Описание

Computerized System Validation (CSV) is a critical process used in regulated industries to ensure that computer-based systems perform as intended and comply with standards like FDA 21 CFR Part 11. It involves testing and documenting that systems consistently meet predefined specifications, ensuring data integrity and patient safety. The process spans the entire system lifecycle, from planning and requirements definition to testing, reporting, and eventual decommissioning. CSV is guided by frameworks like GAMP 5, which emphasizes a risk-based approach to focus validation efforts on high-impact areas. By maintaining thorough documentation, CSV helps organizations pass regulatory audits and avoid costly penalties. It’s essential for systems involved in manufacturing, clinical trials, and data management in life sciences.