Audit-trail review added to batch release
Ergopharm has added routine audit-trail review to its batch release process, so that the electronic record is examined as part of every release rather than only when an auditor asks for it.
Computerised systems that generate GMP data record who did what and when. That record is only a control if somebody reads it. Reviewing audit trails at release means that a changed result, a re-integrated chromatogram or a deleted injection is seen by the person deciding whether the batch ships, at the moment the decision is made.
“An audit trail nobody reads is not a control. It is a log file.”
The review is proportionate and defined: which systems, which events, and what constitutes an exception requiring investigation. Chromatographic data systems, the environmental monitoring system and the serialisation records are all in scope.
The practice sits within the ALCOA+ expectations for data integrity and the requirements for computerised systems in EU GMP Annex 11, and it applies equally to paper records, where original entries are never obliterated.
Key facts
- When
- At batch release, not only at audit
- Systems in scope
- Chromatography, environmental monitoring, serialisation
- Defined
- Which events reviewed, what counts as an exception
- Framework
- ALCOA+; EU GMP Annex 11
This notice describes Ergopharm’s own packaging and processes and how they follow published standards; it does not assert a specific national marketing approval.