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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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Volunteer Profile on Frank Henrichmann published in pharmaceutical Engineering
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.
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)↗
Expert Article published in Pharmaceutical Engineering
Our expert article “How AI Will Transform Computerized System Validation” has been published in the latest issue of Pharmaceutical Engineering, the journal of the International Society for Pharmaceutical Engineering (ISPE). It also appears as a Feature Article on the ISPE…
Panel Discussion with QFINITY on the future of clinical computer systems
At Montrium’s Clinical QAI Day, Frank Henrichmann joined a key panel on the future of clinical computer systems – from rising quality and compliance demands to AI-enabled solutions that not only document processes but improve them.
QFINITY took part in a key panel discussion at Montrium’s Clinical QAI Day. The panel discussion focused on the future of clinical computer systems.
The demands for quality and compliance in clinical environments continue to rise. At the same time, the need for efficient, intelligent solutions is growing – systems that not only document processes but actively improve them. As a result, modern AI-enabled technologies will play an increasingly significant role.
The specialist event brought together leading experts from Quality Management, Clinical Operations, and Digitalization to present and discuss current developments in clinical technologies and regulations.
Frank Henrichmann of QFINITY contributed to core panel discussions in which experts shared their perspectives on the future of clinical computer systems.
QFINITY used the event to actively shape these developments, provide professional insights, and explore potential avenues for collaboration.
Building Quality In – Real-World QbD Implementation Stories
“Quality by Design” (QbD) is far more than a theoretical framework – it is a working and thinking approach that aligns clinical studies with quality from the very beginning.
In this panel, Frank Henrichmann and other experts discussed how organizations can integrate QbD into their clinical processes in practice.
The focus was on real implementation experiences:
How can cross-functional alignment between teams be achieved?
What process adjustments and workflow redesigns are required?
What challenges arise during implementation – and how can they be overcome?
What measurable improvements result for compliance, efficiency, and study quality?
The practical insights made one thing clear: QbD is not a one-time project but a continuous, collaborative approach that makes clinical studies smarter, more robust, and more resilient from a regulatory perspective.
AI Compliance Playbook – Navigating EMA and FDA Draft Guidances
Artificial intelligence is increasingly finding its way into clinical research – and with it, regulatory expectations continue to grow.
In another panel, Frank Henrichmann discussed the latest draft guidances and position papers from EMA and FDA on the use of AI in clinical studies.
The discussion explored, among other topics:
Requirements for risk-based credibility assessments of AI tools
Expectations regarding transparency, governance, and lifecycle management
Practical control mechanisms that organizations can already implement today
The session highlighted that responsible and compliant use of AI requires clear structures, continuous oversight, and a deep understanding of regulatory boundaries – while also demanding the courage to safely bring innovative solutions into practice.
A step into the future of quality management
QFINITY will continue to support and drive these developments – through active exchange, expertise, and participation in key industry dialogues.
You can find additional updates from QFINITY here. Feel free to visit QFINITY’s LinkedIn channel to stay informed.