RefWork:LIMSpec for Cannabis Testing/Putting LIMSpec for Cannabis Testing to use

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Putting those requirements to practical use

Requirements Allocation Sheet.jpg
Heavily based on the existing LIMSpec on LIMSwiki, this LIMSpec for Cannabis Testing covers laboratory informatics requirements for a cannabis testing laboratory. The requirements are organized into five broad categories, which are heavily influenced by the functional requirements checklist and Figure 3 of ASTM E1578-18 Standard Guide for Laboratory Informatics. However, the requirements listed prior are all based on not just the ASTM E1578 standard but also a wide variety of other standards, regulations, guidance documents, and standardized procedures (here on out referred to as "sources"). That ultimately means a foundational reasoning is provided for almost every requirement, not necessarily a "just because I want it" reasoning. However, as described in Chapter 1, the cannabis testing laboratory has a few specific requirements. As it turns out, many of those requirements—e.g., third-party system integration—are already baked into the original LIMSpec. Yet a few are not, and those requirements—typically not supported by an existing standard or regulation—have been added. In total, all these requirements provide an excellent starting point for building your own software requirements specification or for researching the best laboratory informatics solution for your cannabis testing laboratory. After all, not all informatics systems are equal, and that includes the various offerings of cannabis testing laboratory information management system (LIMS) vendors.

Software developer considerations

What does that mean for you? How can you best use this document? If you're a software developer for the cannabis testing industry, many of the sources referenced in these requirements should already be familiar to you. However, some of them may not be, and you'll probably want to at least familiarize yourself with them. Definitely review the requirements items listed throughout the entire document and make sure they are part of your own software requirements specification. In a few rare cases, a requirement may not make sense for your offering, and that's likely OK, as long as the requirement isn't regulatory-driven. How your business chooses to implement the resulting software requirements is also up to your business. However, keep software development standards and internal quality control in mind.

Buyer considerations

If you're a potential buyer of a cannabis testing informatics solution, this LIMSpec for Cannabis Testing is also useful to you. Perhaps you know a bit about your laboratory's workflow and a few of the regulations and standards that influence how that workflow is conducted, but you're not entirely informed. Reviewing the five broad categories of requirements may be necessary to help further inform you regarding what's vital in regards to what a laboratory informatics solution should be capable of. Additionally, you can then use these requirements as a base for your laboratory's own requirements list.

After reviewing all the various requirements, you can then add those requirements that are unique to your laboratory and industry that are not sufficiently covered by this specification. However, do read the wording carefully, and especially be familiarized with Chapter 1 and its take on requirements specific to cannabis testing; it will map those industry-specific requirements to existing LIMSpec items. As you review the various requirement options available to you and narrow down your own needs, your list of requirements can be used as both a personal checklist and as a requirements list you hand over to the vendor you query.

Software vendor selection

That said, the requirements you hand off to the vendor should be discussed a bit more. Software vendor selection can at times be a tedious yet necessary process, one which requires careful planning and best practices. This topic has been written about by both software developers and end users alike, and their experiences should play a role in how you select a vendor. What follows is bullet-pointed advice as offered by some of those developers and end users.[1][2][3][4][5][6][7][dead link]][8]

