Generated 2026-10-26 15:18:24 UTC · assembled from the live audit trail, not a template
| Source system | EDMS · SOP-MFG-014-R7 |
|---|---|
| Process stage | Quality System |
| Summary | Biennial review finished two weeks before the due date; no content changes required. |
| 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 | 2 of 4 |
|---|---|
| Occurrence | 1 of 4 |
| Detection | 2 of 4 |
| Uncertainty | 0 of 2 |
| Importance | 0 of 2 |
| Complexity | 1 of 2 |
| RPN (S × O × D) | 4 |
| Computed grade | A1 — risk level 1, formality A (commensurate with risk) |
| AI confidence | 97%, recommendation: clear (engine: simulated) |
| AI reasoning | Routine document review completed within its window with no changes. Matches the expected pattern exactly. |
| Routing | Level 1 — 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 97%. |
| 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 | 1 supporting passage(s) found. |
| P7 · Formality matches the risk | Passed | Grade A1 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-QA-001 Document Control | EU GMP Ch.4 · 21 CFR 211.100 |
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 |
|---|---|---|---|---|
| 11 | 2026-10-26 11:10:33 UTC | connector.edms | Record SOP-MFG-014-R7 pulled from EDMS | a0211e48d5cb… |
| 12 | 2026-10-26 11:10:33 UTC | ai.simulated | AI proposed a grade of A1 (RPN 4, 97% confident) — Level 1 | 40654a292592… |
| 13 | 2026-10-26 11:10:33 UTC | assurance | Assurance Layer (rules v1.0.0) checked the AI proposal: passed all 8 checks | 2931851b530d… |
| 14 | 2026-10-26 11:10:33 UTC | system | Cleared automatically at Level 1 — no human needed | 32cb9081fbd9… |