FDA Inspection Decision Scenario

Who Authorized This CAPA Closure?

“Who made the determination that this CAPA was effective, and what evidence supported that conclusion?”

21 CFR 820.100

Why this becomes difficult to defend

The decision exists. The basis for it may not be retrievable as one record.

The investigator pulls a closed CAPA from eighteen months ago. The effectiveness check is marked complete. The investigator asks who authorized the closure.

The CAPA record shows corrective action steps were completed. It does not show who evaluated the effectiveness evidence and made the formal closure authorization — or that anyone did.

What must be retrievable

The reviewer needs more than the final outcome.

  • Named decision owner for CAPA closure authorization
  • Effectiveness evidence reviewed prior to closure
  • Regulatory standard applied to the effectiveness determination
  • Authorization timestamp for the closure decision
  • Reasoning linking effectiveness data to closure justification

Relevant proof

See how the record connects evidence, judgment, risk, and authorization.

A completed ComplianceWorxs record shows the reasoning layer that is usually hardest to reconstruct after the decision has been made.

EvidenceWhat was known JudgmentHow it was evaluated RiskWhat was weighed AuthorizationWho decided and why

When this is your active decision

Preserve the reasoning before the context disappears.

Use the completed proof first. When the decision is consequential enough to preserve, create an Inspection Response Record for the actual decision.