What is GxP computer validation?

GxP computer validation is the process of ensuring that computerized systems used in regulated industries, such as pharmaceuticals and biotechnology, comply with Good Practice (GxP) guidelines. This involves rigorous documentation, testing, and verification to confirm that the systems operate as intended and maintain data integrity, security, and traceability. GxP validation is critical for meeting regulatory requirements set by agencies like the FDA and EMA, helping to ensure product quality and patient safety.