When you view the categories through the lens of , you stop writing useless protocols and start protecting the patient. And that is the entire point of GAMP.

A Category 4 (Configured) system that manages warehouse inventory might require less rigor than a Category 3 (Non-configured) system that controls sterilization temperature . The category is a starting point, not the final verdict.

You don’t waste time over-validating low-risk, standard software (Category 1 or 3).

Note: Category 2 was removed in GAMP 5 as it was deemed redundant (formerly covering firmware). The Four Categories Explained Category 1: Infrastructure Software