"Show me who authorized continued processing after this deviation was identified, what evidence they reviewed, and why that decision was justified."
Your deviation report documents what happened.
It does not document who authorized what came next.
The deviation file captures the event — the observation, the investigation, the corrective action. The batch record shows execution continued. QA signatures are present.
But the authorization logic is missing. The specific moment when a qualified individual reviewed the evidence, assessed the risk, applied a regulatory standard, and formally authorized continued processing — that decision is not recorded as a discrete event.
- Deviation report documents the event, not the authorization decision
- Batch record shows execution continued, not who authorized continuation
- QA signature exists, but authorization rationale is absent
- 21 CFR Part 211.192 is referenced nowhere in the decision trail
Under inspection, the investigator is not looking at the deviation. They are looking at the decision to continue. If that decision cannot be reconstructed, the documentation gap becomes the observation.
Could you reconstruct the authorization if the inspector asked today?
If a deviation occurred at your site last quarter and manufacturing continued, could you produce a record showing who authorized continuation, what evidence they reviewed at the time of the decision, which regulatory standard governed the authorization, how risk was evaluated, and why continued processing was justified — not reconstructed after the fact, but documented at the moment the decision was made?
If the answer involves locating emails, interviewing the QA director, or reviewing meeting notes — the authorization record does not exist. What exists is a reconstruction. Investigators distinguish between the two.
A Decision Defense Record captures the deviation authorization as a formal decision event: the decision being authorized, the regulatory basis that governed it, the evidence reviewed before the decision was made, the risk evaluation applied, the authorization rationale, and the residual risk accepted. Each element is required. None can be inferred.
The record is locked at the moment of authorization with a verification fingerprint. It cannot be amended retroactively. It answers the inspector's question precisely because it was created at the moment the inspector's question became relevant — not after.
Produce the authorization record for your deviation decision. Upload the evidence. The system drafts the record. You review, edit, and authorize. Authorization locks the record permanently.
Get the Deviation Continuation Case File
Scenario-specific. Shows exactly what your authorization record is missing and what a defensible record looks like for this decision.