FDA Inspection Decision Scenario
Who Authorized the Cleaning Validation Acceptance?
What FDA investigators are actually asking
FDA Investigator Question
"Who made the determination that your cleaning validation data supported the claimed cleaning effectiveness?"
Inspector's Line of Inquiry
When investigators ask this question, they typically follow with:
- Who reviewed the swab and rinse data before the cleaning validation was accepted?
- What worst-case conditions were evaluated before the acceptance determination was made?
- What acceptance criteria were applied and who established them?
- What results would have required the cleaning process to be revalidated?
- When was the cleaning validation formally 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 cleaning validation records. Swab and rinse data are present. Acceptance criteria are met. The investigator asks who authorized the acceptance.
Authorization Gap
The cleaning validation record documents test results against acceptance criteria. It does not document who evaluated the totality of cleaning data 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 cleaning validation authorization
- Basis for acceptance criteria used in the determination
- Regulatory standard applied to the cleaning effectiveness evaluation
- Authorization timestamp for the validation acceptance
- Rationale for why the data demonstrated adequate cleaning across worst-case conditions
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.
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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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