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ASM-0010EDMS · VAL-IQ-0045Manufacturing

Autoclave IQ executed with one calibration deviation

Installation qualification for the new autoclave is complete; one temperature probe calibration certificate was out of date at execution.

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AI assessment

Simulated AI
C3
Risk level 3 · Formality C · RPN 16
Level 3 · Human review
Risk — severity × occurrence × detection
Severity4
Occurrence2
Detection2
RPN 16 → level 3
Formality — uncertainty + importance + complexity
Uncertainty2
Importance1
Complexity1
Formality C
AI confidence79%
The AI must be at least 75% confident to clear an item without a human.

AI’s reasoning (review): The deviation may not affect the qualification outcome, but an out-of-date certificate on a critical instrument needs a documented decision.

Why a human is involved

  • Risk level 3 (RPN 16) is at or above the QA threshold
  • The AI recommends a human review

These reasons come from fixed rules, not from the AI. The AI can add reasons for a human to look but can never remove them.

Checked by the Assurance Layer

Checked, passedAll 8 Assurance checks on this proposal
  • ✓P1 · Scores are on the defined scalesAll six scores are whole numbers inside their scales.
  • ✓P2 · Confidence is a real percentageConfidence is 79%.
  • ✓P3 · Recommendation is one the platform allowsThe recommendation is “review”.
  • ✓P4 · A reason is givenA reason is given.
  • ✓P5 · It rests on documents that are in force todayAll 1 named control(s) have a version in force.
  • ✓P6 · Supporting text was found2 supporting passage(s) found.
  • ✓P7 · Formality matches the riskGrade C3 is formal enough for the risk.
  • ✓P8 · The AI did not try to lower the barThe AI’s recommendation does not try to go below what the fixed rules require.

Rule set v1.0.0, judged on 2026-10-26. See the rules

Before the AI’s proposal is used, fixed rules check it. A failed blocking rule means the AI cannot clear the item by itself.

Grounded in the controlled documents

  • VMP-001 v2.0 §5.2 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 All critical instruments used during IQ must hold in-date calibration certificates; an out-of-date certificate is recorded as a deviation and assessed for impact on the qualification.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 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.

Only approved, effective versions are quoted, and only documents this record is mapped to. The assistant cites the same sections.

Controls and the regulations they satisfy

Company controlRegulation / guideline
VMP-001 Validation Master Plan (IQ)EU GMP Annex 15 · ICH Q9(R1)

History

Every step below is a record in the tamper-evident audit trail.

  1. Oct 26, 11:10 AMconnector.edms#44
    Record VAL-IQ-0045 pulled from EDMS
  2. Oct 26, 11:10 AMai.simulated#45
    AI proposed a grade of C3 (RPN 16, 79% confident) — Level 3
  3. Oct 26, 11:10 AMassurance#46
    Assurance Layer (rules v1.0.0) checked the AI proposal: passed all 8 checks
  4. Oct 26, 11:10 AMsystem#47
    Flagged for a human: Risk level 3 (RPN 16) is at or above the QA threshold; The AI recommends a human review