AiVACO · Inspection evidence pack

ASM-0010 — Autoclave IQ executed with one calibration deviation

Generated 2026-10-26 14:46:52 UTC · assembled from the live audit trail, not a template

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

1. Record

Source systemEDMS · VAL-IQ-0045
Process stageManufacturing
SummaryInstallation qualification for the new autoclave is complete; one temperature probe calibration certificate was out of date at execution.
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.

Severity4 of 4
Occurrence2 of 4
Detection2 of 4
Uncertainty2 of 2
Importance1 of 2
Complexity1 of 2
RPN (S × O × D)16
Computed gradeC3 — risk level 3, formality C (commensurate with risk)
AI confidence79%, recommendation: review (engine: simulated)
AI reasoningThe deviation may not affect the qualification outcome, but an out-of-date certificate on a critical instrument needs a documented decision.
RoutingLevel 3 — a human was required because:
  • Risk level 3 (RPN 16) 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 79%.
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 1 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
VMP-001 Validation Master Plan (IQ)EU GMP Annex 15 · ICH Q9(R1)

4. Controlled documents relied on

VMP-001 v2.0 §5.2 · Validation Master Plan — Installation qualification
IQ confirms the equipment is installed to specification. All critical instruments used during IQ must hold in-date calibration certificates; an out-of-date certificate is recorded as a deviation and assessed for impact on the qualification.
VMP-001 v2.0 §5.1 · Validation Master Plan — Qualification stages
Equipment and systems are qualified in three stages: installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ). Each stage is approved before the next begins.

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
442026-10-26 11:10:35 UTCconnector.edmsRecord VAL-IQ-0045 pulled from EDMS3e3bcd4cdd35…
452026-10-26 11:10:35 UTCai.simulatedAI proposed a grade of C3 (RPN 16, 79% confident) — Level 3ca7a2173ccfe…
462026-10-26 11:10:35 UTCassuranceAssurance Layer (rules v1.0.0) checked the AI proposal: passed all 8 checksa86bfc52352d…
472026-10-26 11:10:35 UTCsystemFlagged for a human: Risk level 3 (RPN 16) is at or above the QA threshold; The AI recommends a human review57a47d425ba2…