ISPE Annual Meeting & Expo with QFINITY | October 18-21, 2026

We are glad to be at the 2026 ISPE Annual Meeting & Expo!

It takes place October 18-21, 2026 at the Gaylord National Resort & Convention Center in National Harbor (Washington, D.C. metro area) – one of the central international conferences for the pharma and life-sciences industry. A virtual attendance option is also available.

QFINITY on stage

Two sessions in the “Digital – Data – Decision Integrity” track show how quality assurance and computerized system validation evolve as AI enters regulated GxP environments – moving away from mere documentation management toward deliberately designed system architecture.

Progressive QA in AI-Enabled GxP Environments

Oliver Herrmann (QFINITY) and Martin Heitmann (MH Consulting & Advisory GmbH)

AI is not simply introducing new tools – it changes how GxP computerized systems operate: execution shifts toward supervision, and deterministic behavior turns probabilistic. This does not reduce the need for quality assurance – it elevates it. Quality no longer emerges from validating isolated systems, but from the interaction of business processes, data, software, interfaces, and decision structures. QA evolves from a pure control function into an architect of controlled, reliable digital system landscapes. Responsible AI is not an add-on: it must be embedded into system architecture – including intended use, human oversight, and risk-based controls across the full lifecycle.

AI-Enabled Computerized System Validation

Frank Henrichmann (QFINITY)

How can AI technologies – particularly large language models, machine-learning-driven analytics, and generative AI – be integrated into the end-to-end lifecycle of computerized system validation (CSV), aligned with GAMP 5 Second Edition and CSA principles? Building on the ISPE Magazine article “How AI Will Transform Computerized System Validation,” the talk moves beyond vision and theory to what is already possible today: requirement gathering and mapping, automated test-case generation, test execution and evidence capture, auto-generation of traceability matrices, and risk-based validation planning. Validation-team roles shift along the way – from documentation management to “quality architect” responsibilities that design validation approaches and review AI-generated output to ensure compliance and quality.

Session and registration in the ISPE program (ispe.org)↗

Attending in person? Reach out – we look forward to connecting.