Can this decision be defended under direct FDA investigator questioning?
The investigator's question is always the same:
"Who authorized this decision, based on what evidence, and where is that authorization recorded?"
Most quality systems document that a decision was made. None of them capture the authorization logic behind it. That gap is what produces 483 observations — not poor decisions, but undocumented ones.
This assessment identifies:
→ Your authorization risk level for this decision type
→ The specific gaps in your current documentation
→ What a complete authorization record looks like
5 questions. Results immediately.
No account required. Takes under 90 seconds.
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Enter your details to see your full risk breakdown — which gaps were identified, what an investigator would find, and the authorization record that closes each one.
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If this is not corrected before inspection:
You will not be able to produce an authorization record when asked
The decision will be challenged as undocumented and unverifiable
The gap will surface as a direct inspection finding
This is not a documentation issue. This is a failure to demonstrate decision control under inspection.
The case file does not explain compliance. It reconstructs the decision you cannot currently produce.