What the inspector wrote
The site's procedure required 'periodic' review of audit trails for the LIMS and chromatography data system. No frequency, scope or acceptance criteria were defined. No record of any review could be produced for the preceding two years. On examination of the audit trail during the inspection, fourteen instances of result reprocessing with manual integration were identified across nine batches, none of which had been noted on the analytical report or assessed before release.
Why it was cited
An audit trail that exists but is not reviewed is treated in the room the same as one that does not exist, because it has played no part in any release decision. Annex 11 section 9 expects regular review and the EMA data integrity Q&A expects audit trail review as part of the record review before batch certification.
The inspector will read the audit trail themselves, and if it contains reprocessing, aborted runs or deletions that the site has never looked at, the finding writes itself and the batches involved are named.
What would have prevented it
- A procedure that says which events are reviewed (reprocessing, manual integration, aborted and repeated runs, deletions, configuration changes), by whom, how often, and what a reviewer does when they find one.
- For data that support a release decision, the audit trail review is part of the data review, before certification, by someone independent of the analyst.
- A review record that names the system, the period, the filter used and the entries examined. 'Reviewed, no issues' with a signature is not evidence of a review.