A material was received and used after the supplier's approval had expired.
Step-by-step process flow:
Today
Approval dates sit in a supplier list. Receipts sit in the ERP. The two are compared at audit time, if at all.
The agent
Reads receipts from the ERP and approval validity from the supplier qualification record, and flags receipts after the lapse date.
Next
A follow-up to supplier quality, tracked until requalification or disposition.
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 receipt, the lot, the batches that used it and the approval dates.
Regulation
21 CFR 211.84, testing and approval of components; EudraLex Volume 4, Part I, Chapter 5.
What does the agent do for material received after the supplier approval lapsed?
The agent reads receipts from the ERP and approval validity from the supplier qualification record, and flags receipts after the lapse date.
What does the reviewer see?
The receipt, the lot, the batches that used it and the approval dates.
What happens after the reviewer confirms?
A follow-up to supplier quality, tracked until requalification or disposition.
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 211.84, testing and approval of components; EudraLex Volume 4, Part I, Chapter 5.
Send an export for one batch or lot and see the workspace run on your own data.
