"This is the best use of my time to remain current with what is going on in the industry."
With the increased focus on data integrity from regulators, the routine use of audit trail review as a tool is required. This team will explore and provide guidance on what is the recommended scope for review, provide definitions, determine ‘what’ data (and in what part of the data lifecycle) should be reviewed with an audit trail vs other data integrity controls and finally recommend ‘how’ an audit trail review should be conducted (frequency, visualizations, exception reports etc). A white paper will be released to eCF members in 1Q 2020 with the anticipation of releasing it to the public by 1Q 2021.
Americas Autumn Workshop, October 13-15, 2026, Bloomington IL, USA, hosted by GenInvo
APAC/Hybrid Autumn Workshop, October 22-23, 2026, Shanghai, China, hosted by Clario
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.