Audit Trail
An audit trail is an immutable, chronological record of all system activities, data changes, and user actions required for regulatory compliance.
What is Audit Trail?
An audit trail is a secure, chronological record that provides documentary evidence of the sequence of activities affecting any operation, procedure, or event. In the context of electronic monitoring systems, an audit trail records every data entry, modification, deletion, and system event — including who performed the action, when, and the reason for the change.
For FDA 21 CFR Part 11 and EU Annex 11 compliance, audit trails must be immutable (cannot be altered or deleted), automatically generated (not dependent on user action), and readily available for review during regulatory inspections.
Why It Matters
Audit trails are the backbone of data integrity in regulated industries. They prove that monitoring data has not been tampered with and that any anomalies were properly investigated and documented. Without a compliant audit trail, regulatory inspectors cannot trust the validity of your monitoring data — potentially invalidating years of compliance records.
Frequently Asked Questions
What should an audit trail record?
A compliant audit trail should record: creation, modification, and deletion of data; the original value and new value for any change; the user ID of who made the change; the date and time (with timezone); and the reason for the change. All entries must be timestamped and immutable.