What Does EU GMP Annex 22 Mean for ERP Systems?
By Thomas Brünger, Managing Partner
EU GMP Annex 22 sets the expectations for using artificial intelligence in GMP-relevant processes. For ERP systems it means that AI features and AI agents — not the deterministic parts of the ERP — need defined boundaries, human oversight, complete audit trails, and validation appropriate to their risk. It extends the existing computerised-systems expectations (Annex 11) to cover the specific characteristics of AI.
What changes for an ERP
Standard, deterministic ERP logic continues to fall under Annex 11. Annex 22 becomes relevant where an ERP applies AI or machine learning to GMP-relevant decisions — demand forecasting that drives production, anomaly detection in quality data, or agents that act on records. For those, the non-deterministic nature of AI raises specific questions about test coverage, explainability, human oversight, and control of the model over time.
The practical implication
Manufacturers should know where AI is used or planned in GMP-relevant processes, assess each use by risk, and ensure oversight and validation are in place before deployment. See AI in regulated manufacturing (Annex 22) for the detail, and can AI agents be used in a validated ERP system? for how this applies to agents specifically.
Independent architecture governance can help scope where Annex 22 applies in your environment.
Frequently asked questions
- Does Annex 22 apply to standard ERP features?
- It applies to AI/machine-learning functionality used in GMP-relevant processes. Deterministic ERP logic falls under Annex 11; where an ERP uses AI (forecasting, anomaly detection, agents) that touches GxP decisions, Annex 22 considerations apply.
- What should manufacturers do now?
- Inventory where AI is used or planned in GMP-relevant processes, assess the risk, and put oversight and validation in place before deployment — the same discipline as any computerised system, adapted for AI's non-determinism.