You are looking at a read-only demo. Everything here is fictional and the AI is simulated. You can read every page and ask the assistant questions, but nothing can be changed.Sign in with an access code to try the full workflow →
← Auditor console
ASM-0002EDMS · SOP-MFG-014-R7Quality System

SOP-MFG-014 rev 7 periodic review completed on time

Biennial review finished two weeks before the due date; no content changes required.

Open inspection evidence pack ↗

AI assessment

Simulated AI
A1
Risk level 1 · Formality A · RPN 4
Level 1 · Automated
Risk — severity × occurrence × detection
Severity2
Occurrence1
Detection2
RPN 4 → level 1
Formality — uncertainty + importance + complexity
Uncertainty0
Importance0
Complexity1
Formality A
AI confidence97%
The AI must be at least 75% confident to clear an item without a human.

AI’s reasoning (clear): Routine document review completed within its window with no changes. Matches the expected pattern exactly.

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 97%.
  • ✓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 1 named control(s) have a version in force.
  • ✓P6 · Supporting text was found1 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-QA-001 v8.0 §6.1 Periodic review
    Every controlled document is reviewed at least every two years. The review is recorded even where no change is needed.

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-QA-001 Document ControlEU GMP Ch.4 · 21 CFR 211.100

History

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

  1. Oct 26, 11:10 AMconnector.edms#11
    Record SOP-MFG-014-R7 pulled from EDMS
  2. Oct 26, 11:10 AMai.simulated#12
    AI proposed a grade of A1 (RPN 4, 97% confident) — Level 1
  3. Oct 26, 11:10 AMassurance#13
    Assurance Layer (rules v1.0.0) checked the AI proposal: passed all 8 checks
  4. Oct 26, 11:10 AMsystem#14
    Cleared automatically at Level 1 — no human needed