Computerised System Validation

Computerised System Validation establishes documented evidence that a GxP computerised system does what it is intended to do and will continue to do so throughout its lifecycle (GAMP 5, FDA 21 CFR Part 11, EU GMP Annex 11). It spans requirements, risk assessment, verification, and ongoing control of the electronic records and signatures the system holds.

Nearly every GxP process now runs on software — LIMS, MES, ERP, chromatography data systems, building management. An unvalidated or poorly controlled system puts both product quality and data integrity at risk, and Part 11 / Annex 11 make those systems directly inspectable. CSV is how confidence in the software layer is established and maintained.

A risk- and category-based lifecycle that scales effort to system complexity and novelty, from configurable products to bespoke development.

Computer Software Assurance thinking — focusing testing on the functions whose failure would affect patient safety, product quality, or data integrity, and using critical thinking over rote documentation.

Part 11 / Annex 11 controls — audit trails, access control, and trustworthy electronic signatures — that make electronic records as reliable as paper.

Keeping systems in a validated state over time through change control, configuration management, and periodic review across the operational life of the system.

• ›System inventory and the validation status of each GxP system
• ›Audit trails, access control, and segregation of duties
• ›Change and configuration management keeping the system in a validated state
• ›Data backup, restore, and business-continuity for GxP data

Derived from the 6 standards SPEQ decodes for this discipline.