A quality audit trail is the recorded history of quality-related actions, changes, approvals, and events in a process, record, or software system. It shows what happened, when it happened, who performed the action, and often what value or status changed.
In manufacturing, quality audit trails are commonly used in QMS, MES, eDHR, document control, inspection, nonconformance, CAPA, and training record workflows. A typical audit trail may include user IDs, timestamps, electronic approvals, previous and new field values, comments, status changes, and record creation or deletion events.
A quality audit trail is not the same as a quality audit. The audit is the review activity; the audit trail is the underlying record of system or process activity. It also differs from product traceability, which links materials, operations, equipment, and lots or serial numbers. Audit trails can support traceability and evidence review, but their primary purpose is to preserve the change and action history of quality records.