{ "created_at": "2026-11-12T07:59:12Z", "result": { "engine": "regulated_evidence", "limits": "Reviews the pack record. It does not audit the trial, certify compliance, or prove the control evidence is truthful. The run is Ed25519-signed; pin the issuer key out of band.", "module": "cain_a75_engines/regulatedevidence/engine.py", "profile": "gxp_oversight_pack", "run": { "label": "Recomputes a regulated evidence pack: signed records, approvals, control/evidence status, deviation CAPAs, retention and claim honesty. It does not audit the trial or certify compliance.", "public_key_b64": "zTXFfoDyWVoCfbZmw9tSQarmK/kn1FepsQb/sOttbzA=", "records": [ { "checks": [ { "detail": "workflow id and version", "id": "workflow.named", "ok": true }, { "detail": "an actor is named", "id": "S-enroll.actor", "ok": true }, { "detail": "a control is named", "id": "S-enroll.control", "ok": true }, { "detail": "every record is hashed, signed and timestamped", "id": "S-enroll.records", "ok": true }, { "detail": "an actor is named", "id": "S-dose.actor", "ok": true }, { "detail": "a control is named", "id": "S-dose.control", "ok": true }, { "detail": "every record is hashed, signed and timestamped", "id": "S-dose.records", "ok": true }, { "detail": "approved by 'human:pi'", "id": "S-dose.approval", "ok": true }, { "detail": "approval timestamp", "id": "S-dose.approval_time", "ok": true }, { "detail": "an actor is named", "id": "S-report.actor", "ok": true }, { "detail": "a control is named", "id": "S-report.control", "ok": true }, { "detail": "every record is hashed, signed and timestamped", "id": "S-report.records", "ok": true }, { "detail": "status 'met'", "id": "control.C1.status", "ok": true }, { "detail": "evidence ['R-1']", "id": "control.C1.evidence", "ok": true }, { "detail": "status 'met'", "id": "control.C2.status", "ok": true }, { "detail": "evidence ['R-2']", "id": "control.C2.evidence", "ok": true }, { "detail": "status 'na'", "id": "control.C3.status", "ok": true }, { "detail": "no control gap", "id": "control.C3.not_gap", "ok": true }, { "detail": "CAPA 'CAPA-1' addresses the deviation", "id": "deviation.D1.capa", "ok": true }, { "detail": "CAPA status 'closed'", "id": "deviation.D1.closed", "ok": true }, { "detail": "10.0 >= 10 years for GxP", "id": "retention.years", "ok": true }, { "detail": "immutable storage", "id": "retention.immutable", "ok": true }, { "detail": "backup exists", "id": "retention.backup", "ok": true }, { "detail": "claimed True, computed True", "id": "claims.all_controls_met", "ok": true }, { "detail": "claimed True, computed True", "id": "claims.all_deviations_capa", "ok": true }, { "detail": "claimed True, computed True", "id": "claims.retention_sufficient", "ok": true } ], "created_at": "2026-11-12T07:59:12Z", "engine": "a75-034/1.0.0", "extra": { "computed": { "all_controls_met": true, "all_deviations_capa": true, "retention_sufficient": true }, "deviations": { "D1": { "capa": "CAPA-1", "severity": "medium" } }, "steps": { "S-dose": { "actor": "agent:dose", "requires_approval": true }, "S-enroll": { "actor": "agent:coordinator", "requires_approval": false }, "S-report": { "actor": "agent:reporter", "requires_approval": false } } }, "failed": [], "label": "Recomputes a regulated evidence pack: signed records, approvals, control/evidence status, deviation CAPAs, retention and claim honesty. It does not audit the trial or certify compliance.", "prev_record_hash": "cb2cf201f23b79d8b0198121e5bde79d0226c533c391641604a853897f35c81d", "public_key_b64": "zTXFfoDyWVoCfbZmw9tSQarmK/kn1FepsQb/sOttbzA=", "record_hash": "3855c105c8d07d2e1a40889725e906a78afbd80812fc9137c64cdf4b3214d315", "schema": "cain42.a75.regulated.record.v1", "signature_b64": "gUdRr79cUCaPJ72lhl0EgYS3jZ9PiG/hR4xePaeeGNKvTkqA2gt4HzujP58NP/mDF7ZA4wJc91RzKc1G5E6zAg==", "sku": "CAIN-A75-034", "subject": { "capa": [ { "addresses": [ "D1" ], "evidence_sha256": "bbbbbbbbbbbbbbbbbbbbbbbbbbbbbbbbbbbbbbbbbbbbbbbbbbbbbbbbbbbbbbbb", "id": "CAPA-1", "status": "closed" } ], "claims": { "all_controls_met": true, "all_deviations_capa": true, "retention_sufficient": true }, "controls": [ { "evidence_ids": [ "R-1" ], "id": "C1", "status": "met" }, { "evidence_ids": [ "R-2" ], "id": "C2", "status": "met" }, { "id": "C3", "status": "na" } ], "deviations": [ { "capa_id": "CAPA-1", "id": "D1", "severity": "medium", "step": "S-dose" } ], "retention": { "backup": true, "immutable": true, "years": 10.0 }, "schema": "cain42.a75.regulated.pack.v1", "steps": [ { "actor": "agent:coordinator", "control": "informed-consent", "id": "S-enroll", "records": [ { "id": "R-1", "sha256": "aaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaa", "signed": true, "timestamp": "2026-11-01T10:00:00Z" } ], "requires_approval": false }, { "actor": "agent:dose", "approval": { "at": "2026-11-01T10:05:00Z", "by": "human:pi" }, "control": "dose-check", "id": "S-dose", "records": [ { "id": "R-2", "sha256": "aaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaa", "signed": true, "timestamp": "2026-11-01T10:00:00Z" } ], "requires_approval": true }, { "actor": "agent:reporter", "control": "safety-report", "id": "S-report", "records": [ { "id": "R-3", "sha256": "aaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaa", "signed": true, "timestamp": "2026-11-01T10:00:00Z" } ], "requires_approval": false } ], "workflow": { "id": "ct-oversight", "regulation": "GxP", "version": "1.0" } }, "subject_sha256": "cd56f0c3e03befd52a015f9fe08c20c3f4e917c37c38095cf541283e4cbbc53f", "verdict": "COMPLIANT" } ], "run_hash": "b77e33092a2b3bd3bd6431e6833887a7bcb88f02de6cd3cdb99801fe4ec020b8", "schema": "cain42.a75.regulated.run.v1", "sku": "CAIN-A75-034", "verdict": "VERIFIED", "verdicts": [ "COMPLIANT" ] }, "scenarios": [ { "name": "gxp_oversight_pack", "run_hash": "b77e33092a2b3bd3bd6431e6833887a7bcb88f02de6cd3cdb99801fe4ec020b8", "steps": 3, "verdict": "VERIFIED" }, { "expected": "COMPLIANT", "name": "honest_regulated_pack", "verdict": "COMPLIANT" }, { "expected": "NON_COMPLIANT", "name": "unsigned_record", "verdict": "NON_COMPLIANT" }, { "expected": "NON_COMPLIANT", "name": "missing_record_hash", "verdict": "NON_COMPLIANT" }, { "expected": "NON_COMPLIANT", "name": "critical_step_without_approval", "verdict": "NON_COMPLIANT" }, { "expected": "NON_COMPLIANT", "name": "self_approved_critical_step", "verdict": "NON_COMPLIANT" }, { "expected": "NON_COMPLIANT", "name": "control_gap", "verdict": "NON_COMPLIANT" }, { "expected": "NON_COMPLIANT", "name": "control_evidence_missing", "verdict": "NON_COMPLIANT" }, { "expected": "NON_COMPLIANT", "name": "deviation_without_capa", "verdict": "NON_COMPLIANT" }, { "expected": "NON_COMPLIANT", "name": "open_capa", "verdict": "NON_COMPLIANT" }, { "expected": "NON_COMPLIANT", "name": "high_severity_open", "verdict": "NON_COMPLIANT" }, { "expected": "NON_COMPLIANT", "name": "retention_too_short", "verdict": "NON_COMPLIANT" }, { "expected": "NON_COMPLIANT", "name": "not_immutable", "verdict": "NON_COMPLIANT" }, { "expected": "NON_COMPLIANT", "name": "no_backup", "verdict": "NON_COMPLIANT" }, { "expected": "NON_COMPLIANT", "name": "duplicate_step", "verdict": "NON_COMPLIANT" }, { "expected": "NON_COMPLIANT", "name": "claim_overstates", "verdict": "NON_COMPLIANT" }, { "expected": "NON_COMPLIANT", "name": "unknown_claim", "verdict": "NON_COMPLIANT" }, { "expected": "NON_COMPLIANT", "name": "wrong_schema", "verdict": "NON_COMPLIANT" }, { "expected": "NON_COMPLIANT", "name": "garbage", "verdict": "NON_COMPLIANT" } ], "summary": "VERIFIED: signed records, approvals, controls, CAPAs and retention recomputed; 18/18 pack-failure cases as expected" }, "schema": "cain42.agentic75.findings.v1", "sku": "CAIN-A75-034" }