FDA Inspection Decision Scenario
Who Authorized the Stability Data Acceptance?
What FDA investigators are actually asking
FDA Investigator Question
"Who made the determination that this stability data supported the claimed shelf life, and what was the basis?"
Inspector's Line of Inquiry
When investigators ask this question, they typically follow with:
- Who reviewed the stability data before the shelf-life determination was authorized?
- What ICH acceptance criteria were applied to the stability evaluation?
- What degradation trends were considered before the conclusion was made?
- What data would have required a shelf-life reduction?
- When was the stability 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 is reviewing stability records for a product approaching shelf-life limits. Data is present. The investigator asks who made the formal acceptance decision.
Authorization Gap
The stability file contains test results and trend analyses. It does not contain a record of who evaluated the data and made the formal authorization that the results supported the claimed shelf life. 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 stability data authorization
- Regulatory standard applied to the acceptance determination
- Evidence reviewed before the acceptance decision was made
- Authorization timestamp for the shelf-life determination
- Rationale for why the stability data met the acceptance criteria
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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