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Audit trail
Every record, in order, provably unbroken.
Append-only, hash-chained e-records (REQ-001–003). This page reads directly from the running API — nothing here is mocked or cached.
Chain status
✓ Chain intact — 68 record(s) checked
Records (68)
| # | Time | Actor | Event | Payload | Prev hash | Hash |
|---|---|---|---|---|---|---|
| 1 | 11:10:32 AM | system | SYSTEM_CONNECTED | {"systemCode":"EQMS","name":"Electronic Quality Management System","simulated":true} | 0000000000… | 27bd3894f9… |
| 2 | 11:10:32 AM | system | SYSTEM_CONNECTED | {"systemCode":"EDMS","name":"Electronic Document Management System","simulated":true} | 27bd3894f9… | 53695e27cc… |
| 3 | 11:10:32 AM | system | SYSTEM_CONNECTED | {"systemCode":"ERP","name":"Enterprise Resource Planning","simulated":true} | 53695e27cc… | 6da73cfcab… |
| 4 | 11:10:32 AM | system | SYSTEM_CONNECTED | {"systemCode":"MES","name":"Manufacturing Execution System","simulated":true} | 6da73cfcab… | ad8c7156bc… |
| 5 | 11:10:32 AM | system | SYSTEM_CONNECTED | {"systemCode":"LIMS","name":"Laboratory Information Management System","simulated":true} | ad8c7156bc… | f55df74d84… |
| 6 | 11:10:32 AM | system | SYSTEM_CONNECTED | {"systemCode":"LMS","name":"Learning Management System","simulated":true} | f55df74d84… | d2a17f980f… |
| 7 | 11:10:32 AM | connector.eqms | RECORD_INGESTED | {"assessmentCode":"ASM-0001","systemCode":"EQMS","sourceRef":"DEV-2026-0142","requestedBy":"system","simulated":true} | d2a17f980f… | 97f74b97cf… |
| 8 | 11:10:32 AM | ai.simulated | AI_ASSESSED | {"assessmentCode":"ASM-0001","factors":{"severity":4,"occurrence":2,"detection":2,"uncertainty":1,"importance":2,"complexity":1},"confidence":0.88,"recommendation":"review","rpn":16,"grade":"C3","level":3,"simulated":true} | 97f74b97cf… | 7479fd0cd6… |
| 9 | 11:10:33 AM | assurance | ASSURANCE_CHECKED | {"assessmentCode":"ASM-0001","report":{"rulesetVersion":"1.0.0","subject":"proposal","outcome":"passed","checkedOn":"2026-10-26","results":[{"ruleId":"P1","name":"Scores are on the defined scales","severity":"blocking","passed":true,"detail":"All six scores are whole numbers inside their scales."},{"ruleId":"P2","name":"Confidence is a real percentage","severity":"blocking","passed":true,"detail":"Confidence is 88%."},{"ruleId":"P3","name":"Recommendation is one the platform allows","severity":"blocking","passed":true,"detail":"The recommendation is “review”."},{"ruleId":"P4","name":"A reason is given","severity":"blocking","passed":true,"detail":"A reason is given."},{"ruleId":"P5","name":"It rests on documents that are in force today","severity":"blocking","passed":true,"detail":"All 2 named control(s) have a version in force."},{"ruleId":"P6","name":"Supporting text was found","severity":"warning","passed":true,"detail":"2 supporting passage(s) found."},{"ruleId":"P7","name":"Formality matches the risk","severity":"warning","passed":true,"detail":"Grade C3 is formal enough for the risk."},{"ruleId":"P8","name":"The AI did not try to lower the bar","severity":"warning","passed":true,"detail":"The AI’s recommendation does not try to go below what the fixed rules require."}]}} | 7479fd0cd6… | a412fe110c… |
| 10 | 11:10:33 AM | system | ASSESSMENT_FLAGGED | {"assessmentCode":"ASM-0001","level":3,"reasons":["Risk level 3 (RPN 16) is at or above the QA threshold","The AI recommends a human review"]} | a412fe110c… | a7d48a9d63… |
| 11 | 11:10:33 AM | connector.edms | RECORD_INGESTED | {"assessmentCode":"ASM-0002","systemCode":"EDMS","sourceRef":"SOP-MFG-014-R7","requestedBy":"system","simulated":true} | a7d48a9d63… | a0211e48d5… |
| 12 | 11:10:33 AM | ai.simulated | AI_ASSESSED | {"assessmentCode":"ASM-0002","factors":{"severity":2,"occurrence":1,"detection":2,"uncertainty":0,"importance":0,"complexity":1},"confidence":0.97,"recommendation":"clear","rpn":4,"grade":"A1","level":1,"simulated":true} | a0211e48d5… | 40654a2925… |
