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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.
Latest articles
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.
GAMP & Pharma 4.0 Workshop “Implementing an AI Solution in a Pharma 4.0 Context”
At the ISPE Annual Meeting & Expo 2025, Frank Henrichmann co-led the GAMP & Pharma 4.0 workshop ‘Implementing an AI Solution in a Pharma 4.0 Context’ with Martin Heitmann, Brandi Stockton, and Paige Kane – around 100 participants discussed maturity assessment and risk-based GAMP approaches for AI.
At this year’s ISPE Annual Meeting & Expo 2025, a successful GAMP & Pharma 4.0 workshop took place – co-led by Frank Henrichmann with Martin Heitmann, Brandi Stockton, and Paige Kane, PhD, CPIP, and several other experts.
Titled “Implementing an AI Solution in a Pharma 4.0 Context,” the workshop brought together around 100 highly engaged participants to discuss practical aspects of implementing Artificial Intelligence (AI) and Machine Learning (ML) in GxP-regulated environments – fully aligned with ISPE Pharma 4.0 and GAMP principles.
The workshop focused in particular on:
Maturity assessment methods to evaluate organizational readiness for AI projects
Risk-based approaches in line with GAMP, specifically tailored to AI applications
The interactive format fostered lively discussions, knowledge sharing, and high-level peer-to-peer learning. Participants contributed diverse perspectives, questions, and real-world examples, resulting in a dynamic and insightful exchange.
Frank Henrichmann emphasized the importance of such events:
QFINITY thanks all contributors and participants for their active involvement in this exceptional workshop and looks forward to more stimulating discussions and collaboration around AI, Pharma 4.0, and GAMP.
For more information about this successful workshop and this year’s Annual Meeting, please visit ISPE’s website.