LII:LIMSpec/Introduction and methodology

Introduction

Merriam-Webster defines a "specification" as "a detailed precise presentation of something or of a plan or proposal for something."^[1] In other words, an existing or theoretical product, concept, or idea is presented in detail for a particular audience. In a broad sense, detailing the specifics about a project, concept, or idea to others is just common sense. This applies just as well to the world of software development, where a software requirements specification is essential for preventing the second most commonly cited reason for project failure: poor requirements management.^[2]

Over the years, a wide variety companies, consultants, and researchers have compiled public and private specification documents for laboratory informatics systems. These compiled lists of requirements for how a given laboratory informatics solution should be developed, delivered, and maintained have changed as technology and user demand evolved. More often than not, those requirements have been represented as a mix of "wishlist" requirements from potential and active clients, as well as regulation-mandated requirements. While this mix has served informatics software developers well, sometimes a fresh approach is required.

What follows is an attempt to look less at the wishlists of laboratories and more directly at what requirements current regulatory schemes, industry standards, and organizational guidelines place on the ever-evolving array of laboratory informatics systems being developed today. What does the United States' 21 CFR Part 11 have to say about how your laboratory information management system (LIMS), laboratory information system (LIS), electronic laboratory notebook (ELN), and other systems operate? What does the European Union's Annex 11 dictate in those same regards? The following five chapters list those requirements, supported by one or more regulations, standards, and guidelines.

Methodology

At its core, this LIMSpec—which has seen several iterations over the years—is rooted in ASTM E1578-18 Standard Guide for Laboratory Informatics. With the latest version released in 2018, an updated Laboratory Informatics Functional Requirements checklist is included in the appendix, which "covers functionality common to the various laboratory informatics systems discussed throughout [the] guide as well as requirements recommended as part of [the] guide." It goes on to state that the checklist "is an example of typical requirements that can be used to guide the purchase, upgrade, or development of a laboratory informatics system," though it is certainly "not meant to be exhaustive."

This LIMSpec borrows from that requirements checklist and then adds more to it from a wide variety of sources. An attempt has been made to find the most relevant regulations, standards, and guidance that shape how a compliant laboratory informatics system is developed and maintained. However, this should definitely be considered a work in progress, with more to be added with additional public and private comment on missing sources.

That said, this first revision taps into the following sources: