The authorization record that doesn't exist is the one an investigator will ask for.
What gets asked — and what doesn't exist
"Who made the determination that this CAPA was effective — and what evidence did they review before authorizing the closure?"
Authorization Record That Does Not Exist- ✗Who evaluated the effectiveness evidence
- ✗What regulatory standard governed the determination
- ✗Who formally authorized the closure decision
- ✗When that authorization was made
The CAPA was closed correctly. The effectiveness check was marked complete. The authorization logic was never captured — and that is what the investigator is asking for.
What a defensible authorization record contains
An IRR is not a document template. It is a structured authorization artifact — built to answer the exact questions an investigator will ask, in the order they will ask them.
See the authorization gap documented in a real scenario
"Who decided this CAPA was effective, and under which regulatory standard was that determination made?"
See the authorization record →"Who authorized the batch release decision, and what evidence was evaluated before approval?"
See the authorization record →"Who authorized this deviation disposition, and what risk evaluation supported the determination?"
See the authorization record →Every inspection scenario has an authorization record that should exist.
Ten case files. Each one reconstructs the investigator's question, the missing authorization record, and the IRR that closes the gap.
See all 10 inspection case files →