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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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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.
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.