[verified]: Gamp Software Categories

This is the most common category in the pharmaceutical industry. It involves COTS software where the user can configure parameters to match their specific business processes. , but the application is tailored via configuration screens.

The GAMP guide was first published in 1994 by the International Society of Automation (ISA) and the Pharmaceutical Research and Manufacturers of America (PhRMA). The guide provides a framework for ensuring the quality and reliability of automated systems used in the pharmaceutical industry. One of the key principles of GAMP is that software should be categorized based on its risk and impact on product quality. gamp software categories