Gamp Software Categories Jun 2026

This is the foundational software used to manage the operating environment. It generally has no direct business functionality on its own but is essential for the operation of other systems.

Full Software Development Lifecycle (SDLC) validation with source code review. Deep-Dive Analysis of Individual Categories Category 1: Infrastructure Software & Lifecycle Tools GAMP categories for computerized systems - QbD Group gamp software categories

Software in this category has a low impact on product quality, patient safety, or data integrity. Examples of Category 2 software include word processors, spreadsheets, and other office productivity software. These software applications require some level of validation and verification, but the effort and rigor required are relatively low. This is the foundational software used to manage