Completed decision record
Inspect a completed GMP decision record to see the evidence, judgment, risk, and authorization an independent reviewer should be able to find.
Inspect the completed record Check one of your own decisions
Fictitious GMP example · CAPA-2025-0118
This record answers four questions without calling the people who closed it.
Without a record
Results sit across the monitoring system, training files and audit notes. Someone has to rebuild the picture.
In this record
Four dated references are listed in one place: the monitoring trend, retraining records, SOP-EM-318 R04 and audit AUDIT-2025-031.
Open §02 Evidence ReviewedWithout a record
The reasoning lived in a meeting. The answer depends on who still remembers it.
In this record
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.
Open §04 Decision ReasoningWithout a record
Open items surface for the first time in front of the investigator.
In this record
The missing residual-risk statement is named as a gap, marked “not documented,” and accepted. It was not written in afterward.
Open §03 Risk & LimitationsWithout a record
A signature with nothing attached to explain it.
In this record
P. Trubl, Director, Quality Systems & CAPA, authorized closure on 12-AUG-2025, on the evidence listed.
Open §01 AuthorizationIllustrative structure only. Not regulatory guidance or a real company decision.
Authorization
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.
Evidence Reviewed
| 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 |
Risk & Limitations
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.
ComplianceWorxs preserves this limitation rather than generating a convenient risk statement that the source record does not support.
Decision Reasoning
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.
Audit Trail
CAPA closure record and four supporting references entered into the IRR workflow.
Residual risk statement not found in the supplied record.
Add documented information · Link evidence · Mark not documented · Route for human review.
“Mark not documented.” No unsupported language was added.
P. Trubl accepted the treatment and the limitation was preserved in the completed record.
Choose a consequential decision and ask: can the existing record show what evidence was available, how judgment was applied, what risk remained, and who authorized the outcome, without asking the original team to reconstruct it?
If yes
Your existing record may already preserve what an independent reviewer would need. No additional action may be necessary.
If uncertain
Use the Decision Documentation Assessment to determine whether your responses indicate a reason for closer examination.
If no
An Inspection Response Record can organize the available evidence and preserve the known limitations of what can, and cannot, be reconstructed.
Preserve your decision
For one completed GMP decision, ComplianceWorxs organizes the available evidence, judgment, risk, alternatives, reasoning, and authorization into an Inspection Response Record.
You receive:
If the record is created after the decision, it can organize available evidence and identify known limitations. It cannot recreate evidence that was never preserved.