Not every feature needs rigorous testing. You must perform a risk assessment to determine which configurations are critical to patient safety, product quality, and data integrity.

The team treated Category 4 as a pure black-box, assuming all configurable parameters were benign. They lacked a parameter criticality assessment .

Gamp 4 Category __top__ Guide

Not every feature needs rigorous testing. You must perform a risk assessment to determine which configurations are critical to patient safety, product quality, and data integrity.

The team treated Category 4 as a pure black-box, assuming all configurable parameters were benign. They lacked a parameter criticality assessment . gamp 4 category