| 13 | 11:10:33 AM | assurance | ASSURANCE_CHECKED | {"assessmentCode":"ASM-0002","report":{"rulesetVersion":"1.0.0","subject":"proposal","outcome":"passed","checkedOn":"2026-10-26","results":[{"ruleId":"P1","name":"Scores are on the defined scales","severity":"blocking","passed":true,"detail":"All six scores are whole numbers inside their scales."},{"ruleId":"P2","name":"Confidence is a real percentage","severity":"blocking","passed":true,"detail":"Confidence is 97%."},{"ruleId":"P3","name":"Recommendation is one the platform allows","severity":"blocking","passed":true,"detail":"The recommendation is “clear”."},{"ruleId":"P4","name":"A reason is given","severity":"blocking","passed":true,"detail":"A reason is given."},{"ruleId":"P5","name":"It rests on documents that are in force today","severity":"blocking","passed":true,"detail":"All 1 named control(s) have a version in force."},{"ruleId":"P6","name":"Supporting text was found","severity":"warning","passed":true,"detail":"1 supporting passage(s) found."},{"ruleId":"P7","name":"Formality matches the risk","severity":"warning","passed":true,"detail":"Grade A1 is formal enough for the risk."},{"ruleId":"P8","name":"The AI did not try to lower the bar","severity":"warning","passed":true,"detail":"The AI’s recommendation does not try to go below what the fixed rules require."}]}} | 40654a2925… | 2931851b53… |
| 14 | 11:10:33 AM | system | ASSESSMENT_AUTO_CLEARED | {"assessmentCode":"ASM-0002","level":1} | 2931851b53… | 32cb9081fb… |
| 15 | 11:10:33 AM | connector.lims | RECORD_INGESTED | {"assessmentCode":"ASM-0003","systemCode":"LIMS","sourceRef":"BATCH-24-0871-ASSAY","requestedBy":"system","simulated":true} | 32cb9081fb… | 14eb069a75… |
| 16 | 11:10:33 AM | ai.simulated | AI_ASSESSED | {"assessmentCode":"ASM-0003","factors":{"severity":3,"occurrence":1,"detection":2,"uncertainty":0,"importance":1,"complexity":0},"confidence":0.95,"recommendation":"clear","rpn":6,"grade":"A1","level":1,"simulated":true} | 14eb069a75… | bdcb284037… |
| 17 | 11:10:33 AM | assurance | ASSURANCE_CHECKED | {"assessmentCode":"ASM-0003","report":{"rulesetVersion":"1.0.0","subject":"proposal","outcome":"passed","checkedOn":"2026-10-26","results":[{"ruleId":"P1","name":"Scores are on the defined scales","severity":"blocking","passed":true,"detail":"All six scores are whole numbers inside their scales."},{"ruleId":"P2","name":"Confidence is a real percentage","severity":"blocking","passed":true,"detail":"Confidence is 95%."},{"ruleId":"P3","name":"Recommendation is one the platform allows","severity":"blocking","passed":true,"detail":"The recommendation is “clear”."},{"ruleId":"P4","name":"A reason is given","severity":"blocking","passed":true,"detail":"A reason is given."},{"ruleId":"P5","name":"It rests on documents that are in force today","severity":"blocking","passed":true,"detail":"All 1 named control(s) have a version in force."},{"ruleId":"P6","name":"Supporting text was found","severity":"warning","passed":true,"detail":"2 supporting passage(s) found."},{"ruleId":"P7","name":"Formality matches the risk","severity":"warning","passed":true,"detail":"Grade A1 is formal enough for the risk."},{"ruleId":"P8","name":"The AI did not try to lower the bar","severity":"warning","passed":true,"detail":"The AI’s recommendation does not try to go below what the fixed rules require."}]}} | bdcb284037… | 7a3b9705ef… |
| 18 | 11:10:33 AM | system | ASSESSMENT_AUTO_CLEARED | {"assessmentCode":"ASM-0003","level":1} | 7a3b9705ef… | 01017bedf8… |
| 19 | 11:10:33 AM | connector.lms | RECORD_INGESTED | {"assessmentCode":"ASM-0004","systemCode":"LMS","sourceRef":"TRN-0310","requestedBy":"system","simulated":true} | 01017bedf8… | b74b29105d… |
| 20 | 11:10:33 AM | ai.simulated | AI_ASSESSED | {"assessmentCode":"ASM-0004","factors":{"severity":2,"occurrence":2,"detection":2,"uncertainty":1,"importance":1,"complexity":0},"confidence":0.92,"recommendation":"clear","rpn":8,"grade":"B2","level":2,"simulated":true} | b74b29105d… | ddc38bd111… |
| 21 | 11:10:33 AM | assurance | ASSURANCE_CHECKED | {"assessmentCode":"ASM-0004","report":{"rulesetVersion":"1.0.0","subject":"proposal","outcome":"passed","checkedOn":"2026-10-26","results":[{"ruleId":"P1","name":"Scores are on the defined scales","severity":"blocking","passed":true,"detail":"All six scores are whole numbers inside their scales."},{"ruleId":"P2","name":"Confidence is a real percentage","severity":"blocking","passed":true,"detail":"Confidence is 92%."},{"ruleId":"P3","name":"Recommendation is one the platform allows","severity":"blocking","passed":true,"detail":"The recommendation is “clear”."},{"ruleId":"P4","name":"A reason is given","severity":"blocking","passed":true,"detail":"A reason is given."},{"ruleId":"P5","name":"It rests on documents that are in force today","severity":"blocking","passed":true,"detail":"All 1 named control(s) have a version in force."},{"ruleId":"P6","name":"Supporting text was found","severity":"warning","passed":true,"detail":"2 supporting passage(s) found."},{"ruleId":"P7","name":"Formality matches the risk","severity":"warning","passed":true,"detail":"Grade B2 is formal enough for the risk."},{"ruleId":"P8","name":"The AI did not try to lower the bar","severity":"warning","passed":true,"detail":"The AI’s recommendation does not try to go below what the fixed rules require."}]}} | ddc38bd111… | dfab28e6be… |
