Glossary

Compliance audit trail

A compliance audit trail is a time-stamped record of actions, changes, and approvals used to support review and traceability.

A compliance audit trail is a time-stamped record of actions, changes, approvals, and system events that can be reviewed to understand what happened, when it happened, and who or what performed the action. In manufacturing and industrial systems, it commonly supports traceability, data integrity, quality review, and audit preparation.

A compliance audit trail may record events such as a work instruction revision, an electronic signature, a quality disposition, a batch record entry, a parameter change, or a user access change. The record usually includes identifiers such as user, role, date and time, affected record, previous value, new value, and reason for change where applicable.

The term does not mean that a process is compliant by itself. It refers to the evidence trail that helps reviewers reconstruct activity and evaluate whether procedures, approvals, and controls were followed. It is also narrower than general logging, because an audit trail is intended to preserve meaningful, reviewable events tied to regulated, quality-sensitive, or controlled processes.

Compliance audit trails are commonly found in MES, QMS, ERP, PLM, electronic batch record, electronic device history record, and document control systems. They are closely related to version control, role-based access, electronic records, and traceability, but they are not a substitute for defined procedures, training, or system controls.

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