Panel Discussion with QFINITY on the future of clinical computer systems
QFINITY took part in a key 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-driven technologies will play an increasingly significant role.
As part of a specialist event featuring leading experts from Quality Management, Clinical Operations, and Digitalization, current developments in technologies and regulations in the clinical domain were presented and discussed.
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, together with other experts, discussed how organizations can practically integrate QbD into their clinical processes.
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.
