Audit Trails: What FDA Expects under Part 11

Q: What exactly does FDA mean by its requirement for audit trails under 21 CFR Part 11?

A: An audit trail is meant to be a computer-generated time-stamp that records:

– The date and time someone makes a change to any data in an electronic record, and
– The actions that create, modify or delete electronic data or records.

In addition to showing the date/time of the change and the person who made the change, audit trails must make any changes evident (easily identifiable and accessible) and show the data prior to the change.

Answered by Denise Dion, EduQuest VP of Regulatory and Quality Services (18 years as an FDA investigator and co-editor, FDA Investigations Operations Manual) and lead instructor of EduQuest’s training class called The CAPA Clinic: FDA Rules for Effective CAPA Systems, Failure Investigations, and Complaint Management.


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