When planning a project of any type, it makes perfect sense to initially research and detail the specifics of the project to lay a solid foundation to work from. This is particularly true with software development, where careful initial planning is vital to ensuring the project is legitimate in the eyes of critical stakeholders and will meet specified goals. This demands the creation of a software requirements specification.
In the scope of developing and distributing a laboratory information management system (LIMS), the developer and distributor (i.e., the vendor) has a head-start on the targeted end user: the vendor has a standard to turn to in its requirements development. On the other hand, the laboratory seeking a LIMS doesn’t really have such a standard for developing a set of requirements for their acquisition, and many labs won’t even know they should develop a set of LIMS requirements before engaging in the acquisition process.
At its core, the LIMS Selection Workbook—which has seen several iterations over the years—is rooted in ASTM E1578-18 Standard Guide for Laboratory Informatics and 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. 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. This revision (2022) taps into more than 100 resources. Each requirement statement has at least one linked regulation, standard, or guidance item.
Many specification documents for laboratory informatic systems have been compiled over the years. This updated version incorporates standards and regulations and provides a guidance-based approach to building a spec document for your LIMS. A solid set of LIMS requirements can act as a checklist when determining which LIMS vendor is right for your Clinical Diagnostics & Research laboratory.