AiVACO · Inspection evidence pack

ASM-0004 — GMP training current for packaging line 2 operators

Generated 2026-10-26 15:21:28 UTC · assembled from the live audit trail, not a template

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

1. Record

Source systemLMS · TRN-0310
Process stagePackaging
SummaryAll 14 operators hold in-date GMP and line-specific training.
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.

Severity2 of 4
Occurrence2 of 4
Detection2 of 4
Uncertainty1 of 2
Importance1 of 2
Complexity0 of 2
RPN (S × O × D)8
Computed gradeB2 — risk level 2, formality B (commensurate with risk)
AI confidence92%, recommendation: clear (engine: simulated)
AI reasoning100% of required training is in date. No gaps found against the training matrix.
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 92%.
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-HR-004 GMP Training21 CFR 211.25 · EU GMP Ch.2

4. Controlled documents relied on

SOP-HR-004 v6.0 §3.4 · GMP Training — Annual refresh
GMP training is refreshed annually. Overdue training removes the person from unsupervised GMP tasks until it is completed.
SOP-HR-004 v6.0 §3.1 · GMP Training — Training before tasks
No person performs a GMP task unsupervised until training on the relevant procedures is complete and recorded. Until then they work under the direct supervision of a trained person, and the supervision is recorded.

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
192026-10-26 11:10:33 UTCconnector.lmsRecord TRN-0310 pulled from LMSb74b29105d9c…
202026-10-26 11:10:33 UTCai.simulatedAI proposed a grade of B2 (RPN 8, 92% confident) — Level 2ddc38bd1116f…
212026-10-26 11:10:33 UTCassuranceAssurance Layer (rules v1.0.0) checked the AI proposal: passed all 8 checksdfab28e6bee0…
222026-10-26 11:10:34 UTCsystemCleared automatically at Level 2 — no human needed9122595ee83c…