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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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ISPE EU Annual Conference | April 20-22, 2026
Meet QFINITY on site at the ISPE EU Annual Conference 2026 in Copenhagen and learn how to bring digital compliance, AI, and GxP requirements together in a safe, future-proof, and practical way.
QFINITY’s Contribution to ISPE Europe 2026
The digital transformation of the pharmaceutical industry is progressing rapidly. Artificial intelligence, cloud technologies, and data-driven automation are now integral to GxP-critical processes. At the same time, regulatory requirements for data integrity, transparency, and patient safety remain uncompromising.
Oliver Herrmann, CEO of QFINITY, is a member of the event’s Program Team. He also serves as Track Lead for the Digital Compliance track, together with Josef Trapl and Niels de Blende. In this role, he is responsible for the track’s structure, technical depth, and overall content direction.
Content Focus: Digital Compliance
The Digital Compliance track addresses one central question:
How do you ensure lasting GxP compliance in AI-enabled, cloud-based, and continuously evolving system landscapes?
1. GxP Principles in the Age of AI
2. From Document-Based to Data-Driven Validation
3. Data Integrity, Trust, and Decision-Making
4. Next Generation Digital Compliance
For more information about the event and to register for the ISPE EU Annual Conference, please visit the ISPE website.
ACDM26 Conference with QFINITY | March 15-17, 2026
QFINITY will participate in the ACDM26 Conference in Berlin. The international conference is one of the leading events for professionals in Clinical Data Management and clinical research. It also draws experts in regulatory affairs and digital innovation across the life sciences industry.
As part of the conference program, Frank Henrichmann, Senior Executive Consultant at QFINITY, will deliver a presentation titled “Rewriting the Rulebook: How AI Will Transform Computer System Validation.”
The presentation will explore how Artificial Intelligence (AI) could fundamentally transform Computerized System Validation (CSV) in GxP-regulated environments. Traditional validation approaches are often time-consuming, highly manual, and resource-intensive.
The session will demonstrate how modern AI technologies may one day analyze and structure requirements, generate and execute test cases, and automatically document validation evidence. This has the potential to make the validation of clinical systems more efficient. It could also enable continuous compliance monitoring and improve audit readiness.
At the same time, the presentation highlights that the success of this transformation depends heavily on high-quality, well-structured requirements. It will also address key challenges such as the regulatory acceptance of AI-generated evidence, the validation of the AI tools themselves, and the role of human oversight in AI-supported validation processes.
Key Learning Objectives of the Presentation
Participants will gain insights into three central aspects of AI-supported validation:
1. Application of AI in system validation
Understanding how AI technologies can be applied to the validation of GCP and other clinical systems. In particular, it shows how they can improve efficiency, test coverage, and compliance.
2. Importance of high-quality requirements
Recognizing the critical role that precise, structured, and complete requirements play in enabling successful AI-supported validation.
3. Transition to AI-supported validation processes
Identifying key challenges and practical steps involved in moving from traditional CSV approaches to AI-supported validation workflows in regulated environments.
Exchange at ACDM26
The ACDM26 conference provides a platform for international exchange on current developments in Clinical Data Management. It also covers emerging technological and regulatory challenges in clinical research.
QFINITY looks forward to contributing to the discussion. The focus will be on how AI, regulatory requirements, and technological innovation will shape the future of Computer System Validation.
You can find further information about the ACDM26 Conference here.
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)↗