FDA Inspection Decision Scenario
Who Authorized the Validation Protocol Deviation?
What FDA investigators are actually asking
FDA Investigator Question
"Who made the decision to accept this protocol deviation, and what was the scientific and regulatory basis?"
Inspector's Line of Inquiry
When investigators ask this question, they typically follow with:
- Who reviewed the protocol deviation before the acceptance decision was made?
- What scientific evidence supported the determination that validation integrity was maintained?
- What regulatory standard was applied to the deviation acceptability assessment?
- What would have required the protocol to be reexecuted?
- When was the deviation acceptance authorized, 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 is reviewing a completed validation. A protocol deviation is noted and closed. The investigator asks who authorized the deviation acceptance.
Authorization Gap
The validation record notes the deviation was reviewed and accepted. It does not document who made the formal authorization decision — or what evidence justified accepting the deviation. 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 deviation authorization
- Scientific and regulatory basis for accepting the deviation
- Evidence reviewed before the acceptance decision was made
- Authorization timestamp for the deviation acceptance
- Rationale for why the deviation did not compromise validation integrity
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.
Start the Authorization Assessment →Free · No account required · Results in under 5 minutes
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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