Built for consequential GMP decisions
Focused on the evidence, judgment, risk, and authorization a later reviewer may need to understand.
CAPA & QUALITY MANAGEMENT
CAPA Effectiveness
Case File
A closed CAPA shows the actions were completed. Use this worked case to identify gaps in your CAPA closure record and see how the basis for closure can be made clear.
Scenario-specificCompleted worked example
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Decision trailEvidence through authorization
THE CLOSURE DECISION
Your CAPA may be closed. Can you show why it was safe to close?
This executive Case File helps Quality leaders test whether the evidence, judgment, residual uncertainty, and accountable authorization behind CAPA closure can still be retrieved later.
CAPA EFFECTIVENESS DECISION · EXECUTIVE REFERENCE
Closure Decision Record
CLOSEDDECISION CAPA effective — close
EVIDENCE Implementation, verification, trend, and contrary-signal review
JUDGMENT Criteria met within a defined observation window
AUTHORIZATION Quality authority accepts conclusion and remaining uncertainty
DOES THIS SOUND FAMILIAR?
A closed CAPA is not the same decision as the review behind it.
Most CAPA procedures cover the steps: root cause, actions, effectiveness check, closure. They do not make the closure record explain why the CAPA was judged effective. If any of these describe your closed CAPAs, the Case File shows what a record that answers them looks like.
- Closed on the strength of completed actions and a signature.
- Success criteria written, or reconstructed, after the data was in.
- Nobody can say who concluded “effective,” and on what data, without calling the person who closed it.
- Other batches or products on the same equipment checked after closure, or not at all.
- If it recurred tomorrow, the firm would have to explain a decision it cannot show it reasoned through.
Your SOP defines the process. This Case File shows what the decision looks like when the process meets a difficult situation.
WHAT'S INSIDE
The record behind the closure decision.
The CAPA Effectiveness Case File is an illustrative scenario and a completed worked record, showing how a later reviewer could follow a closure decision without reconstructing the reasoning from scattered records. The firm, product and people are fictional.
- An illustrative inspection scenario: a signed “CAPA effective” closure, then recurrence, and no record of why anyone judged it effective
- The decision-record test, with the rules behind it and guidance kept separate from regulation
- A completed worked record: what the evidence established versus what was only inferred, judgment, risk and alternatives, authorization
- Why the success criterion and monitoring period were chosen, and what scope questions were settled before closure
- The residual items carried forward, who owns them, and the trigger that reopens the CAPA
- A side-by-side comparison: four questions, where the worked record answers each, and what to do when your own record does not
ComplianceWorxs
FROM THE WORKED RECORD
How the record documents why the criterion and period were chosen.
This section comes from the worked example: a CAPA for a recurring coating defect, closed as effective after six lots. It is shown as written. The product, CAPA and people are fictional.
Why this criterion
The criterion was a defect rate at or below 0.10% on each of six consecutive lots. The 12-month pre-drift rate was 0.02% to 0.06%, and the excursion period ran 0.31% to 0.47%, so 0.10% sits above normal variation and well below the excursion range.
Why this period
The cause was drift over time, so the window had to span more than two full calibration intervals. Six lots covered about three.
Use it on your own closures. Say where your criterion came from, in normal performance and not a round number. Show it was set before the data. Match the window to how the failure happens.
A worked example for illustration. It is not legal, regulatory or quality advice, and not a regulatory determination. Case File purchases are final and non-refundable. The Terms of Service apply.
Made to be inspected
A completed worked example lets Quality leaders see how the reasoning can be preserved—not just described.
Useful before you need it
See the structure now, then decide whether a Case File, Review Kit, or IRR fits the job you actually have.
A COMPLETED EXAMPLE. NOT A TEMPLATE BUNDLE.
Inspect the finished record before you need to explain your own decision.
The Case File is a scenario-specific reference artifact. It does not replace your QMS or make the CAPA decision for you. To see where your own closed CAPAs stand, the 3-minute Decision Documentation Assessment is free. For one consequential decision, the Inspection Response Record ($497) is built from your own evidence, and your $149 applies to it.
✓ Your $149 applies to the $497 IRR ✓ Secure Stripe checkout ✓ Delivered after payment ✓ Recovery path preserved