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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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Frank Henrichmann Appointed Chair of the ISPE GAMP Global Steering Committee
QFINITY is pleased to announce that Frank Henrichmann, Senior Executive Consultant at QFINITY, has been appointed Chair of the ISPE GAMP Global Steering Committee. In this role, he succeeds Charlie Wakeham, whose exceptional commitment and inspiring leadership have significantly shaped the work of the GAMP network in recent years.
We sincerely thank Charlie for her vision and tireless dedication and are delighted that she will continue to serve on the Leadership Team as Past Chair.
Together with Co-Chair Thana Subramanian and Secretary Brandi Stockton, Frank Henrichmann will drive GAMP’s strategic direction and continued development. The mission of the GAMP Global Steering Committee is to foster innovation, digital transformation, and quality within the life sciences industry.
QFINITY is proud of Frank’s active engagement within the global ISPE community and congratulates him warmly on his appointment as Chair.
For more information about ISPE, please visit ISPE’s website.
QFINITY as training lead by the KKS Network
We were pleased to take on the training lead and moderation of an internal workshop organized by the KKS Network Fulda on “Auditing IT Vendors.”
Audits are a key component of quality assurance in clinical trials – especially when external service providers (vendors) are involved. IT vendor audits are becoming increasingly important for minimizing risks to sponsors and investigational sites while ensuring compliance with legal and regulatory requirements.
Together with auditors and experts from IT, project management, and quality management, we delivered practical, hands-on training. Topics included regulatory fundamentals, compliance with GCP guidelines, and the preparation, execution, and structured follow-up of audits involving IT service providers.
Through interactive group work – for example, on an EDC (Electronic Data Capture) system provider – participants were able to actively explore and reflect on the interplay between theory and practice.
Our conclusion:
The interdisciplinary exchange showed how crucial a shared understanding between IT, quality assurance, and operational units is for designing audit processes that are both effective and sustainable.
We thank the KKS Network for their trust and the successful collaboration. We look forward to continuing to help strengthen quality and compliance in clinical research.
For more information about the training and QFINITY’s role as training lead, please visit the KKS Network on LinkedIn.
Pharma 4.0 Conference with QFINITY | December 9-10, 2025
Oliver Herrmann leads the Smart Validation Track at the Pharma 4.0 Conference 2025.
Our managing director Oliver Herrmann will be leading the track “Smart Validation (CSV) & QA for Smart Technologies: AI and Beyond” at this year’s ISPE Pharma 4.0 Conference.
The event will take place on December 9-10 in Barcelona.
Cloud platforms, AI, and automation have long been a reality. They are changing how systems are developed, validated, and operated – and presenting companies with new regulatory questions. This is exactly where the track comes in: compliance should no longer be seen as a brake but as a driver of digital transformation.
The Pharma 4.0 Conference will focus on:
A highlight: authors and core team members of the official ISPE and GAMP guides will be there in person to share where the field is heading.
The bottom line: digital compliance is more than just a set of rules. It is what makes innovation and sustainable transformation possible in the first place.
👉 Register now for the Pharma 4.0 Conference and secure your spot.