Marcus Schwabedissen, COO, and Frank Henrichmann, Senior Executive Consultant, from QFINITY will be at the ACDM Annual Meeting in Copenhagen. This Meeting will take place from 3rd– to 5th March.
We are very pleased that Frank Henrichmann will present on that conference on the topic of “How to comply with EU Guideline on computerised systems and electronic data in clinical trials”. This regulatory guideline was released by the EMA in 2023. It is the most extensive and detailed guidance ever published specifically for GCP systems. The EMA guideline covers key definitions and principles like Source Data, Responsibilities, and Data Integrity, expectations on Computerized systems, and their validation, including vendor management. Electronic data, from capturing data to Audit trail review and migration, are covered along with security expectations.
His presentation will focus on the key topics addressed in that guideline and challenges in the adoption of it.
What were the reasons and intentions of the regulators when creating this guidance?
What are the most critical changes, and how can we address them?
The key focus of the presentation will be the validation of computerised systems used within clinical trials at clinical sites. He will also talk about the expectations on vendor oversight and collaboration especially in the usage of Software-as-a-Service (SaaS) and the detailed expectations on data archiving and retention.
We are looking forward to meeting you there and to discuss technology quality management topics with you.
For more information about the ACDM Annual Meeting click here.