FDA Inspection Decision Scenario
Who Authorized the Process Validation Conclusion?
What FDA investigators are actually asking
FDA Investigator Question
"Who made the determination that this process was validated, and what evidence supported that conclusion?"
Inspector's Line of Inquiry
When investigators ask this question, they typically follow with:
- Who reviewed the process performance data before the validation conclusion was authorized?
- What statistical criteria were applied to the validation determination?
- What process variability was evaluated before the conclusion was made?
- What results would have required additional validation runs?
- When was the validation conclusion 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 process validation report. Statistical data is present. The validation is marked approved. The investigator asks who authorized the validation conclusion.
Authorization Gap
The validation report documents test results and statistical analysis. It does not document who evaluated the totality of evidence and made the formal authorization that the process was validated. 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 validation conclusion authorization
- Evidence reviewed before the conclusion was authorized
- Regulatory standard applied to the validation determination
- Authorization timestamp for the validation conclusion
- Rationale for why the data demonstrated process control within the validated state
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 →