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 often referred to as software validation. Regulated companies perform validation projects to prove that their software or system is performing as it is supposed to and is not performing as it is not intended to. There are several examples of why software verification ...