Submission

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Labs receive samples either on an ad hoc basis, regularly scheduled (production QA/QC, for example) or both. The LIMS should support each, allowing samples to be created before they are received (either manually or according to a schedule), with the ability to indicate when they have actually been received, and are then available for testing. The logging and receipt procedures should auto-populate where possible (repeat submitters, etc.) and aid speedy entry. Features that help include auto-complete typing, drop-down picklists, intelligent auto-populating (e.g. certain tests are appropriate for certain sample types, so the system filters the ones it displays as available), etc. Samples should be automatically assigned a unique ID in the system.

An additional feature that greatly enhances competitiveness is the ability to accept test requests via web portal. Submitters can enter information about their sample(s) and themselves and request the tests they want and even pre-pay if desired. The portal is secure and private for each user's own data, and also allows them to view the status of their submissions, as well as the final COA or report. There will probably be costs associated with the setup/configuration of the portal, but it should be an available feature of the LIMS without requiring that it be specially developed.

The LIMS should also allow you to print (barcoded/RFID) labels automatically when samples are received, or manually at any time (you should be able to configure the labels to suit).

Batching, Reviews, Flexibility and More

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Some characteristics of effective workflow supported by the LIMS include quick and easy batching of samples by process step, e.g. all samples that are ready for a particular prep or extraction, instrument analysis, review, etc. Review steps, in fact, are another feature your canna LIMS should easily support. You should be able to mandate - either automatically or on the fly - as many review/approval steps as desired, and specify individuals or roles allowed to complete them, and have the system fully document them. In fact, this configurable property allowing you to build workflows is an essential one, tied to the overall flexibility that even a LIMS designed specifically for cannabis labs should have.

The system should track samples from initial submission to return, permanent storage or disposal, and document it all to meet audit requirements, providing full Chain of Custody (COC) functions and documentation.

Tests should be able to be assigned automatically by sample type, client or other criteria, as well as specification limit sets, and the LIMS should provide alerts/notifications where these are violated. Simple "click for re-run, approve or cancel" functionality should allow results to be processed speedily and accurately.

Reporting

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The final product of any lab, including a cannabis testing lab, is the report. In most cases this is a COA (Certificate of Analysis). The LIMS should have a standard COA template based on the standard cannabis tests, configurable to include your lab's logo, contact details and any other information, disclaimers, etc. you want to include. That means it probably has its own (or a bundled generic) report writer app, that allows you to also design and implement other types of reports if/when you want.

That's the minimum requirement. But of course you also need to keep track of your lab's internal metrics - TAT (Turnaround Time), # samples processed (weekly/monthly/yearly), backlog/outstanding work, etc. And you (justifiably) expect a LIMS to offer those kinds of reports too - as well as the ability to print out a bench worksheet for manual data gathering if needed.

The other key reporting feature your cannabis LIMS should offer is QC control charting, showing historical results as measured against control parameters. And this also relates to another feature you may want to include: the ability to data mine, e.g. call up all historical results for a product for a given time frame to map variances over time. Both of these should be in a format that allows export to a full-featured charting/visualization app (Excel, .csv., .txt).

Additional Features

The above features and functions are the essential ones you'll want for a genuine value-add LIMS. But most offer additional capabilities, and you can ask to see how they would help you, and figure them into your budget if they are important to you. Some of these include:

  • Training & Certification Management
  • Instrument Maintenance & Calibration Management
  • Inventory Management
  • Integration - instruments, applications, databases, online exchanges, directories, tracking/reporting systems (METRC, BioTrackTHC)
  • Invoicing
  • Manual/auto alerts, email notifications
  • Tablet/mobile-friendly
  • Additional business/productivity apps comprising holistic solution

Summary

So basically you need a LIMS that is

  • Stable and proven
  • "Tuned" for cannabis testing
  • Easy to use, intuitive and speedy
  • Ensures accuracy, security and compliance
  • Competitive in features and pricing - best VALUE (benefits/price) while providing everything needed
  • Not a nightmare to implement

The information and tips provided here should help you to make good decisions in evaluating and implementing a LIMS for your cannabis testing laboratory. If you are starting up a new lab, see Starting a Cannabis Testing Lab for some guidance on getting going in the fast-growing cannabis industry.

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References

  1. "QC Testing - What Do We Test For?". QCL Quality Compliance Laboratories. http://www.qctest.com/qc_testing.php. Retrieved March 22, 2017. 
  2. "Services". CB Labs. http://www.cblabstesting.com/services. Retrieved March 22, 2017. 
  3. "Cannabis Testing". OG Analytical. http://oganalytical.com/services/cannabis-testing. Retrieved March 22, 2017. 
  4. "Cannabis Testing Methods". GenTech. http://gentechscientific.com/cannabis-testing/cannabis-methods.php. Retrieved March 22, 2017. 
  5. Grant Robertson and Greg McArthur (August 12, 2016). "Investigation: What's In Your Weed?". The Globe and Mail. http://www.theglobeandmail.com/news/investigations/globe-investigation-whats-in-your-weed-we-tested-dispensary-marijuana-to-findout/article31144496. Retrieved March 22, 2017. 
  6. Laura Cassiday (October, 2016). "The Highs and Lows of Cannabis Testing". AOCS. https://www.aocs.org/stay-informed/read-inform/featured-articles/the-highs-and-lows-of-cannabis-testing-october-2016. Retrieved March 22, 2017. 
  7. Rambo (July 21, 2013). "Is Cannabis Lab Testing a Scam". Marijuana Growers Headquarters. http://marijuanagrowershq.com/is-cannabis-lab-testing-a-scam. Retrieved March 22, 2017. 
  8. Evan Bush (February 18, 2015). "World’s strongest weed? Potency testing challenged". The Seattle Times. http://www.seattletimes.com/seattle-news/worldrsquos-strongest-weed-potency-testing-challenged. Retrieved March 22, 2017. 
  9. Amanda Chicago Lewis (April 30, 2015). "Wax Is Weed’s Next Big Thing And No One Knows If It’s Safe". BuzzFeed. https://www.buzzfeed.com/amandachicagolewis/is-hash-oil-safe?utm_term=.qad6y2vaYJ#.kt3zedY604. Retrieved March 22, 2017. 
  10. Mike Adams (March 17, 2017). "The Quality Of Government Marijuana Is So Bad It’s Hindering Research". The Fresh Toast. https://thefreshtoast.com/cannabis/the-quality-of-government-marijuana-is-so-bad-its-hindering-research. Retrieved March 22, 2017. 
  11. Gregory Frye (December 22, 2015). "The Unfortunate Truth about Cannabis Lab Testing". Green Flower. https://www.learngreenflower.com/articles/67/the-unfortunate-truth-about-cannabis-lab-testing-2015-12. Retrieved March 22, 2017. 
  12. Caleb Hellerman (March 8, 2017). "Scientists say the government’s only pot farm has moldy samples — and no federal testing standards". PBS.org. http://www.pbs.org/newshour/updates/scientists-say-governments-pot-farm-moldy-samples-no-guidelines/. Retrieved March 22, 2017.