AiVACO · Inspection evidence pack

ASM-0007 — CAPA-2026-031 effectiveness check closed

Generated 2026-10-26 15:23:10 UTC · assembled from the live audit trail, not a template

Audit trail integrity: Intact. 68 records verified at generation time.

1. Record

Source systemEQMS · CAPA-2026-031
Process stageQuality System
SummaryEffectiveness check showed no recurrence over the 90-day monitoring period.
Current dispositionCleared automatically by the AI under the routing rules

2. AI proposal and the rules applied

The AI proposes the factors below. The grade and the routing are computed by fixed rules (ICH Q9(R1)), never by the AI.

Severity3 of 4
Occurrence2 of 4
Detection2 of 4
Uncertainty1 of 2
Importance1 of 2
Complexity1 of 2
RPN (S × O × D)12
Computed gradeB2 — risk level 2, formality B (commensurate with risk)
AI confidence90%, recommendation: clear (engine: simulated)
AI reasoningMonitoring period completed with zero recurrences and the closure evidence is attached.
RoutingLevel 2 — cleared without a human

Assurance Layer check on the AI proposal

Fixed rule set version 1.0.0, checked on 2026-10-26. Overall: passed.

RuleResultDetail
P1 · Scores are on the defined scalesPassedAll six scores are whole numbers inside their scales.
P2 · Confidence is a real percentagePassedConfidence is 90%.
P3 · Recommendation is one the platform allowsPassedThe recommendation is “clear”.
P4 · A reason is givenPassedA reason is given.
P5 · It rests on documents that are in force todayPassedAll 1 named control(s) have a version in force.
P6 · Supporting text was foundPassed2 supporting passage(s) found.
P7 · Formality matches the riskPassedGrade B2 is formal enough for the risk.
P8 · The AI did not try to lower the barPassedThe AI’s recommendation does not try to go below what the fixed rules require.

3. Controls and the regulations they satisfy

Company controlRegulation / guideline
SOP-QA-012 CAPAICH Q10 §3.2 · 21 CFR 211.192

4. Controlled documents relied on

SOP-QA-012 v5.0 §5.2 · Corrective and Preventive Action (CAPA) — Effectiveness check
An effectiveness check is defined at CAPA approval and run after a monitoring period of at least 90 days. A CAPA is closed only when the check shows no recurrence.
SOP-QA-012 v5.0 §4.1 · Corrective and Preventive Action (CAPA) — Initiation
A CAPA is raised when a deviation, audit finding or trend shows a systemic cause. Each CAPA names an owner, a due date and a risk rating under ICH Q9.

5. Signature

No signature on this assessment.

6. Audit trail for this record

Each record is hash-chained to the one before it and cannot be edited or deleted. Record numbers refer to the platform-wide trail.

#Time (UTC)WhoEventHash
322026-10-26 11:10:34 UTCconnector.eqmsRecord CAPA-2026-031 pulled from EQMS7f4d0b92ecf9…
332026-10-26 11:10:34 UTCai.simulatedAI proposed a grade of B2 (RPN 12, 90% confident) — Level 244e5810665df…
342026-10-26 11:10:35 UTCassuranceAssurance Layer (rules v1.0.0) checked the AI proposal: passed all 8 checks0f513a22fb92…
352026-10-26 11:10:35 UTCsystemCleared automatically at Level 2 — no human needed69767593a802…