In the highly regulated world of pharmaceuticals, biotechnology, and medical devices, data integrity and patient safety are paramount. , which stands for Good Automated Manufacturing Practice , is the industry standard for achieving these goals.
While it sounds like a government regulation, GAMP is actually a set of guidelines published by the International Society for Pharmaceutical Engineering (ISPE). It provides a framework for manufacturers and suppliers to follow when designing, developing, and validating computerized systems used in regulated environments.