A deviation raised against a batch is open in the quality system. The executed batch record does not reference it.
compliance agent · batch record review
"Deviation DV-24-0391 is open against this batch. The executed record does not cite it on any page searched."
FINDING
Not cited
STATUS
Awaiting reviewer
Held for reviewer · finding + pages searched
Step-by-step process flow:
Today
The reviewer checks the record page by page. The quality system is a separate screen, searched only if something prompts it.
The agent
Reads open deviations in the quality system, links them to batch numbers from the ERP, and checks the executed record for a citation.
Next
On confirmation, a follow-up to the deviation owner, tracked until the record is corrected or the deviation closed.
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 deviation number, its status, the affected batch and the record pages searched, with reasoning.
Regulation
21 CFR 211.192, production record review; EudraLex Volume 4, Part I, Chapter 1.
What does the agent do for an open deviation the batch record does not cite?
The agent reads open deviations in the quality system, links them to batch numbers from the ERP, and checks the executed record for a citation.
What does the reviewer see?
The deviation number, its status, the affected batch and the record pages searched, with reasoning.
What happens after the reviewer confirms?
On confirmation, a follow-up to the deviation owner, tracked until the record is corrected or the deviation closed.
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 211.192, production record review; EudraLex Volume 4, Part I, Chapter 1.
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