| 22 | 11:10:34 AM | system | ASSESSMENT_AUTO_CLEARED | {"assessmentCode":"ASM-0004","level":2} | dfab28e6be… | 9122595ee8… |
| 23 | 11:10:34 AM | connector.mes | RECORD_INGESTED | {"assessmentCode":"ASM-0005","systemCode":"MES","sourceRef":"MES-PKG-0553","requestedBy":"system","simulated":true} | 9122595ee8… | 3b1fe88cc3… |
| 24 | 11:10:34 AM | ai.simulated | AI_ASSESSED | {"assessmentCode":"ASM-0005","factors":{"severity":4,"occurrence":2,"detection":3,"uncertainty":2,"importance":2,"complexity":2},"confidence":0.81,"recommendation":"escalate","rpn":24,"grade":"D4","level":3,"simulated":true} | 3b1fe88cc3… | 82b1198d13… |
| 25 | 11:10:34 AM | assurance | ASSURANCE_CHECKED | {"assessmentCode":"ASM-0005","report":{"rulesetVersion":"1.0.0","subject":"proposal","outcome":"passed","checkedOn":"2026-10-26","results":[{"ruleId":"P1","name":"Scores are on the defined scales","severity":"blocking","passed":true,"detail":"All six scores are whole numbers inside their scales."},{"ruleId":"P2","name":"Confidence is a real percentage","severity":"blocking","passed":true,"detail":"Confidence is 81%."},{"ruleId":"P3","name":"Recommendation is one the platform allows","severity":"blocking","passed":true,"detail":"The recommendation is “escalate”."},{"ruleId":"P4","name":"A reason is given","severity":"blocking","passed":true,"detail":"A reason is given."},{"ruleId":"P5","name":"It rests on documents that are in force today","severity":"blocking","passed":true,"detail":"All 2 named control(s) have a version in force."},{"ruleId":"P6","name":"Supporting text was found","severity":"warning","passed":true,"detail":"2 supporting passage(s) found."},{"ruleId":"P7","name":"Formality matches the risk","severity":"warning","passed":true,"detail":"Grade D4 is formal enough for the risk."},{"ruleId":"P8","name":"The AI did not try to lower the bar","severity":"warning","passed":true,"detail":"The AI’s recommendation does not try to go below what the fixed rules require."}]}} | 82b1198d13… | a1f14af85b… |
| 26 | 11:10:34 AM | system | ASSESSMENT_FLAGGED | {"assessmentCode":"ASM-0005","level":3,"reasons":["Risk level 4 (RPN 24) is at or above the QA threshold","The AI recommends escalation"]} | a1f14af85b… | e89b6667ec… |
| 27 | 11:10:34 AM | connector.erp | RECORD_INGESTED | {"assessmentCode":"ASM-0006","systemCode":"ERP","sourceRef":"PO-88213","requestedBy":"system","simulated":true} | e89b6667ec… | 7d2cbb82f3… |
| 28 | 11:10:34 AM | ai.simulated | AI_ASSESSED | {"assessmentCode":"ASM-0006","factors":{"severity":4,"occurrence":3,"detection":2,"uncertainty":2,"importance":2,"complexity":2},"confidence":0.62,"recommendation":"request_input","rpn":24,"grade":"D4","level":3,"simulated":true} | 7d2cbb82f3… | 51c15bd9ae… |
| 29 | 11:10:34 AM | assurance | ASSURANCE_CHECKED | {"assessmentCode":"ASM-0006","report":{"rulesetVersion":"1.0.0","subject":"proposal","outcome":"passed","checkedOn":"2026-10-26","results":[{"ruleId":"P1","name":"Scores are on the defined scales","severity":"blocking","passed":true,"detail":"All six scores are whole numbers inside their scales."},{"ruleId":"P2","name":"Confidence is a real percentage","severity":"blocking","passed":true,"detail":"Confidence is 62%."},{"ruleId":"P3","name":"Recommendation is one the platform allows","severity":"blocking","passed":true,"detail":"The recommendation is “request_input”."},{"ruleId":"P4","name":"A reason is given","severity":"blocking","passed":true,"detail":"A reason is given."},{"ruleId":"P5","name":"It rests on documents that are in force today","severity":"blocking","passed":true,"detail":"All 1 named control(s) have a version in force."},{"ruleId":"P6","name":"Supporting text was found","severity":"warning","passed":true,"detail":"2 supporting passage(s) found."},{"ruleId":"P7","name":"Formality matches the risk","severity":"warning","passed":true,"detail":"Grade D4 is formal enough for the risk."},{"ruleId":"P8","name":"The AI did not try to lower the bar","severity":"warning","passed":true,"detail":"The AI’s recommendation does not try to go below what the fixed rules require."}]}} | 51c15bd9ae… | 6284092400… |
