A CAPA has an effectiveness criterion that measures the action, not the problem, so it will pass while the issue continues.
Step-by-step process flow:
Today
Effectiveness criteria are written once and rarely challenged.
The agent
Reads open CAPAs, their criteria and later related deviations, and flags criteria that do not measure recurrence.
Next
The CAPA owner decides whether to revise.
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 CAPA, the current criterion, related events since, and a proposed revised criterion.
Regulation
ICH Q10, corrective action and preventive action system.
What does the agent do for a CAPA effectiveness check that will pass while the issue recurs?
The agent reads open CAPAs, their criteria and later related deviations, and flags criteria that do not measure recurrence.
What does the reviewer see?
The CAPA, the current criterion, related events since, and a proposed revised criterion.
What happens after the reviewer confirms?
The CAPA owner decides whether to revise.
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?
ICH Q10, corrective action and preventive action system.
Send an export for one batch or lot and see the workspace run on your own data.
