What is GMP Computer System Validation?

GMP Computer System Validation (CSV) is the process of ensuring that computer systems used in the pharmaceutical and life sciences industries meet Good Manufacturing Practice (GMP) requirements. This validation ensures that software and hardware systems function as intended, maintain data integrity, and comply with regulatory standards such as FDA 21 CFR Part 11. Proper validation helps prevent errors, ensures product quality, and safeguards patient safety. The process typically involves planning, testing, documenting, and maintaining the validated state of computer systems.