| 30 | 11:10:34 AM | system | ASSESSMENT_FLAGGED | {"assessmentCode":"ASM-0006","level":3,"reasons":["Risk level 4 (RPN 24) is at or above the QA threshold","AI confidence 62% is below the 75% needed to clear it alone","The AI needs information from the team"]} | 6284092400… | 719a6922ac… |
| 31 | 11:10:34 AM | ai.simulated | TEAM_INPUT_REQUESTED | {"assessmentCode":"ASM-0006","requestId":"7bfa8bba-e43c-4762-b2b0-d67c13174210","question":"Has a supplier qualification audit or questionnaire been completed for Northfield Excipients Ltd? If yes, please give the reference.","assignedTo":"Supplier Quality"} | 719a6922ac… | 69a7bd9716… |
| 32 | 11:10:34 AM | connector.eqms | RECORD_INGESTED | {"assessmentCode":"ASM-0007","systemCode":"EQMS","sourceRef":"CAPA-2026-031","requestedBy":"system","simulated":true} | 69a7bd9716… | 7f4d0b92ec… |
| 33 | 11:10:34 AM | ai.simulated | AI_ASSESSED | {"assessmentCode":"ASM-0007","factors":{"severity":3,"occurrence":2,"detection":2,"uncertainty":1,"importance":1,"complexity":1},"confidence":0.9,"recommendation":"clear","rpn":12,"grade":"B2","level":2,"simulated":true} | 7f4d0b92ec… | 44e5810665… |
| 34 | 11:10:35 AM | assurance | ASSURANCE_CHECKED | {"assessmentCode":"ASM-0007","report":{"rulesetVersion":"1.0.0","subject":"proposal","outcome":"passed","checkedOn":"2026-10-26","results":[{"ruleId":"P1","name":"Scores are on the defined scales","severity":"blocking","passed":true,"detail":"All six scores are whole numbers inside their scales."},{"ruleId":"P2","name":"Confidence is a real percentage","severity":"blocking","passed":true,"detail":"Confidence is 90%."},{"ruleId":"P3","name":"Recommendation is one the platform allows","severity":"blocking","passed":true,"detail":"The recommendation is “clear”."},{"ruleId":"P4","name":"A reason is given","severity":"blocking","passed":true,"detail":"A reason is given."},{"ruleId":"P5","name":"It rests on documents that are in force today","severity":"blocking","passed":true,"detail":"All 1 named control(s) have a version in force."},{"ruleId":"P6","name":"Supporting text was found","severity":"warning","passed":true,"detail":"2 supporting passage(s) found."},{"ruleId":"P7","name":"Formality matches the risk","severity":"warning","passed":true,"detail":"Grade B2 is formal enough for the risk."},{"ruleId":"P8","name":"The AI did not try to lower the bar","severity":"warning","passed":true,"detail":"The AI’s recommendation does not try to go below what the fixed rules require."}]}} | 44e5810665… | 0f513a22fb… |
| 35 | 11:10:35 AM | system | ASSESSMENT_AUTO_CLEARED | {"assessmentCode":"ASM-0007","level":2} | 0f513a22fb… | 69767593a8… |
| 36 | 11:10:35 AM | connector.lims | RECORD_INGESTED | {"assessmentCode":"ASM-0008","systemCode":"LIMS","sourceRef":"STAB-23-114-12M","requestedBy":"system","simulated":true} | 69767593a8… | 8f431eaad2… |
| 37 | 11:10:35 AM | ai.simulated | AI_ASSESSED | {"assessmentCode":"ASM-0008","factors":{"severity":3,"occurrence":1,"detection":3,"uncertainty":1,"importance":1,"complexity":0},"confidence":0.93,"recommendation":"clear","rpn":9,"grade":"B2","level":2,"simulated":true} | 8f431eaad2… | ba31497c70… |
| 38 | 11:10:35 AM | assurance | ASSURANCE_CHECKED | {"assessmentCode":"ASM-0008","report":{"rulesetVersion":"1.0.0","subject":"proposal","outcome":"passed","checkedOn":"2026-10-26","results":[{"ruleId":"P1","name":"Scores are on the defined scales","severity":"blocking","passed":true,"detail":"All six scores are whole numbers inside their scales."},{"ruleId":"P2","name":"Confidence is a real percentage","severity":"blocking","passed":true,"detail":"Confidence is 93%."},{"ruleId":"P3","name":"Recommendation is one the platform allows","severity":"blocking","passed":true,"detail":"The recommendation is “clear”."},{"ruleId":"P4","name":"A reason is given","severity":"blocking","passed":true,"detail":"A reason is given."},{"ruleId":"P5","name":"It rests on documents that are in force today","severity":"blocking","passed":true,"detail":"All 1 named control(s) have a version in force."},{"ruleId":"P6","name":"Supporting text was found","severity":"warning","passed":true,"detail":"2 supporting passage(s) found."},{"ruleId":"P7","name":"Formality matches the risk","severity":"warning","passed":true,"detail":"Grade B2 is formal enough for the risk."},{"ruleId":"P8","name":"The AI did not try to lower the bar","severity":"warning","passed":true,"detail":"The AI’s recommendation does not try to go below what the fixed rules require."}]}} | ba31497c70… | d8c690a570… |
