FDA Inspection Decision Scenario
Who Authorized This Computerized System Validation?
What FDA investigators are actually asking
FDA Investigator Question
"Who made the determination that this system was validated for its intended use, and what was the regulatory basis?"
Inspector's Line of Inquiry
When investigators ask this question, they typically follow with:
- Who reviewed the test execution results before the system was authorized for GxP use?
- What GAMP 5 risk category was applied and who made that determination?
- What critical requirements were verified before the validation was accepted?
- What test failures or deviations were evaluated before the conclusion was made?
- When was the system validation formally authorized, and who is the named 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 CSV package for a GxP system. Protocols and test scripts are present. The investigator asks who made the formal validation authorization decision.
Authorization Gap
The CSV package documents test execution and results. It does not document who evaluated the totality of validation evidence and made the formal authorization that the system was fit for its intended GxP use. 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 system validation authorization
- Regulatory framework applied to the validation determination
- Evidence reviewed before the validation was authorized
- Authorization timestamp for the validation acceptance
- Rationale linking test evidence to the fit-for-intended-use determination
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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