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Shaping the regulated quality of tomorrow.
Articles and analysis from our own work across GxP, pharma, quality management, GAMP and AI - what is changing in the regulated environment, what it means in practice, and what is happening inside our company.
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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.
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:
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.”
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.
Program and registration at GQMA (gqma.de)↗
48th GAMP D-A-CH Forum with QFINITY | September 9, 2026
We are glad to be at the 48th GAMP D-A-CH Forum!
The forum of the ISPE D/A/CH GAMP Community of Practice takes place on September 9, 2026 at the NH Vienna Airport Conference Center in Schwechat near Vienna (SIG sessions the day before, September 8). It centers on computerized systems and their regulatory requirements in the life-sciences industry.