QFINITY as training lead by the KKS Network

We were pleased to take on the training lead and moderation for an internal workshop organized by the KKS Network Fulda, focusing on the topic of “Auditing IT Vendors.”

Audits are a key component of quality assurance in clinical trials—especially when external service providers (vendors) are involved. To minimize risks for sponsors and investigational sites, while ensuring compliance with legal and regulatory requirements, IT vendor audits are becoming increasingly important.

Together with auditors and experts from IT, project management, and quality management, we delivered practical and hands-on training. Topics included regulatory fundamentals, compliance with GCP guidelines, as well as the preparation, execution, and structured follow-up of audits involving IT service providers.

Through interactive group work—such as using the example of an EDC (Electronic Data Capture) system provider—participants had the opportunity to actively explore and reflect on the interplay between theory and practice.

Our conclusion:
The interdisciplinary exchange demonstrated how crucial a shared understanding between IT, quality assurance, and operational units is for designing audit processes that are both effective and sustainable.

We would like to thank the KKS Network for their trust and the successful collaboration. We look forward to continuing to contribute to strengthening quality and compliance in clinical research.

For more information about the training and QFINITY’s role as training lead, please visit the KKS Network.