Chromatography audit trails are reviewed on a periodic schedule, not as part of each batch record review.
Step-by-step process flow:
Today
The review happens, but not at the point where it can affect the release decision.
The agent
Reads the audit trail review records and the batch release dates, and flags batches released before the related audit trail was reviewed.
Release, certify or disposition a batch
Close a deviation, investigation or CAPA
File anything with an authority
Write to your systems outside the transitions you approve
Send a message without a named person's approval
Contact a regulatory authority or a customer
Promote itself to a higher autonomy level
Make you compliant. Compliance decisions and accountability stay with you.
REVIEW AND REGULATION
The reviewer sees
The batches, the systems, the review dates and the gap.
Regulation
21 CFR 11.10(e); FDA guidance Data Integrity and Compliance With Drug CGMP (December 2018); EudraLex Volume 4, Annex 11, section 9, which requires audit trails to be regularly reviewed.
What does the agent do for audit trail review that is not tied to each batch?
The agent reads the audit trail review records and the batch release dates, and flags batches released before the related audit trail was reviewed.
What does the reviewer see?
The batches, the systems, the review dates and the gap.
Does the agent make the decision?
No. The agent prepares the finding and a named person decides. The agent never releases, certifies or dispositions a batch, never closes a deviation, investigation or CAPA, and never files anything with an authority.
Which regulations apply?
21 CFR 11.10(e); FDA guidance Data Integrity and Compliance With Drug CGMP (December 2018); EudraLex Volume 4, Annex 11, section 9, which requires audit trails to be regularly reviewed.
Send an export for one batch or lot and see the workspace run on your own data.
