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ASM-0011LMS · TRN-0322Manufacturing

Aseptic gowning requalification current for all staff

Annual gowning requalification completed for all 22 aseptic operators.

Open inspection evidence pack ↗

AI assessment

Simulated AI
A1
Risk level 1 · Formality A · RPN 6
Level 1 · Automated
Risk — severity × occurrence × detection
Severity3
Occurrence1
Detection2
RPN 6 → level 1
Formality — uncertainty + importance + complexity
Uncertainty0
Importance1
Complexity0
Formality A
AI confidence94%
The AI must be at least 75% confident to clear an item without a human.

AI’s reasoning (clear): Every operator is requalified within the last 12 months. Nothing outstanding.

Why no human was needed

Low risk, the AI was confident, and its grade met the formality ICH Q9 requires, so it was cleared at Level 1 and logged.

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 94%.
  • ✓P3 · Recommendation is one the platform allowsThe recommendation is “clear”.
  • ✓P4 · A reason is givenA reason is given.
  • ✓P5 · It rests on documents that are in force todayAll 2 named control(s) have a version in force.
  • ✓P6 · Supporting text was found2 supporting passage(s) found.
  • ✓P7 · Formality matches the riskGrade A1 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

  • SOP-MFG-031 v4.0 §3.3 Gowning qualification
    Operators in aseptic areas hold a current gowning qualification, renewed every 12 months. An operator without a current qualification does not enter the aseptic area.
  • SOP-HR-004 v6.0 §3.4 Annual refresh
    GMP training is refreshed annually. Overdue training removes the person from unsupervised GMP tasks until it is completed.

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
SOP-HR-004 GMP Training21 CFR 211.25 · EU GMP Ch.2
SOP-MFG-031 Aseptic FillingEU GMP Annex 1 · ICH Q9(R1)

History

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

  1. Oct 26, 11:10 AMconnector.lms#48
    Record TRN-0322 pulled from LMS
  2. Oct 26, 11:10 AMai.simulated#49
    AI proposed a grade of A1 (RPN 6, 94% confident) — Level 1
  3. Oct 26, 11:10 AMassurance#50
    Assurance Layer (rules v1.0.0) checked the AI proposal: passed all 8 checks
  4. Oct 26, 11:10 AMsystem#51
    Cleared automatically at Level 1 — no human needed