GxP Systems & Digital Compliance Training

The live online training “GxP Systems & Digital Compliance Fundamentals” takes place on 8 May 2026. QFINITY CEO Oliver Herrmann will deliver the training together with Martin Heitmann. The focus is on AI compliance, GMP requirements, Annex 11, and the Annex 22 Draft. The session will also present practical approaches for using AI safely in regulated GxP environments.

Artificial intelligence is making its way into more and more GMP-relevant processes and systems. This creates new opportunities – and new requirements for validation, data integrity, governance, and inspection readiness. The training addresses exactly this interface. It covers fundamentals and current developments in computerized systems and digital compliance, along with the regulatory-compliant use of AI in the GMP environment.

Participants will get a structured overview of the current Annex 11 requirements. The session will also discuss the possible impact of the revised Annex 11 drafts and the new regulatory perspectives arising from the Annex 22 Draft, and will include the ISPE GAMP perspective on good practices for the quality of computerized systems. A particular focus is the effective, safe, and compliance-oriented use of AI in GxP environments.

Oliver Herrmann, CEO and Founder of QFINITY, and Martin Heitmann will deliver the training. Oliver Herrmann is an internationally recognized expert in validation, technology quality, data integrity, and system implementation. Martin Heitmann brings extensive expertise in GAMP AI and GxP compliance. Among other roles, he is Co-Lead of the ISPE GAMP Guide: Artificial Intelligence.

You can find further information about the training here. For more QFINITY events, see Meet QFINITY.