Annual product reviews are overdue beyond the twelve-month cycle.
Step-by-step process flow:
The agent
Drafts the review from batch, deviation, change control and stability data, and holds it for review.
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
Regulation
21 CFR 211.180(e); EudraLex Volume 4, Part I, Chapter 1 (product quality review).
What does the agent do for annual product quality reviews past their cycle?
The agent drafts the review from batch, deviation, change control and stability data, and holds it for review.
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 211.180(e); EudraLex Volume 4, Part I, Chapter 1 (product quality review).
Send an export for one batch or lot and see the workspace run on your own data.
