Computerized System Validation is not a new topic, but its importance has increased over the years since the Able Laboratories fraud case in 20051, the consequence of which was a change of the inspection focus to the electronic records in the systems, with a special interest in the Chromatographic Data Systems.
This discussion provides a comprehensive but short summary of the Computerized System Validation for a Chromatographic System, intentionally avoiding some key related topics, including, but not limited to, Analytical Instruments Qualification (AIQ), Analytical Methods Validation, vendor selection, vendor assessment, and Site Validation Master Plan.