30th GQMA Annual Conference with QFINITY | September 17-18, 2026
At the 30th GQMA Annual Conference, Frank Henrichmann (QFINITY) leads the workshop “AI in Computerized System Validation” – how AI, in particular large language models and generative AI-enabled tools, can be integrated across the entire CSV lifecycle, in line with GAMP 5 Second Edition and CSA. Friday, September 18, 2026, 11:05-11:50.
The 30th Annual Conference of the GQMA (German Quality Management Association) takes place on September 17-18, 2026 at the Dorint Hotel Potsdam and focuses on quality management in the chemical and pharmaceutical industries across all GxP areas – with parallel streams on IT, GMP, GxP, AI, GLP, GCP, and pharmacovigilance.
The workshop
In the AI/CSV workshop stream, Frank Henrichmann shows in practice how AI-enabled tools can already support the validation of computerized systems today – building on the ISPE article “How AI Will Transform Computerized System Validation.” Using a sample system and a generally available language model, participants work through, among others:
- Structured capture, assessment, and mapping of requirements
- Risk-based validation planning
- Automated generation of test cases
- Creation of traceability matrices
The discussion covers the limits and risks of using AI in validation, regulatory acceptance, the critical role of the “human in the loop,” and the shift in the validation team’s role – away from document handling toward “quality architects.”
The validation team’s role is shifting – away from pure document handling toward quality architects.
Speaker: Frank Henrichmann, Senior Executive Consultant at QFINITY and Chair of the global GAMP Steering Committee. Focus: IT; level: intermediate; presentation language: German. Registration from late April.
