An inspection is announced. The team has to show what applied, which revisions were used, the evidence and the disposition of every exception.
Step-by-step process flow:
Today
Weeks of pulling records from each system into a shared folder.
The agent
Assembles the package per product and period from the linked records already in the workspace, and lists open exceptions.
Next
Follow-ups on open items until the inspection date.
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
A readiness verdict with every open item and its owner.
Regulation
21 CFR Part 211; EudraLex Volume 4, Part I; revised Schedule M of the Drugs Rules, 1945.
What does the agent do for an announced inspection?
The agent assembles the package per product and period from the linked records already in the workspace, and lists open exceptions.
What does the reviewer see?
A readiness verdict with every open item and its owner.
What happens after the reviewer confirms?
Follow-ups on open items until the inspection date.
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 Part 211; EudraLex Volume 4, Part I; revised Schedule M of the Drugs Rules, 1945.
Send an export for one batch or lot and see the workspace run on your own data.
