FDA Inspection Decision Scenario
Who Authorized the Periodic Review Conclusion?
What FDA investigators are actually asking
FDA Investigator Question
"Who made the determination that this system remained in a state of control, and what evidence supported that conclusion?"
Inspector's Line of Inquiry
When investigators ask this question, they typically follow with:
- Who reviewed the trend data before the state-of-control conclusion was authorized?
- What adverse trends were evaluated as part of the review?
- What regulatory standard governed the state-of-control determination?
- What findings would have prevented the system from being declared in control?
- When was the review conclusion formally authorized, and who is the named 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 is reviewing an annual product review. Trend data is present. The review is marked complete. The investigator asks who authorized the state-of-control conclusion.
Authorization Gap
The periodic review documents data trends and observations. It does not document who evaluated the totality of evidence and made the formal authorization that the system remained in a validated state of control. 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 individual accountable for the state-of-control authorization
- Evidence reviewed before the conclusion was authorized
- Regulatory standard applied to the control determination
- Authorization timestamp for the review conclusion
- Rationale linking trend data to the state-of-control determination
Organizations operating with authorization infrastructure produce this record at the moment the decision is made.
See how authorization capability scales across organizations →These gaps are not documentation failures. They are authorization failures. The Authorization Assessment maps exactly where your decision trail is missing these elements.
Start the Assessment →Authorization Assessment
Which of your decisions
have an authorization gap?
The Authorization Assessment identifies where your compliance decisions are undocumented as authorization events — the exact gap inspectors expose in scenarios like this one.
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Inspection Case Files document the authorization gap in detail — showing exactly what a Decision Defense Record resolves and what inspectors expect to see.
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