Many investigations were closed one at a time. Read together, they point to a common cause that none of them investigated.
Step-by-step process flow:
Today
Each investigation is reviewed on its own. Patterns across them depend on someone remembering.
The agent
Reads closed investigations and compares equipment, materials, shifts and stated causes across them.
Next
The Head of Quality decides whether to open a new investigation or CAPA.
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 proposed consolidated investigation with the shared factors and the source investigations.
Regulation
ICH Q9(R1); ICH Q10; 21 CFR 211.192, which extends investigations to other batches that may be associated.
What does the agent do for investigations that share one uninvestigated cause?
The agent reads closed investigations and compares equipment, materials, shifts and stated causes across them.
What does the reviewer see?
A proposed consolidated investigation with the shared factors and the source investigations.
What happens after the reviewer confirms?
The Head of Quality decides whether to open a new investigation or CAPA.
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 Q9(R1); ICH Q10; 21 CFR 211.192, which extends investigations to other batches that may be associated.
Send an export for one batch or lot and see the workspace run on your own data.
