Gamp 5 Category 4 'link' Today

Since you are relying on the vendor’s code, you need to ensure they have a robust Quality Management System (QMS). For Category 4, a postal audit or a review of their development practices is often sufficient. 5. Testing (IQ/OQ/PQ)

The key distinction lies between and customization . Configuration involves setting standard, pre-tested parameters—such as defining user roles, setting approval workflows, or creating data entry forms—without altering the underlying source code. Customization (Category 5), conversely, involves writing new code, which introduces novel risks. Category 4 systems leverage the vendor’s tested core, but the act of configuring creates a unique instance that must be validated in its user environment. gamp 5 category 4