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.