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

On December 7, 2026 in Mannheim, Oliver Herrmann (QFINITY) – together with Jens Lambertz and Martin Heitmann – leads the official GAMP 5 pre-conference introductory training, the compact warm-up to the 19th GAMP 5 Conference, covering the fundamentals of risk-based CSV per GAMP 5 Second Edition and an outlook on AI.

The official GAMP 5 pre-conference introductory training takes place on Monday, December 7, 2026 in Mannheim – the kick-off to the 19th Official GAMP 5 Conference (December 8-9). A joint event of ISPE, APV, Concept Heidelberg and VDI/VDE-GMA.

QFINITY as trainer

Oliver Herrmann leads the training together with Jens Lambertz and Martin Heitmann and covers the fundamentals of risk-based validation of computerized systems per GAMP 5 Second Edition – with a focus on CSV basics and placing artificial intelligence in the regulated environment.

  • Risk-based CSV per GAMP 5 Second Edition
  • From the fundamentals to practical application
  • Placing AI in the regulated GxP environment

Built from the foundation up – risk-based validation made clear for newcomers.

Program and registration at the organizer (gamp-dach.de)

QFINITY beim 5. ACDM AI Symposium 2026 in London - KI in klinischen Studien und Datenmanagement

On June 23 and 24, 2026, QFINITY participated in the 5th Annual ACDM AI Symposium in London – a gathering of experts from pharmaceutical companies, CROs, and technology providers on the growing role of artificial intelligence in clinical trials and clinical data management.

QFINITY participated in the 5th Annual ACDM AI Symposium, which took place on June 23 and 24, 2026, in London. The symposium brought together experts from pharmaceutical companies, CROs, and technology providers to discuss the growing role of artificial intelligence in clinical trials and clinical data management.

Over the course of two days, experts shared practical use cases and implementation strategies and offered perspectives on the adoption of AI across the entire clinical development process. The focus was on data quality, governance, and regulatory requirements – as well as the responsible integration of AI into clinical research workflows.

For QFINITY, the symposium was an opportunity to exchange ideas with industry peers, strengthen existing partnerships, and explore how AI-supported solutions can support more efficient and compliant clinical data management.