Gamp: Categories

In the regulated life sciences industry (Pharmaceuticals, Biotech, Medical Devices), ensuring that computer systems do not compromise patient safety, product quality, or data integrity is paramount. The GAMP 5 Guide (Good Automated Manufacturing Practice), published by ISPE, provides a practical, risk-based framework for validating these systems.

Review your current system inventory. If a system labelled "Category 3" has configuration settings, user roles, or workflows, it may actually be Category 4—and your validation may be insufficient.