Generated 2026-10-26 15:23:37 UTC · assembled from the live audit trail, not a template
| Source system | LIMS · STAB-23-114-12M |
|---|---|
| Process stage | Research & Development |
| Summary | All attributes within limits; assay trend flat; no out-of-trend signals. |
| Current disposition | Cleared automatically by the AI under the routing rules |
The AI proposes the factors below. The grade and the routing are computed by fixed rules (ICH Q9(R1)), never by the AI.
| Severity | 3 of 4 |
|---|---|
| Occurrence | 1 of 4 |
| Detection | 3 of 4 |
| Uncertainty | 1 of 2 |
| Importance | 1 of 2 |
| Complexity | 0 of 2 |
| RPN (S × O × D) | 9 |
| Computed grade | B2 — risk level 2, formality B (commensurate with risk) |
| AI confidence | 93%, recommendation: clear (engine: simulated) |
| AI reasoning | Results sit within limits and show no adverse trend versus earlier timepoints. |
| Routing | Level 2 — cleared without a human |
Fixed rule set version 1.0.0, checked on 2026-10-26. Overall: passed.
| Rule | Result | Detail |
|---|---|---|
| P1 · Scores are on the defined scales | Passed | All six scores are whole numbers inside their scales. |
| P2 · Confidence is a real percentage | Passed | Confidence is 93%. |
| P3 · Recommendation is one the platform allows | Passed | The recommendation is “clear”. |
| P4 · A reason is given | Passed | A reason is given. |
| P5 · It rests on documents that are in force today | Passed | All 1 named control(s) have a version in force. |
| P6 · Supporting text was found | Passed | 2 supporting passage(s) found. |
| P7 · Formality matches the risk | Passed | Grade B2 is formal enough for the risk. |
| P8 · The AI did not try to lower the bar | Passed | The AI’s recommendation does not try to go below what the fixed rules require. |
| Company control | Regulation / guideline |
|---|---|
| SOP-QC-009 Stability Program | ICH Q1A(R2) · 21 CFR 211.166 |
No signature on this assessment.
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) | Who | Event | Hash |
|---|---|---|---|---|
| 36 | 2026-10-26 11:10:35 UTC | connector.lims | Record STAB-23-114-12M pulled from LIMS | 8f431eaad25e… |
| 37 | 2026-10-26 11:10:35 UTC | ai.simulated | AI proposed a grade of B2 (RPN 9, 93% confident) — Level 2 | ba31497c70d2… |
| 38 | 2026-10-26 11:10:35 UTC | assurance | Assurance Layer (rules v1.0.0) checked the AI proposal: passed all 8 checks | d8c690a57013… |
| 39 | 2026-10-26 11:10:35 UTC | system | Cleared automatically at Level 2 — no human needed | aea4c3af7382… |