Evidence
What corrective-action and verification evidence existed.
CAPA Effectiveness Decision Record
Your CAPA may be closed. Can you show why it was safe to close?
Inspect whether the record behind CAPA closure makes the evidence, judgment, risk, and authorization visible—before an investigator asks your team to reconstruct the decision.
Built for QA Directors · VP Quality · Regulatory Affairs · Site and Manufacturing Quality leaders responsible for CAPA closure and inspection readiness.
The closure record
A closed CAPA is more than a closure date.
A reviewer must be able to see what corrective-action and verification evidence existed, how effectiveness was evaluated, what residual risk or uncertainty remained, and who authorized the conclusion.
Judgment
How effectiveness was evaluated against stated criteria.
Risk
What residual risk, uncertainty, or recurrence exposure remained.
[]
Authorization
Who accepted the effectiveness conclusion and why.
The closure exposure
The CAPA may be complete. Its effectiveness basis may not be recoverable.
EVIDENCE
Verification and implementation evidence incomplete
JUDGMENT
Effectiveness criteria not linked to conclusion
DECISION RECORD
CAPA Effectiveness
Decision Record
Decision Record
Record statusCLOSED
DecisionCAPA effective
AuthorityQuality review
RISK
Recurrence and residual-risk basis unclear
[]AUTHORIZATION
Closure authority not recorded
A CAPA plan, completion evidence, and closure signature can all exist while the reason for accepting effectiveness remains distributed, incomplete, or dependent on later reconstruction.
01
Inspection response risk
Can the team show how effectiveness was determined when an investigator asks?
02
Recurrence risk
Can leadership show that corrective action addressed the actual root cause—not only the observed event?
03
Authorization gap
Can the organization show who accepted the effectiveness conclusion and what evidence supported that authority?
The basis cannot be reconstructed clearlyA closed CAPA can leave its Evidence, Judgment, Risk, and Authorization dispersed across records that no longer connect.
See the actual opening view
Inspect the Case File before you buy.
The preview now begins with the actual Executive Case File interface—including the left-hand decision path that organizes the artifact—then lets you inspect selected Evidence, Judgment, Risk, and Authorization content.
Actual opening interface · Selected decision sections · No email required
Built for CAPA closure accountability
For leaders who must defend the conclusion—not simply approve the workflow.
Use the Case File to pressure-test whether your closure records would let an independent reviewer reconstruct the decision without relying on memory, assumptions, or scattered documentation.
QA Directors and VP Quality accountable for whether closure reflects actual control.
Regulatory Affairs leaders preparing to explain CAPA effectiveness under inspection scrutiny.
Site and Manufacturing Quality leaders responsible for evidence, execution, and sustained effectiveness.
CAPA Effectiveness Case File
Before the investigator asks how effectiveness was determined, inspect the record behind closure.
A completed, scenario-specific decision record showing the evidence, judgment, risk, and authorization behind a defensible CAPA effectiveness conclusion.
$149 one completed worked example
Immediate access after successful checkout