Computer System Validation (CSV) ensures that software and hardware systems in regulated environments, such as pharmaceuticals, operate reliably and securely. The process follows a structured lifecycle, including planning, user requirements specification, testing (Installation Qualification, Operational Qualification, and Performance Qualification), and validation reporting. CSV requires comprehensive documentation to demonstrate compliance with regulations like FDA 21 CFR Part 11 and EU Annex 11. A risk-based approach, as outlined in GAMP 5, prioritizes testing based on the system’s impact on product quality and patient safety. This validation is crucial for maintaining data integrity and traceability in systems like ERP, LIMS, or clinical data management platforms. Regular updates and change management ensure systems remain compliant throughout their lifecycle.

https://validfor.com/introduction-to-computerized-system-validation/

 
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