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Comparison of V2025 to V2024 for both Form/S (eSource) and Form/F (eFile) and mapping to regulatory authority document statements
eCF eSRA Release 2025 is based on regulatory documents from FDA (USA), EMA (European Union), PMDA (Japan), CMPS (China), MHRA (UK) and ICH (International). The eClinical Forum will continue to monitor new releases and updates of regulatory documents from these agencies to determine if the eSRA forms questions should be updated.
This document provides an easy look at the differences between the 2 eSRA Forms (Form/S for eSource and Form/F for eFile systems) as well as a comparison to the previous versions of each as well as a mapping to the underlying regulatory statements that support each eSRA question.
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.