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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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Events, case studies and insights.

19th Official GAMP 5 Conference with QFINITY | December 8-9, 2026

19th Official GAMP 5 Conference - December 8–9, 2026, Mannheim

At the 19th Official GAMP 5 Conference in Mannheim (December 8-9, 2026), Oliver Herrmann contributes in three ways: as co-moderator of a panel on the future of CSV, in the ISPE/GAMP/VDI update, and with his own talk on progressive, verifiable validation.

The conference takes place on December 8-9, 2026 at the Dorint Kongresshotel Mannheim (adjacent to the Congress Center Rosengarten); the official GAMP 5 pre-conference introductory training runs on December 7. A joint event of ISPE, APV, Concept Heidelberg and VDI/VDE-GMA.

QFINITY on the program

  • Panel discussion (Tue, December 8): “CSV at a turning point: Is our validation ready for digital reality?” – co-moderated with Alexander Kunz (Merck). Where does CSV really stand beyond SOPs, templates and project sign-off? Is classic CSV still enough, what does digital reality demand, what holds progress back – and what role does data governance play for the future of CSV?
  • “News from the ISPE / GAMP & VDI world” (Wed, December 9, 8:30): co-moderated with Stefan Münch – updates from VDI/VDE, GAMP D-A-CH, GAMP Europe and GAMP Global.
  • Talk (Wed, December 9): “Progressive CSV: How innovation becomes verifiable” – validation as a foundation rather than a sign-off, risk-based thinking as the steering logic.

Validation as a foundation rather than a sign-off – risk-based thinking as the steering logic.

3rd GAMP Conference: Artificial Intelligence Meets the Pharmaceutical Industry with QFINITY | December 10, 2026

3rd GAMP Conference: Artificial Intelligence Meets the Pharmaceutical Industry - QFINITY

At the 3rd GAMP Conference “Artificial Intelligence Meets Pharma” in Mannheim (December 10, 2026), Oliver Herrmann speaks on progressive QA in complex regulated environments – the architecture of computerized systems, the role of humans and the responsible use of AI.

The conference takes place on December 10, 2026 in Mannheim – a joint event of ISPE, APV, Concept Heidelberg and VDI/VDE-GMA. The focus: using AI in the regulated GxP environment – regulatory expectations (EU GMP Annex 22), practical implementation, the role of QA, supplier relationships and security aspects. It directly follows the GAMP 5 Conference (December 8-9) and the pre-conference introductory training (December 7).

The talk

“Progressive QA in complex regulated environments: the architecture of computerized systems, the role of humans and the responsible use of AI” – the key themes:

  • On silos and progressive QA: the context of regulated environments
  • Quality as the result of linked processes, data, software and interfaces
  • Responsible AI in process and system architecture
  • The central role of humans: judgment, oversight and accountability
  • The QA shift: from single-system testing to actively shaping digital system landscapes

Quality emerges from the interplay of processes, data, software and interfaces – not from testing a single system.

6th GAMP Conference GxP in the Cloud with QFINITY | December 10, 2026

6th GAMP Conference: GxP in the Cloud - QFINITY

QFINITY chairs the 6th GAMP Conference “GxP in the Cloud” in Mannheim (December 10, 2026): regulator, pharma QA and cloud providers at one table – with the guiding question of how control stays demonstrable when cloud, SaaS and AI change continuously.

Oliver Herrmann (QFINITY) and Frank Henrichmann jointly lead the conference. Date: December 10, 2026 in Mannheim – part of the GAMP conference week by ISPE, APV, Concept Heidelberg and VDI/VDE-GMA. The leitmotif: Cloud. AI. Continuous Assurance.

Who has to provide the evidence when the cloud changes overnight?

Cloud, SaaS, PaaS and AI change continuously – the provider delivers the platform and technical controls, while responsibility for intended use, validation, oversight and verifiable evidence stays with the regulated company.

Who is at the table

What matters most are the three perspectives that decide whether GxP cloud use holds up – and all of them are represented:

  • Regulator / authority: Dr. Arno Terhechte (Bezirksregierung Münster)
  • Pharma & QA: Hans Jochem Harnisch (Bayer AG), Susanna Nagel (Roche)
  • Cloud & supplier: Bill Reid (Google Cloud), Robert Geiger-Lebailly (SAP SE), David Garonzik (Validated Cloud), Sebastian Koch (p36)
  • Industry & consulting: Marcel Geers (Porsche Consulting), Gennadij Zarnikov and Cecilia Lo (Tenthpin Solutions)

Key topics

  • Shared responsibility – where does the provider’s platform responsibility end and your own GxP evidence duty begin?
  • Annex 11 draft – supplier oversight, SLAs, control logic and evidence for modern cloud services.
  • AI use cases and governance – use-case classification, GxP relevance, human oversight and decision paths.
  • Validation and a controlled operating phase – from a validated go-live to continuously demonstrable control.
  • Scalable supplier oversight – covering hyperscalers via group audits instead of a repeated audit marathon.
  • Cloud qualification evidence – classifying, adopting and bringing provider evidence into your own QMS.