"Who authorized final release of this batch, what disposition evidence did they review, and what was the regulatory basis for that release decision?"
Your batch record proves execution.
It does not prove the release decision was authorized.
The batch record is complete. QC results meet specifications. In-process controls passed. Certificate of Analysis is issued. The release signature is present.
But the release decision itself — who reviewed the totality of batch evidence, how they evaluated residual concerns, which regulatory standard governed the disposition, and why release was the justified conclusion — is not captured as a documented authorization event.
- Batch record documents execution, not the release authorization logic
- Release signature exists, but the evidence reviewed is not bound to the decision
- Disposition rationale is implicit, not formally stated
- Residual risk acceptance is undocumented
Under 21 CFR Part 211.192, release of a batch requires that any unexplained discrepancy be thoroughly investigated before disposition. The investigator's question is not whether the batch was made correctly — it is whether the release decision was formally authorized by someone accountable, based on documented evidence, at a specific moment in time.
If the investigator pulled your last batch release, what would they find?
For your most recently released batch, could you produce a record showing who authorized the release decision, what specific evidence they reviewed at the time of disposition, how they evaluated any open observations or deviations, which regulatory standard governed the release determination, and why release — rather than rejection or further investigation — was the formally justified conclusion?
If that record does not exist as a discrete document created at the time of release, the answer to the investigator's question requires reconstruction. Reconstruction is not authorization. It is the absence of authorization presented after the fact.
A Decision Defense Record for batch release captures the disposition decision as a formal authorization event: the batch being released, the regulatory basis governing disposition, the evidence reviewed before the release decision was made, the risk evaluation applied to any open items, the authorization rationale, and the residual risk formally accepted.
This record is issued at the moment of release, locked with a verification fingerprint, and permanently attributable to the individual who authorized the decision. It cannot be amended. It answers the investigator's question because it was created at the moment the question became relevant.
Upload your batch evidence. The system drafts the release authorization record. You review, edit, and authorize. The record locks at the moment of your authorization.
Get the Batch Release Authorization Case File
Scenario-specific. Shows exactly what your authorization record is missing and what a defensible record looks like for this decision.