In April 2026, the FDA issued its first warning letter focusing on inappropriate use of AI in cGMP processes. The issues raised concerned AI-generated specifications, process instructions, and Master Production Records that had not been reviewed by the Quality Unit. Our new blog post describes how we approach AI in engamp®, guided by our motto: “AI-supported – always compliant”:
- Every feature in engamp® is fully functional and useful even without AI; AI simply makes them faster and easier to use.
- Each AI function is designed so that the QMS remains in a state of compliance at all times.
- The AI makes suggestions, humans make the decisions, and no AI result takes effect without being reviewed.
You can learn more about the specific principles we apply, how we handle customer data, and how the regulatory framework surrounding the EU AI Act, Annex 22, and the ISPE GAMP® Guide is currently evolving on our blog.