| 39 | 11:10:35 AM | system | ASSESSMENT_AUTO_CLEARED | {"assessmentCode":"ASM-0008","level":2} | d8c690a570… | aea4c3af73… |
| 40 | 11:10:35 AM | connector.mes | RECORD_INGESTED | {"assessmentCode":"ASM-0009","systemCode":"MES","sourceRef":"MES-MFG-0288","requestedBy":"system","simulated":true} | aea4c3af73… | 49a5b13ebd… |
| 41 | 11:10:35 AM | ai.simulated | AI_ASSESSED | {"assessmentCode":"ASM-0009","factors":{"severity":3,"occurrence":3,"detection":2,"uncertainty":2,"importance":1,"complexity":1},"confidence":0.86,"recommendation":"review","rpn":18,"grade":"C3","level":3,"simulated":true} | 49a5b13ebd… | d9d080d909… |
| 42 | 11:10:35 AM | assurance | ASSURANCE_CHECKED | {"assessmentCode":"ASM-0009","report":{"rulesetVersion":"1.0.0","subject":"proposal","outcome":"passed","checkedOn":"2026-10-26","results":[{"ruleId":"P1","name":"Scores are on the defined scales","severity":"blocking","passed":true,"detail":"All six scores are whole numbers inside their scales."},{"ruleId":"P2","name":"Confidence is a real percentage","severity":"blocking","passed":true,"detail":"Confidence is 86%."},{"ruleId":"P3","name":"Recommendation is one the platform allows","severity":"blocking","passed":true,"detail":"The recommendation is “review”."},{"ruleId":"P4","name":"A reason is given","severity":"blocking","passed":true,"detail":"A reason is given."},{"ruleId":"P5","name":"It rests on documents that are in force today","severity":"blocking","passed":true,"detail":"All 2 named control(s) have a version in force."},{"ruleId":"P6","name":"Supporting text was found","severity":"warning","passed":true,"detail":"2 supporting passage(s) found."},{"ruleId":"P7","name":"Formality matches the risk","severity":"warning","passed":true,"detail":"Grade C3 is formal enough for the risk."},{"ruleId":"P8","name":"The AI did not try to lower the bar","severity":"warning","passed":true,"detail":"The AI’s recommendation does not try to go below what the fixed rules require."}]}} | d9d080d909… | d8fc895220… |
| 43 | 11:10:35 AM | system | ASSESSMENT_FLAGGED | {"assessmentCode":"ASM-0009","level":3,"reasons":["Risk level 3 (RPN 18) is at or above the QA threshold","The AI recommends a human review"]} | d8fc895220… | 7591ff8237… |
| 44 | 11:10:35 AM | connector.edms | RECORD_INGESTED | {"assessmentCode":"ASM-0010","systemCode":"EDMS","sourceRef":"VAL-IQ-0045","requestedBy":"system","simulated":true} | 7591ff8237… | 3e3bcd4cdd… |
| 45 | 11:10:35 AM | ai.simulated | AI_ASSESSED | {"assessmentCode":"ASM-0010","factors":{"severity":4,"occurrence":2,"detection":2,"uncertainty":2,"importance":1,"complexity":1},"confidence":0.79,"recommendation":"review","rpn":16,"grade":"C3","level":3,"simulated":true} | 3e3bcd4cdd… | ca7a2173cc… |
| 46 | 11:10:35 AM | assurance | ASSURANCE_CHECKED | {"assessmentCode":"ASM-0010","report":{"rulesetVersion":"1.0.0","subject":"proposal","outcome":"passed","checkedOn":"2026-10-26","results":[{"ruleId":"P1","name":"Scores are on the defined scales","severity":"blocking","passed":true,"detail":"All six scores are whole numbers inside their scales."},{"ruleId":"P2","name":"Confidence is a real percentage","severity":"blocking","passed":true,"detail":"Confidence is 79%."},{"ruleId":"P3","name":"Recommendation is one the platform allows","severity":"blocking","passed":true,"detail":"The recommendation is “review”."},{"ruleId":"P4","name":"A reason is given","severity":"blocking","passed":true,"detail":"A reason is given."},{"ruleId":"P5","name":"It rests on documents that are in force today","severity":"blocking","passed":true,"detail":"All 1 named control(s) have a version in force."},{"ruleId":"P6","name":"Supporting text was found","severity":"warning","passed":true,"detail":"2 supporting passage(s) found."},{"ruleId":"P7","name":"Formality matches the risk","severity":"warning","passed":true,"detail":"Grade C3 is formal enough for the risk."},{"ruleId":"P8","name":"The AI did not try to lower the bar","severity":"warning","passed":true,"detail":"The AI’s recommendation does not try to go below what the fixed rules require."}]}} | ca7a2173cc… | a86bfc5235… |
