GAMP Track at ISPE EU Annual Meeting 2026

At the ISPE Europe Annual Conference 2026 in Copenhagen (April 20-22), Oliver Herrmann, Founder and CEO of QFINITY, served as Track Lead for the GAMP track „Digital Compliance by Design: GAMP, AI, data integrity and digital validation in a digitalized world“.

The life sciences industry is going through a profound digital transformation. Cloud platforms, AI-enabled tools and automation are changing how systems are built, validated and operated. These technologies open up opportunities; they also bring new risks and regulatory expectations.

At the heart of the track was the question of how „compliance by design“ works in practice: building conformity into processes, systems and technologies from the start, so that innovation can proceed without putting GxP compliance at risk. A particular focus was data integrity as the foundation for AI: without trustworthy, well-governed data, AI systems cannot perform reliably, least of all in regulated environments.

The track featured contributions on:

Compliance by design in practice: using AI, cloud and automation in line with GxP and regulatory requirements
Applying GAMP 5 Second Edition, the GAMP AI Guide and the Digital Validation Guide in digital initiatives
Annex 11 vs. Annex 15: where they differ and where they overlap for QA, IT and project teams
Data integrity in the digital age, particularly in the context of AI
Translating process requirements into risk-based, testable and GxP-compliant system requirements
Supplier qualification and continuous monitoring in outsourced or cloud environments
Business continuity and disaster recovery for regulated digital infrastructures

The sessions centered on case studies, lessons learned and forward-looking perspectives on emerging technologies and upcoming regulatory developments.