A "LIMSpec” is a progressive, comprehensive documentation of a Laboratory Informatics Information System (LIMS or LIS) that was originally introduced by the Laboratory Informatics Institute (LIMStitute), a standards and organizational body, in 2007. This laboratory informatics industry tool starts as a requirements template which labs and/or consultants use to compile their system needs, usually when building and RFP, RFI or RFQ. It is distributed free as a service to the industry, and is updated as the LIMS acquisition process progresses through the system lifecycle. The stages of the LIMS lifecycle have been identified by the LIMStitute as:
- LS1 – Template, or “As Suggested”
- LS2 – Customized by lab/enterprise as RFP etc., or “As Requested”
- LS3 – Responded to by vendor, or “As Proposed”
- LS4 – Deployed and operational during a closely monitored “Go Live” period, or “As Delivered”
- LS5 – Fully deployed and operational LIMS/LIS, or “As it Lives”
- LS6 – Withdrawn from service, existing as a full historical record, or “As Retired”
The crucial element of the LIMSpec is its collection of system requirements, which are categorized by both type of laboratory and general function. These are gleaned from hundreds of real world RFPs, and include important criteria necessary to meet various regulatory compliance metrics and standards, including ASTM, ASCLD, APHL, 21 CFR part 11, 40 CFR part 3 (CROMERR), NELAC/NELAP (now TNI:), ISO 17025, HIPAA, GALP/GAMP and others.
Furthermore, the specifications each have a unique ID number which all parties can reference when discussing requirements. This provides a common language, comprised of commonly understood terminology. The result is enhanced communication, reducing still further time and resource inefficiency for the industry, in contrast to what has always been a rather murky and undefined procedural area.
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