"Who determined this CAPA was effective, what effectiveness evidence did they review before closure, and who formally authorized the closure decision?"
Your CAPA record documents the actions taken.
It does not document who authorized closure — or why.
The CAPA file is complete. Root cause is documented. Corrective actions are logged. Effectiveness check is marked complete. The closure signature is present.
But the closure decision itself — who evaluated effectiveness, what evidence they reviewed to confirm the CAPA met its criteria, and why closure was the formally justified conclusion — is not captured as a discrete authorization event.
- CAPA record documents actions, not the effectiveness determination
- Effectiveness check is marked complete, but the evaluator's reasoning is absent
- Closure signature exists without documented evidence review
- No formal statement of who accepted residual risk post-closure
CAPA effectiveness is one of the most frequently challenged areas in FDA 483 observations. Investigators do not question whether actions were taken. They question whether someone formally determined those actions were effective — based on evidence, under a stated standard, at a documented moment — and whether that determination is attributable to an accountable individual.
If an investigator pulled a closed CAPA from last year, what would they find?
For a CAPA closed at your site in the last twelve months, could you produce a record showing who made the effectiveness determination, what specific effectiveness evidence they reviewed before closure, how they assessed whether the corrective action addressed the root cause, which standard governed the closure criteria, and why closure — rather than continued monitoring or escalation — was the formally justified conclusion?
If that determination exists only as a checkmark, a workflow status, or a general statement that actions were complete, it is not an effectiveness determination. It is a process milestone. The distinction matters under inspection.
A Decision Defense Record for CAPA closure captures the effectiveness determination as a formal authorization event: the CAPA being closed, the regulatory and procedural basis governing closure criteria, the effectiveness evidence reviewed before the determination was made, the risk evaluation applied, the authorization rationale for closure, and the residual risk formally accepted.
The record is issued at the moment of the closure decision, locked with a verification fingerprint, and permanently attributable to the individual who made the effectiveness determination. It does not replace the CAPA record. It creates the authorization record that the CAPA record cannot contain.
Upload your CAPA closure evidence. The system drafts the effectiveness authorization record. You review, edit, and authorize. Closure is formalized at the moment of authorization.
Get the CAPA Closure Case File
Scenario-specific. Shows exactly what your authorization record is missing and what a defensible record looks like for this decision.