| 47 | 11:10:35 AM | system | ASSESSMENT_FLAGGED | {"assessmentCode":"ASM-0010","level":3,"reasons":["Risk level 3 (RPN 16) is at or above the QA threshold","The AI recommends a human review"]} | a86bfc5235… | 57a47d425b… |
| 48 | 11:10:36 AM | connector.lms | RECORD_INGESTED | {"assessmentCode":"ASM-0011","systemCode":"LMS","sourceRef":"TRN-0322","requestedBy":"system","simulated":true} | 57a47d425b… | a019965428… |
| 49 | 11:10:36 AM | ai.simulated | AI_ASSESSED | {"assessmentCode":"ASM-0011","factors":{"severity":3,"occurrence":1,"detection":2,"uncertainty":0,"importance":1,"complexity":0},"confidence":0.94,"recommendation":"clear","rpn":6,"grade":"A1","level":1,"simulated":true} | a019965428… | 685e0d3faa… |
| 50 | 11:10:36 AM | assurance | ASSURANCE_CHECKED | {"assessmentCode":"ASM-0011","report":{"rulesetVersion":"1.0.0","subject":"proposal","outcome":"passed","checkedOn":"2026-10-26","results":[{"ruleId":"P1","name":"Scores are on the defined scales","severity":"blocking","passed":true,"detail":"All six scores are whole numbers inside their scales."},{"ruleId":"P2","name":"Confidence is a real percentage","severity":"blocking","passed":true,"detail":"Confidence is 94%."},{"ruleId":"P3","name":"Recommendation is one the platform allows","severity":"blocking","passed":true,"detail":"The recommendation is “clear”."},{"ruleId":"P4","name":"A reason is given","severity":"blocking","passed":true,"detail":"A reason is given."},{"ruleId":"P5","name":"It rests on documents that are in force today","severity":"blocking","passed":true,"detail":"All 2 named control(s) have a version in force."},{"ruleId":"P6","name":"Supporting text was found","severity":"warning","passed":true,"detail":"2 supporting passage(s) found."},{"ruleId":"P7","name":"Formality matches the risk","severity":"warning","passed":true,"detail":"Grade A1 is formal enough for the risk."},{"ruleId":"P8","name":"The AI did not try to lower the bar","severity":"warning","passed":true,"detail":"The AI’s recommendation does not try to go below what the fixed rules require."}]}} | 685e0d3faa… | b019dd5963… |
| 51 | 11:10:36 AM | system | ASSESSMENT_AUTO_CLEARED | {"assessmentCode":"ASM-0011","level":1} | b019dd5963… | adfebf7e47… |
| 52 | 11:10:36 AM | connector.erp | RECORD_INGESTED | {"assessmentCode":"ASM-0012","systemCode":"ERP","sourceRef":"SO-55120","requestedBy":"system","simulated":true} | adfebf7e47… | 2bcecb69e4… |
| 53 | 11:10:36 AM | ai.simulated | AI_ASSESSED | {"assessmentCode":"ASM-0012","factors":{"severity":3,"occurrence":2,"detection":2,"uncertainty":1,"importance":1,"complexity":1},"confidence":0.7,"recommendation":"clear","rpn":12,"grade":"B2","level":3,"simulated":true} | 2bcecb69e4… | 03c9b38319… |
| 54 | 11:10:36 AM | assurance | ASSURANCE_CHECKED | {"assessmentCode":"ASM-0012","report":{"rulesetVersion":"1.0.0","subject":"proposal","outcome":"passed","checkedOn":"2026-10-26","results":[{"ruleId":"P1","name":"Scores are on the defined scales","severity":"blocking","passed":true,"detail":"All six scores are whole numbers inside their scales."},{"ruleId":"P2","name":"Confidence is a real percentage","severity":"blocking","passed":true,"detail":"Confidence is 70%."},{"ruleId":"P3","name":"Recommendation is one the platform allows","severity":"blocking","passed":true,"detail":"The recommendation is “clear”."},{"ruleId":"P4","name":"A reason is given","severity":"blocking","passed":true,"detail":"A reason is given."},{"ruleId":"P5","name":"It rests on documents that are in force today","severity":"blocking","passed":true,"detail":"All 1 named control(s) have a version in force."},{"ruleId":"P6","name":"Supporting text was found","severity":"warning","passed":true,"detail":"1 supporting passage(s) found."},{"ruleId":"P7","name":"Formality matches the risk","severity":"warning","passed":true,"detail":"Grade B2 is formal enough for the risk."},{"ruleId":"P8","name":"The AI did not try to lower the bar","severity":"warning","passed":true,"detail":"The AI’s recommendation does not try to go below what the fixed rules require."}]}} | 03c9b38319… | fb0d822d8f… |
| 55 | 11:10:36 AM | system | ASSESSMENT_FLAGGED | {"assessmentCode":"ASM-0012","level":3,"reasons":["AI confidence 70% is below the 75% needed to clear it alone"]} | fb0d822d8f… | f9f379bb93… |
