"This is the best use of my time to remain current with what is going on in the industry."
The goal is to produce a list and description of the essential metadata required to be able to reenact the events of the trial. This list will be used for industry-wide consensus building. This team began in Dec 2023 and phas had discussions with the EMA IWG eSource team in June 2024 and will meet with the IWG again in Nov 2025. The team has presented at the eCF Autumn 2024 and Autumn 2025 workshops and will continue working on deliverables.
Europe/Hybrid Autumn Workshop, October 27-29, 2026, Zurich, Switzerland, hosted by BSI Software
eCF Webinar November: FDA warning letters for audit trail analytics
FDA warning letters tell us what went wrong, but what could your audit trail analytics program have caught earlier? Join our upcoming webinar for a practical, in-depth look at an FDA warning letter and learn how to identify missed signals, uncover blind spots, and strengthen your audit trail review program.