QFINITY updates - publications and committee work
QFINITY · Updates

The latest from QFINITY and the field.

An overview of updates beyond events and projects: articles and publications, work in industry bodies and committees, awards, and our perspective on new regulations.

At a glance

Publications, committee work and more.

QFINITY auf dem 5. ACDM Symposium zu KI in klinischen Studien 2026 in London

QFINITY will be attending the 5th ACDM Symposium on Artificial Intelligence in Clinical Trials (June 23-24, 2026, London) – represented by COO Marcus Schwabedissen, who will co-moderate the panel discussion “Turning AI into Impact: Real-World Applications in Clinical Data Management.”

QFINITY will be attending the 5th Annual ACDM Symposium on Artificial Intelligence in Clinical Trials, taking place on June 23-24, 2026, in London. The symposium brings together experts from pharmaceutical companies, CROs, and technology providers to discuss the current and future role of AI in clinical trials. The focus is on practical insights, real-world case studies, expert discussions, and opportunities for exchange on topics such as agentic AI, AI strategies, practical implementation experience, and the next phase of AI in clinical trials.

QFINITY will be represented by Marcus Schwabedissen, COO and Consultant at QFINITY. With his extensive experience in GxP-regulated life sciences and IT environments, computerized system validation, IT quality management, risk management, and regulatory compliance, he brings a practice-oriented perspective on the responsible and compliant use of AI-supported systems in regulated environments.

Together with Jennifer Duff and Tim Armitage, Marcus Schwabedissen will co-moderate the panel discussion “Turning AI into Impact: Real-World Applications in Clinical Data Management.” The focus is on where AI already creates real value in clinical data management today, where implementation remains challenging, and which organizational, technical, and regulatory prerequisites are needed to translate the potential of AI into measurable impact.

For QFINITY, the symposium is an important opportunity to exchange with international experts and discuss practical approaches to AI governance, validation, data integrity, and lifecycle management – and how AI can be used in regulated environments in a controlled, risk-based, and auditable way.

Beitragsaufruf ISPE Annual Meeting 2026 GAMP-Track - QFINITY

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.

Titelbild zum Beitrag: Ehrenamts-Porträt über Frank Henrichmann in Pharmaceutical Engineering veröffentlicht

Pharmaceutical Engineering, ISPE’s professional magazine, features Frank Henrichmann – Chair of the GAMP Global Steering Committee and Senior Executive Consultant at QFINITY – in its January/February 2026 issue, recognizing his long-standing volunteer engagement for GAMP guidelines and Good Practice Guides.

Our Senior Executive Consultant Frank Henrichmann is featured in the latest issue (January/February 2026) of Pharmaceutical Engineering. The magazine of the International Society for Pharmaceutical Engineering (ISPE) regularly publishes “volunteer profiles,” and the current one features Frank Henrichmann.

Volunteer engagement not only strengthens the community – it drives quality and compliance in an increasingly digital industry.

The article highlights Frank’s long-standing commitment to the ISPE community. It also showcases his expertise in Quality Management, Computerized System Validation (CSV), and Compliance. Frank serves as Chair of the GAMP Global Steering Committee and has spent many years helping advance GAMP guidelines and Good Practice Guides. He has also contributed to key ISPE/GAMP publications.

QFINITY is also featured in the profile as Frank’s professional home. As a Senior Executive Consultant, he helps life sciences companies and technology providers address validation and quality challenges in GxP-regulated environments in an efficient, practical, hands-on way.

We congratulate Frank on this publication and thank him for his continued volunteer commitment, which not only strengthens the community but also helps advance quality and compliance in an increasingly digital industry.

Read the article: The volunteer profile “Frank Henrichmann – GAMP® Global Steering Committee Chair” is available on the ISPE website.

Read the profile at Pharmaceutical Engineering (ispe.org)↗