FDA Inspection Decision Scenario
Who Approved This Change Control?
What FDA investigators are actually asking
FDA Investigator Question
"Who made the regulatory impact determination for this change, and what was the basis for that assessment?"
Inspector's Line of Inquiry
When investigators ask this question, they typically follow with:
- Who evaluated the regulatory impact of this change before implementation?
- What regulatory standards were reviewed during the impact assessment?
- What evidence was used to classify this change at its assigned impact level?
- What would have elevated the regulatory impact classification?
- When was the impact determination formally authorized, and who is accountable?
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 change control record for a validated system modification. Approvals are in the system. The investigator asks who made the regulatory impact determination.
Authorization Gap
The change control documents approvals and implementation steps. It does not document who evaluated regulatory impact as an authorization decision — or what evidence they used. 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 regulatory impact determination
- Regulatory standards evaluated during impact assessment
- Evidence reviewed to support the impact classification
- Authorization timestamp for the impact determination
- Rationale for why the change was classified at its assigned level
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 →