AiVACO · Inspection evidence pack

ASM-0009 — Batch record missing a second-person verification

Generated 2026-10-26 14:49:02 UTC · assembled from the live audit trail, not a template

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

1. Record

Source systemMES · MES-MFG-0288
Process stageManufacturing
SummaryBatch 24-0888 weigh-and-dispense step has one signature; a second-person check is required.
Current dispositionFlagged, waiting for the auditor

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
Occurrence3 of 4
Detection2 of 4
Uncertainty2 of 2
Importance1 of 2
Complexity1 of 2
RPN (S × O × D)18
Computed gradeC3 — risk level 3, formality C (commensurate with risk)
AI confidence86%, recommendation: review (engine: simulated)
AI reasoningA required independent verification is absent. This is a documentation and data-integrity gap a QA reviewer must resolve.
RoutingLevel 3 — a human was required because:
  • Risk level 3 (RPN 18) is at or above the QA threshold
  • The AI recommends a human review

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 86%.
P3 · Recommendation is one the platform allowsPassedThe recommendation is “review”.
P4 · A reason is givenPassedA reason is given.
P5 · It rests on documents that are in force todayPassedAll 2 named control(s) have a version in force.
P6 · Supporting text was foundPassed2 supporting passage(s) found.
P7 · Formality matches the riskPassedGrade C3 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-MFG-014 Batch Record Review21 CFR 211.188 · EU GMP Ch.4
SOP-QA-030 Data Integrity21 CFR Part 11 · EU GMP Annex 11

4. Controlled documents relied on

SOP-MFG-014 v7.0 §6.2 · Batch Record Review — Second-person verification
Critical steps, including weighing and dispensing, require a second-person verification signed in the batch record at the time of the operation. A missing verification is a deviation and the batch is held until it is resolved.
SOP-QA-030 v3.0 §3.4 · Data Integrity — Independent verification
Where a procedure requires independent verification, the verifier is a different person from the operator and signs contemporaneously. A missing verification is treated as a data integrity gap.

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
402026-10-26 11:10:35 UTCconnector.mesRecord MES-MFG-0288 pulled from MES49a5b13ebd57…
412026-10-26 11:10:35 UTCai.simulatedAI proposed a grade of C3 (RPN 18, 86% confident) — Level 3d9d080d90943…
422026-10-26 11:10:35 UTCassuranceAssurance Layer (rules v1.0.0) checked the AI proposal: passed all 8 checksd8fc895220bc…
432026-10-26 11:10:35 UTCsystemFlagged for a human: Risk level 3 (RPN 18) is at or above the QA threshold; The AI recommends a human review7591ff82374a…