FDA Inspection Decision Scenario
Who Authorized This Batch Release?
What FDA investigators are actually asking
FDA Investigator Question
"Who authorized this batch release, and what evidence did they review before making that decision?"
Inspector's Line of Inquiry
When investigators ask this question, they typically follow with:
- Who evaluated the batch record before the release decision was made?
- Which deviations or exceptions were reviewed before authorization?
- What quality criteria were confirmed before the release signature was applied?
- What evidence would have changed the release decision?
- When was the authorization decision made, and is that timestamp documented?
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 batch records for a released lot. Every test result passes. The investigator sets them aside and asks a different question.
Authorization Gap
The batch record documents what was tested. It does not document who evaluated the totality of evidence and made the release decision — or what regulatory standard governed that judgment. 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 release authorization decision
- Evidence reviewed at the moment of authorization
- Regulatory standard applied to the disposition judgment
- Timestamp of the authorization event
- Rationale for why the evidence was sufficient to release
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 →