FDA Inspection Decision Scenario
Who Authorized This CAPA Closure?
What FDA investigators are actually asking
FDA Investigator Question
"Who made the determination that this CAPA was effective, and what evidence supported that conclusion?"
Inspector's Line of Inquiry
When investigators ask this question, they typically follow with:
- Who reviewed the effectiveness check results before the closure decision was made?
- What data was considered when determining the corrective action was sufficient?
- What regulatory standard was applied to the effectiveness determination?
- What would have prevented the CAPA from being closed?
- When was the closure authorization made, and who is named as the decision owner?
Can your team answer this question in under five minutes? The Authorization Assessment identifies where your decision trail breaks before an investigator does.
Find Your Gaps →The authorization gap this scenario reveals
The investigator pulls a closed CAPA from eighteen months ago. The effectiveness check is marked complete. The investigator asks who authorized the closure.
Authorization Gap
The CAPA record shows corrective action steps were completed. It does not show who evaluated the effectiveness evidence and made the formal closure authorization — or that anyone did. This is the authorization gap: the decision was made, but it was never documented as an authorization event — with a named decision owner, the evidence reviewed, the regulatory standard applied, and a timestamped record of when the authorization occurred.
Why does this gap exist across so many compliance programs? The Decision Authorization Model explains the structural difference between what documentation systems produce and what inspectors evaluate.
Understand the Model →What evidence the investigator expects
- Named decision owner for CAPA closure authorization
- Effectiveness evidence reviewed prior to closure
- Regulatory standard applied to the effectiveness determination
- Authorization timestamp for the closure decision
- Rationale linking effectiveness data to closure justification
Organizations operating with authorization infrastructure produce this record at the moment the decision is made.
See how authorization capability scales across organizations →Inspection Case File
See exactly what this authorization gap looks like — and what closes it.
The case file reconstructs this scenario in full: the investigator's question, the record that existed, the authorization evidence that was missing, and the Decision Defense Record that resolves it.
Inspection Case File
Close this authorization gap
before inspection.
The case file documents this exact scenario — the investigator's question, the missing authorization trail, and the Decision Defense Record that produces the evidence inspectors expect.
Get the Case File →$149 · Immediate access · No account required
Not sure where all your gaps are? Take the free Authorization Assessment →