LII:LIMSpec/Putting LIMSpec to use

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Putting those requirements to practical use

The LIMSpec covered laboratory informatics requirements 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. That ultimately means a foundational reasoning is provided for each requirement, not necessarily a "just because I want it" reasoning. As foundational requirements, this LIMSpec should thus operate as an excellent starting point for building your own software requirements specification or for researching the best laboratory informatics solution for your laboratory.

Caveats

First, note that this 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 primary industry your laboratory serves, and by extension the regulations and standards that affect it.

Second, the number of industry-specific applications of laboratory informatics software continues to grow, and with them also the regulations and standards that affect those specialty laboratories. As such, this first time compiling these requirements surely missed some public-facing sources that affect how laboratories run, and by extension how their laboratory informatics applications should run. As mentioned with the first caveat, this version of LIMSpec is evolving, and as industry experts and researchers are able to provide additional feedback, it will surely grow with more relevant sources.

References