Computer System Validation (CSV) is the process for ensuring that a computer system meets its intended use and complies with regulatory requirements. GAMP 5 is a set of guidelines published by (ISPE) for CSV in the life sciences industry. GAMP 5 categorizes computer systems in a way that helps determine ...

Computer System Validation (CSV) is the process of establishing documented evidence, which provides a high degree of assurance that a specific process will consistently deliver a computer system as its predetermined specifications and quality attributes [25]. The necessity of performing validation of ...