Audit trail
An automatic, immutable log of who did what and when in a system.
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An audit trail is a system's chronological logbook: who did what, when, and what were the old and new values. The defining difference from an ordinary log file is that an audit trail is kept automatically and cannot be edited or switched off afterwards.
In label management, the audit trail records the entire life of a label: who created the template, who made which change, who approved the new version, and which data was printed when on which printer. During an inspection, complaint, or recall, that is the question that must be answered: which label was on that product at that moment, and who approved it?
For regulated sectors an audit trail is mandatory (21 CFR Part 11, EU GMP Annex 11), but it is valuable beyond them too: discussions about "who changed this label" are settled with one search. With loose label files on a local PC there is no audit trail; central label management records it automatically.
Frequently asked questions — Audit trail
What is the difference between an audit trail and a regular log file?
An audit trail is kept automatically and cannot be altered or switched off after the fact.
Who is required to keep an audit trail?
Regulated sectors (21 CFR Part 11, EU GMP Annex 11), but it is valuable beyond those too.
Can I keep an audit trail with loose label files?
No. With loose files on a local PC there is no audit trail; central label management records it automatically.
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