How to combine 21 CFR Part 11, EU-GMP Annex 11 requirements and how to apply these to local and global GCP systems

Different and ambivalent regulations for the same issue lead to uncertainty in the industry and potentially increase costs and risks while conducting international studies. This presentation will provide an analysis of the current understanding of Annex 11 and Part 11 in the context of GCP system implementations. Furthermore guidance will provided to ensure regulatory compliance of clinical systems regarding these regulations. This is imperative to ensure successful and compliant clinical trial conduct in a global environment. Combining requirements from different regulations enable an efficient validation of the relevant computerized systems and its infrastructures.