| 56 | 12:33:48 PM | system | RISK_ASSESSMENT_SEEDED | {"code":"RA-AIV-0001","itemCount":8} | f9f379bb93… | 9e9fc48cab… |
| 57 | 12:55:04 PM | connector.eqms | RECORD_INGESTED | {"assessmentCode":"ASM-0013","systemCode":"EQMS","sourceRef":"CHG-2026-077","requestedBy":"auditor.demo","simulated":true} | 9e9fc48cab… | 3aa4de64ca… |
| 58 | 12:55:04 PM | ai.simulated | AI_ASSESSED | {"assessmentCode":"ASM-0013","factors":{"severity":2,"occurrence":1,"detection":1,"uncertainty":0,"importance":0,"complexity":0},"confidence":0.98,"recommendation":"clear","rpn":2,"grade":"A1","level":1,"simulated":true} | 3aa4de64ca… | 89c054b93d… |
| 59 | 12:55:04 PM | assurance | ASSURANCE_CHECKED | {"assessmentCode":"ASM-0013","report":{"rulesetVersion":"1.0.0","subject":"proposal","outcome":"passed","checkedOn":"2026-10-26","results":[{"ruleId":"P1","name":"Scores are on the defined scales","severity":"blocking","passed":true,"detail":"All six scores are whole numbers inside their scales."},{"ruleId":"P2","name":"Confidence is a real percentage","severity":"blocking","passed":true,"detail":"Confidence is 98%."},{"ruleId":"P3","name":"Recommendation is one the platform allows","severity":"blocking","passed":true,"detail":"The recommendation is “clear”."},{"ruleId":"P4","name":"A reason is given","severity":"blocking","passed":true,"detail":"A reason is given."},{"ruleId":"P5","name":"It rests on documents that are in force today","severity":"blocking","passed":true,"detail":"All 1 named control(s) have a version in force."},{"ruleId":"P6","name":"Supporting text was found","severity":"warning","passed":true,"detail":"2 supporting passage(s) found."},{"ruleId":"P7","name":"Formality matches the risk","severity":"warning","passed":true,"detail":"Grade A1 is formal enough for the risk."},{"ruleId":"P8","name":"The AI did not try to lower the bar","severity":"warning","passed":true,"detail":"The AI’s recommendation does not try to go below what the fixed rules require."}]}} | 89c054b93d… | 7f4d4b288e… |
| 60 | 12:55:04 PM | system | ASSESSMENT_AUTO_CLEARED | {"assessmentCode":"ASM-0013","level":1} | 7f4d4b288e… | cbd4f29b1f… |
| 61 | 12:55:10 PM | auditor.demo | CHAT_QUESTION | {"question":"What needs my review?"} | cbd4f29b1f… | 6fb3348a85… |
| 62 | 12:55:10 PM | assistant | CHAT_ANSWER | {"auditor":"auditor.demo","question":"What needs my review?","text":"5 items need your review, highest risk first:\n• ASM-0005 — Packaging line 2 label reconciliation variance (grade D4, RPN 24)\n• ASM-0009 — Batch record missing a second-person verification (grade C3, RPN 18)\n• ASM-0010 — Autoclave IQ executed with one calibration deviation (grade C3, RPN 16)\n• ASM-0001 — Temperature excursion in cold storage room 3 (grade C3, RPN 16)\n• ASM-0012 — Cold-chain shipping lane not yet qualified for summer (grade B2, RPN 12)\n\n1 more is waiting for the team to answer, so it isn't in your queue yet:\n• ASM-0006 — New excipient supplier introduced without qualification on file (asked Supplier Quality)","refs":["ASM-0005","ASM-0009","ASM-0010","ASM-0001","ASM-0012","ASM-0006"],"suggestions":["Tell me about ASM-0005","Why was ASM-0005 flagged?"],"engine":"simulated","assurance":{"rulesetVersion":"1.0.0","subject":"answer","outcome":"passed","checkedOn":"2026-10-26","results":[{"ruleId":"A1","name":"Every document it names is cited","severity":"blocking","passed":true,"detail":"No procedure is named."},{"ruleId":"A2","name":"Every version it cites is the one in force","severity":"blocking","passed":true,"detail":"No document version is relied on."},{"ruleId":"A3","name":"Quotations are word for word","severity":"blocking","passed":true,"detail":"Every quotation matches the cited text."},{"ruleId":"A4","name":"Records it mentions exist","severity":"blocking","passed":true,"detail":"6 record(s) mentioned, all exist."},{"ruleId":"A5","name":"No links to the outside","severity":"blocking","passed":true,"detail":"No web addresses."}]},"simulated":true} | 6fb3348a85… | a5cf4c533d… |
| 63 | 12:55:18 PM | connector.lims | RECORD_INGESTED | {"assessmentCode":"ASM-0014","systemCode":"LIMS","sourceRef":"ENV-26-0933","requestedBy":"auditor.demo","simulated":true} | a5cf4c533d… | 273c600f1d… |
