"Who authorized closure of this OOS investigation, what evidence supported the root cause conclusion, and how was the batch disposition decision formally justified?"
Your OOS file documents the investigation.
It does not document who authorized closure — or the disposition logic.
The OOS investigation file is complete. The laboratory investigation is documented. The full-scale investigation steps are logged. Assignable cause is identified. Corrective actions are noted. The batch disposition is recorded.
But the closure decision itself — who reviewed the totality of investigation evidence, how they validated the root cause conclusion, why the identified cause was sufficient to justify the batch disposition, and who formally authorized closure — is not captured as a discrete authorization event.
- Investigation file documents steps taken, not the closure authorization logic
- Root cause conclusion exists as a statement, not a documented determination
- Batch disposition is recorded, but the disposition authority is not formally stated
- No explicit record of who reviewed evidence before the closure decision was made
OOS investigation closure is among the highest-scrutiny events in FDA pharmaceutical inspections. Investigators challenge root cause conclusions, evidence adequacy, and disposition authority. The investigation file answers what was done. The authorization record must answer who decided it was sufficient — and why.
If an investigator pulled an OOS closed three months ago, what would they find?
For an OOS investigation closed at your site in the past six months, could you produce a record identifying who authorized closure, what specific evidence they reviewed to validate the root cause conclusion, how they assessed the adequacy of the investigation, what regulatory standard governed their evaluation, and why the batch disposition — whether release, rejection, or further testing — was formally justified based on the evidence reviewed at the time of closure?
If the authorization for closure exists only as a QA director's signature on the investigation form, without a documented rationale for why that individual concluded the investigation was adequate and the disposition justified, the investigator will construct their own narrative from the absence.
A Decision Defense Record for OOS investigation closure captures the closure authorization as a formal decision event: the investigation being closed, the regulatory basis governing closure criteria, the root cause and investigation evidence reviewed before authorization, the risk evaluation applied to the disposition decision, the authorization rationale for closure and disposition, and the residual risk formally accepted by the accountable individual.
The record is issued at the moment the closure decision is made, locked with a verification fingerprint, and permanently attributable to the individual who authorized closure. It does not replace the investigation file. It creates the authorization record that the investigation file cannot contain — the formal evidence that the closure decision was made, by whom, based on what, and why it was justified.
Upload your OOS investigation evidence. The system drafts the closure authorization record. You review, edit, and authorize. Closure is formally recorded at authorization.
Get the OOS Investigation Closure Case File
Scenario-specific. Shows exactly what your authorization record is missing and what a defensible record looks like for this decision.