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Blogging

Audit Trail vs Audit Log: What Regulators Actually Expect

Byadmin September 18, 2025September 19, 2025

Introduction

“Audit trail” and “audit log” are used interchangeably, but they’re not the same in regulated contexts. System logs are useful for admins; audit trails must stand up in quality and regulatory inspections. Here’s how to tell them apart and make yours review‑ready.

What is an audit trail?

A secure, immutable, time‑stamped record of who did what and when to a GxP record. It must be linked to the specific record and show relevant details (including before/after values where meaningful).

What is a system/audit log?

A broader technical log: logins, server errors, background jobs, etc. Useful for IT/security, but not a substitute for record‑level audit trails required for regulated data.

What belongs in an audit trail

User ID (unique), date/time (timezone aware)
Action (create/edit/approve/e‑sign)
Object/record reference (which CAPA, which document revision)
Before/after values when a change affects the record’s meaning
Reason for change if your SOP requires it

Good examples

Document revision approval shows approver identity, meaning of signature, time, and links to both versions.
CAPA due date change: who changed it, when, old vs new date, and reason code.

Pitfalls that cause findings

Editable or deletable trails (no immutability)
Missing timezone sync (timestamps don’t reconcile)
Calling a server log an “audit trail”

Make yours inspection‑ready

Immutable storage and RBAC controls
Accurate time sync (NTP) and timezone consistency
Filters and exports so inspectors can follow a story quickly

How an eQMS helps

Trails on every object (documents, CAPAs, training)
E‑sign captures identity, meaning/intent, and time
AI Assist: summarizes a long change history into a reviewer‑friendly paragraph

FAQ

Do we need before/after for every field? Only when the change alters record meaning.

Can Excel be an audit trail? Not reliably—hard to make immutable with role controls.

Conclusion

Keep logs for IT; keep audit trails for quality. Design your system so inspectors can trace who‑what‑when on any GxP record in seconds.

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