See one record answer the inspector
When the inspector asks why this CAPA was closed, the answer should already be in the record.
Watch 80 seconds, then follow the same decision yourself: the evidence, the judgment, the risk and the authorization behind it.
Fictitious example. No upload, registration or purchase needed.
Now do it yourself
Four questions an investigator will ask. Find the answer in the record.
At each step, reveal what the record shows. Light up all four.
0 of 4 answered from the record
The problem
Eighteen months later, an investigator asks why this CAPA was closed.
The recorded outcome · abbreviated view of the illustrative record
| Record | CAPA-2025-0118 |
|---|---|
| Status | Closed |
| Authorized by | P. Trubl, Director, Quality Systems & CAPA |
| Date | 12-AUG-2025 |
This tells you what was decided and by whom. It does not answer the investigator’s four questions:
- What did you know when you closed it?
- Why was 90 days enough?
- What did you knowingly leave open?
- Who accepted it, and on what basis?
It shows how much reasoning is visible in this view. A short view is not necessarily noncompliant, and information left out of a view may exist elsewhere.
Step 1 of 4 · Evidence
What did you know when you closed it?
Results sit across the monitoring system, training files and audit notes. Someone has to rebuild the picture.
Four dated references are listed in one place: the monitoring trend, retraining records, SOP-EM-318 R04 and audit AUDIT-2025-031.
From the record
| Evidence | Reference | What it supports |
|---|---|---|
| Environmental-monitoring trend | EM-DAILY · 14-MAY–12-AUG | No recurrence across the verification window |
| Analyst retraining records | TRAIN-EM · 02-MAY | Corrective action implemented |
| Revised procedure | SOP-EM-318 R04 | Procedural control in force |
| Internal audit observation | AUDIT-2025-031 · 18-JUL | Observed compliant execution at day 65 |
What to noticeFour dated references, each listed with what it supports.
Source: Sample record §02 Evidence Reviewed
Step 2 of 4 · Judgment
Why was 90 days enough?
The reasoning lived in a meeting. The answer depends on who still remembers it.
Closure rested on four findings agreeing, not on 90 quiet days alone: no repeat excursion, retraining, the revised procedure, and an independent audit at day 65.
From the record
The authorization relied on convergence rather than absence of recurrence alone. The monitoring trend showed no repeat excursion during the effectiveness window; the analyst population had completed retraining; the revised procedure was in force; and the internal audit provided an independent observation that the revised process was being followed.
The record therefore supports the conclusion that the corrective action was operating as intended during the documented period. It does not establish conditions outside that period, and the missing residual-risk statement remains a known limitation of the source record.
What to noticeThe record states the limit of its own conclusion: it does not establish conditions outside the documented period.
Source: Sample record §04 Decision Reasoning
Step 3 of 4 · Risk
What did you knowingly leave open?
Open items surface for the first time in front of the investigator.
The missing residual-risk statement is named as a gap, marked “not documented,” and accepted. It was not written in afterward.
From the record
The original CAPA record concluded that the corrective action was effective but did not state what uncertainty remained after closure or what residual risk was being accepted.
Treatment selected: Mark as not documented · Accepted by: P. Trubl · 12-AUG-2025 14:32
What to noticeThe gap is named and accepted by a person. It is not written in afterward.
Source: Sample record §03 Risk & Limitations; §05 Audit Trail (14:24 to 14:32)
Step 4 of 4 · Authorization
Who accepted it, and on what basis?
A signature with nothing attached to explain it.
P. Trubl, Director, Quality Systems & CAPA, authorized closure on 12-AUG-2025, on the evidence listed.
From the record
P. Trubl authorized closure of CAPA-2025-0118 after the defined effectiveness window. The submitted record showed zero recurrence during the 90-day environmental-monitoring period, completion of analyst retraining, implementation of SOP-EM-318 R04, and a day-65 internal audit observation confirming execution of the revised procedure.
Role: Director, Quality Systems & CAPA · Decision date: 12-AUG-2025 · Originating record: DEV-2025-0042 · Recorded conditions: none recorded in this sample
What to noticeA named role and date, tied to the originating record DEV-2025-0042.
Source: Sample record §01 Authorization
Four of four
You’ve followed one decision through all four lenses.
You started with the recorded outcome and the investigator’s four questions. The record answered each one without calling anyone in, and it named what was not documented instead of covering it.
For your own decision
You provide one completed decision and the evidence you have.
The $497 IRR
Organizes it to answer the same four questions and states what is missing. It cannot recreate evidence that was never preserved.
Create an IRR for your decision · $497 → Open the complete sample record →
Why it matters
When the reasoning is hard to find, the time goes somewhere.
In general, when the reasoning behind a decision is incomplete or hard to retrieve, an organization may spend time on:
- Locating the supporting evidence.
- Interrupting subject-matter experts to explain what they meant.
- Reconstructing the rationale after the fact.
- Taking management review time.
- Preparing for an inspection.
These are general possibilities, not results shown by the example above. A gap in the reasoning does not by itself mean a regulatory finding.