  • Have a clear business case and build your business needs into your laboratory's requirements.
  • Be mindful of how detailed you get with your own business-based requirements and what you initially hand off to a vendor. If you're too specific with too many requirements, you may have trouble finding a vendor that matches up. Start with the essentials that involve your laboratory's processes, regulations, integrations, reporting, service needs, etc. As this cannabis testing LIMSpec is foundation-based, you have a good starting point in that regard. You can always get more detailed with requirements as you narrow down vendors.
  • As discussed briefly in the introduction, you'll need to prioritize your needs somewhere between "critical" and "nice to have." These requirements are largely critical for most purposes and can be marked as such. The requirements you add will have to be prioritized more carefully.
  • You'll also want to perform some informal third-party information gathering about the vendors. Are reviews of the vendors trustworthy? Have peers had any interactions and success with the vendor? Does the vendor have the ability to scale to meet your needs?
  • Schedule demonstrations of programs that seem like strong initial candidates. Make sure there is a question and answer session afterwards, and perform a post-demo evaluation.
  • A formal request for proposal (RFP) may or may not be necessary, depending on the level of information you acquire prior. However, formally requesting pricing and clarification of maintenance and additional service costs is useful. Just don't let price be the only thing that guides you.
  • Consider some of the intangibles. Does the vendor genuinely seem interested in your business and its needs? Do they communicate well and promptly? Do they seem flexible and able to accommodate a few special case requirements?
  • Be sure to consider future needs as you anticipate potential laboratory expansion, particularly into other nutraceutical, health, food and beverage, agricultural or environmental testing realms.
  • Don't be afraid to choose a cannabis laboratory consultant to help you with the vendor selection process. But be sure to verify they offer true benefit.

Caveats

First, note that this cannabis testing LIMSpec is still an evolving entity. Standards change. Regulations change. Procedures change too with such changes. That means that as those foundational characteristics shift, this set of requirements will have to also evolve. As such, do your homework and don't take everything you see here as fixed law. If you're responsible for investigating and/or purchasing a laboratory informatics system, be sure you have at least some familiarity with the cannabis testing industry, and by extension the standards and federal, state, and local regulations that affect it.

Second, as the legal status of cannabis in the U.S. changes, and state- and federal-based requirements evolve, laboratory informatics software tailored to cannabis laboratories will also have to evolve. This document will also need to reflect such changes. As such, this LIMSpec for Cannabis is also evolving, and as industry experts and researchers are able to provide additional feedback on this document, it will surely grow with more relevant sources and requirements. In other words, don't consider this specification firmly complete. While efforts will be made to update it based on new regulations and standards, you may have to add more items based on your own industry knowledge and insights. We welcome input.

References

  1. Pearce, O. (21 June 2016). "Software Vendor Selection: How to Define Your Requirements". Montrium Blog. Montrium, Inc. https://blog.montrium.com/blog/software-vendor-selection-defining-your-requirements. Retrieved 12 January 2021. 
  2. Pearce, O. (23 June 2016). "Software Vendor Selection: Finding the Right Vendor". Montrium Blog. Montrium, Inc. https://blog.montrium.com/blog/software-vendor-selection-finding-the-right-vendor. Retrieved 12 January 2021. 
  3. Pearce, O. (28 June 2016). "Software Vendor Selection: The Pitfalls and Successes of Vendor Demos". Montrium Blog. Montrium, Inc. https://blog.montrium.com/blog/software-vendor-selection-conducting-demonstrations. Retrieved 12 January 2021. 
  4. Pearce, O. (05 July 2016). "Software Vendor Selection: Requesting Proposals & Quotes". Montrium Blog. Montrium, Inc. https://blog.montrium.com/blog/software-vendor-selection-requesting-proposals-quotes. Retrieved 12 January 2021. 
  5. Persaud, D. (04 February 2016). "Business Requirements Gathering for Enterprise Software Selection". SelectHub Blog. Abuyo, Inc. https://www.selecthub.com/technology-selection/business-requirements-gathering-enterprise-software-selection/. Retrieved 12 January 2021. 
  6. Lichtenberger, A. (23 July 2012). "Six Steps for a Successful Vendor Selection". ITIL.org. https://blog.itil.org/2012/07/six-steps-for-a-successful-vendor-selection/. Retrieved 12 January 2021. 
  7. Poon, L. (29 May 2015). "Insider’s Guide to LIMS Selection". Genologics Blog. GenoLogics Life Sciences Software Inc. https://www.genologics.com/blog/insiders-guide-to-lims-selection/. Retrieved 20 September 2019. 
  8. "How to Select an ELN for Biology R&D". Benchling, Inc. https://benchling.com/static/docs/resources/eln-for-biology-rnd.pdf. Retrieved 12 January 2021.