GAMP 5 divides software into categories based on three factors:
In regulated industries such as pharmaceuticals, biotechnology, and medical devices, computerized systems must be validated to ensure patient safety, product quality, and data integrity. The International Society for Pharmaceutical Engineering’s (ISPE) Good Automated Manufacturing Practice (GAMP) 5 guide provides a risk-based framework for validating these systems. Central to this framework is the categorization of software into four distinct categories based on complexity, customization, and intended use. This paper explores each GAMP software category—from infrastructure software to custom applications—detailing their definitions, validation strategies, and regulatory implications. Understanding these categories enables organizations to apply appropriate validation efforts, reduce costs, and maintain compliance with regulations such as 21 CFR Part 11 and EU Annex 11. gamp software categories