FDA Inspection Decision Scenario
Who Authorized the Data Integrity Exception?
What FDA investigators are actually asking
FDA Investigator Question
"Who made the determination that this data integrity exception did not compromise the reliability of your records?"
Inspector's Line of Inquiry
When investigators ask this question, they typically follow with:
- Who evaluated the scope of the data integrity exception before the conclusion was authorized?
- What GxP records were reviewed to assess the impact on data reliability?
- What regulatory standard was applied to the reliability determination?
- What findings would have required regulatory notification?
- When was the exception 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 has identified an audit trail exception in your electronic records. An investigation was opened and closed. The investigator asks who authorized the conclusion.
Authorization Gap
The data integrity investigation documents what was found and the corrective action taken. It does not document who made the formal determination that the exception did not compromise data reliability — or that this determination was an authorization event. 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 data integrity determination
- Scope of records reviewed during the assessment
- Regulatory standard applied to the reliability determination
- Authorization timestamp for the exception acceptance
- Rationale for why the exception did not compromise GxP data reliability
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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