LABORATORY SOFTWARE IMPLEMENTATION IN REGULATED INDUSTRIES
Laboratory software that is used in laboratories that are subject to GLP, GALP and cGxP
regulations must be validated and must also comply with the requirements of the
electronic records and signatures regulation 21 CFR Part 11. In particular, software that
is used for Laboratory Information Management (LIMS) and Chromatography Data
Systems (CDS) must comply. Typically, implementation of LIMS and CDS software
involves sophisticated configuration and/or customization. The vendor or an expert third
party is often used for the software implementation.
To meet validation requirements it must be demonstrated that the software performs
according to a user requirements document and a functional design specification
document. The design specification document is usually developed during the
implementation and must demonstrate linkage to the requirements document.
To minimize cost and time for the software validation, the implementation process
(whether done by the vendor, a third party, or the laboratory) must be closely
coordinated with the validation process. This presentation will provide a process for time
and cost effective coordination of implementation and validation of laboratory software in
regulated laboratories.
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