| 64 | 12:55:19 PM | ai.simulated | AI_ASSESSED | {"assessmentCode":"ASM-0014","factors":{"severity":4,"occurrence":3,"detection":2,"uncertainty":2,"importance":2,"complexity":2},"confidence":0.83,"recommendation":"escalate","rpn":24,"grade":"D4","level":3,"simulated":true} | 273c600f1d… | 6d856ac4e4… |
| 65 | 12:55:19 PM | assurance | ASSURANCE_CHECKED | {"assessmentCode":"ASM-0014","report":{"rulesetVersion":"1.0.0","subject":"proposal","outcome":"passed","checkedOn":"2026-10-26","results":[{"ruleId":"P1","name":"Scores are on the defined scales","severity":"blocking","passed":true,"detail":"All six scores are whole numbers inside their scales."},{"ruleId":"P2","name":"Confidence is a real percentage","severity":"blocking","passed":true,"detail":"Confidence is 83%."},{"ruleId":"P3","name":"Recommendation is one the platform allows","severity":"blocking","passed":true,"detail":"The recommendation is “escalate”."},{"ruleId":"P4","name":"A reason is given","severity":"blocking","passed":true,"detail":"A reason is given."},{"ruleId":"P5","name":"It rests on documents that are in force today","severity":"blocking","passed":true,"detail":"All 2 named control(s) have a version in force."},{"ruleId":"P6","name":"Supporting text was found","severity":"warning","passed":true,"detail":"2 supporting passage(s) found."},{"ruleId":"P7","name":"Formality matches the risk","severity":"warning","passed":true,"detail":"Grade D4 is formal enough for the risk."},{"ruleId":"P8","name":"The AI did not try to lower the bar","severity":"warning","passed":true,"detail":"The AI’s recommendation does not try to go below what the fixed rules require."}]}} | 6d856ac4e4… | fb9684f799… |
| 66 | 12:55:19 PM | system | ASSESSMENT_FLAGGED | {"assessmentCode":"ASM-0014","level":3,"reasons":["Risk level 4 (RPN 24) is at or above the QA threshold","The AI recommends escalation"]} | fb9684f799… | 08dca67f35… |
| 67 | 12:55:44 PM | auditor.demo | CHAT_QUESTION | {"question":"Why was ASM-0005 flagged?"} | 08dca67f35… | 189130958e… |
| 68 | 12:55:44 PM | assistant | CHAT_ANSWER | {"auditor":"auditor.demo","question":"Why was ASM-0005 flagged?","text":"ASM-0005 needs a human because:\n• Risk level 4 (RPN 24) is at or above the QA threshold\n• The AI recommends escalation\n\nThe AI's own reasoning: Unaccounted labels risk a mix-up reaching the patient. Zero-tolerance limit was breached, so this should not be closed without a human decision.\n\nWhat the controlled documents say:\n• SOP-PKG-005 v5.0 §5.1, Zero-tolerance reconciliation: \"Printed labels issued to a line must be reconciled exactly against labels used, rejected and returned.\"\n• SOP-PKG-005 v5.0 §5.3, Mix-up risk: \"Unaccounted labels are treated as a potential mix-up that could reach the patient, and the batch is quarantined until the reconciliation is explained.\"","citations":[{"docId":"SOP-PKG-005","docTitle":"Labelling Reconciliation","version":"5.0","sectionId":"5.1","heading":"Zero-tolerance reconciliation","excerpt":"Printed labels issued to a line must be reconciled exactly against labels used, rejected and returned. The limit for unaccounted labels is zero. Any variance stops the line and starts a deviation before the batch can proceed."},{"docId":"SOP-PKG-005","docTitle":"Labelling Reconciliation","version":"5.0","sectionId":"5.3","heading":"Mix-up risk","excerpt":"Unaccounted labels are treated as a potential mix-up that could reach the patient, and the batch is quarantined until the reconciliation is explained."}],"refs":["ASM-0005"],"suggestions":["What should I do about ASM-0005?","What else needs my review?","Give me an overview"],"engine":"simulated","assurance":{"rulesetVersion":"1.0.0","subject":"answer","outcome":"passed","checkedOn":"2026-10-26","results":[{"ruleId":"A1","name":"Every document it names is cited","severity":"blocking","passed":true,"detail":"SOP-PKG-005 named and cited."},{"ruleId":"A2","name":"Every version it cites is the one in force","severity":"blocking","passed":true,"detail":"SOP-PKG-005 v5.0 in force."},{"ruleId":"A3","name":"Quotations are word for word","severity":"blocking","passed":true,"detail":"Every quotation matches the cited text."},{"ruleId":"A4","name":"Records it mentions exist","severity":"blocking","passed":true,"detail":"1 record(s) mentioned, all exist."},{"ruleId":"A5","name":"No links to the outside","severity":"blocking","passed":true,"detail":"No web addresses."}]},"simulated":true} | 189130958e… | fc6baee1d8… |