Sentinel QMS v4 – Human‑Executed Reproducibility Audit (RUN015) for AuditLog.AI v4.0: Zero‑Custody, Bitcoin‑Anchored Evidence Dossier (Ordinal 13)

Sentinel QMS v4 — Human-Executed Reproducibility Audit (RUN015) AuditLog.AI • Zero-Custody • OP_RETURN-Anchored © 2025 Cardiovascular Diagnostic Audit & AI Pty — Sentinel Protocol v4 QMS UTC (Audit Date): 2025-11-04 AuditLog.AI v4 Final Reproducibility Validation (REGULATORY-RUN15) Sentinel Protocol QMS v4 Cryptographically Anchored Audit – Zero-Custody & Human-Verified Execution Regulatory Submission Software: AuditLog.AI Date: November 15, 2025 Inventor and Primary Contact Dr. Fernando Telles, BMedSc(Adv), MD(Dist)¹ ² Position: CEO & Founder Email: [email protected] Phone: Provided on Request Address: 21 Shields St, Flemington VIC 3031, AU Web: www.aihumansynergy.org Engineers Lead Software Engineer: Dr. Jacob Yang BEng, MEng, PhD¹ Software Engineer: Benjamin Hookey BEng (Mechatronics & Robotics), FSEng (Safety Instrumented Systems)¹ Affiliations ¹ Cardiovascular Diagnostic Audit & AI Pty Ltd (ACN 638 019 431) – Registered Australian company conducting AuditLog.AI software development, audit and research services ² Telles Investments Pty Ltd (ACN 638 017 384) – Private IP holder IP Rights US Provisional #63/826,381 · AU Provisional #2025902482 · AU Trade Mark #2535745 & #2549093 IP Priority Date: 17 June 2025 (Global) Submitted as part of the AuditLog.AI Global Regulatory Submission Package (FDA/EMA/TGA/PCAOB/ISA Alignment) Page 1 of 69 HV_FT0001AUDITLOGAI_RUN15 Sentinel QMS v4 — Human-Executed Reproducibility Audit (RUN015) AuditLog.AI • Zero-Custody • OP_RETURN-Anchored © 2025 Cardiovascular Diagnostic Audit & AI Pty — Sentinel Protocol v4 QMS UTC (Audit Date): 2025-11-04 Regulatory Summary — AuditLog.AI Reproducibility Audit (RUN015) Sentinel Protocol QMS v4 • Zero-Custody • Human-Verified • Bitcoin-Anchored This summary provides a concise, regulator-facing overview of the reproducibility findings for AuditLog.AI v4.0, executed under Sentinel QMS v4 on 04 November 2025. All verification steps were performed by the human operator only, using independent open-source tools. Reproducibility Outcomes (Executive Summary) • All canonical evidence — MATCH (SHA-256 / RIPEMD-160 parity confirmed across all canonical artifacts) • All positive controls — MATCH (Frozen copies, public repositories, DOI mirrors, and independent sources) • All negative controls — MISMATCH (expected) (Metadata-only changes and minimal content alterations correctly detected) • 100% reproducibility across all evidence classes (Canonicals, PCs, NCs, regulatory references, and session logs) • 0 discrepancies across all 69 pages of evidence (No deviations, no unexplained hash differences, no validation failures) • Bitcoin OP_RETURN anchoring verified (Payload parity: SENTINEL|SESSION|9820d4fea8db0fd96e576cabc3c3ac1f2f1bcb62|6936c54c; TXID: d2746ef7…; Block 922142) • Human-only execution (validated) (Independent screen recording, PRE/POST screenshots, and audit log meta-layer) • No AI involvement in the audit execution sequence (AI was not used for the reproducibility run; all verification steps—dual-hash computation, canonical/parity checks, positive and negative control validation, and Bitcoin payload verification—were executed by the human operator only. Sentinel QMS v4 modules were used strictly for audit planning, post-execution documentation structuring, and independent machineaudit verification of frozen human-execution evidence. No AI produced or influenced any audit results.) Regulatory Relevance This audit satisfies reproducibility, traceability, and evidentiary sufficiency requirements under: • FDA 21 CFR Part 11 • EMA Annex 11 + GCP (2023) • TGA / PIC/S PE009-17 • PCAOB AS 1215 / AS 1105 • ISA 230 / ISA 500 / ISA 240 (Revised 2025) The results confirm that AuditLog.AI maintains immutable audit trails, deterministic dual-hash parity, and public-ledger-verifiable proof-of-execution, fulfilling all reproducibility expectations for global regulatory submissions. Page 2 of 69 HV_FT0002AUDITLOGAI_RUN15 Sentinel QMS v4 — Human-Executed Reproducibility Audit (RUN015) AuditLog.AI • Zero-Custody • OP_RETURN-Anchored © 2025 Cardiovascular Diagnostic Audit & AI Pty — Sentinel Protocol v4 QMS UTC (Audit Date): 2025-11-04 AuditLog.AI v4 Final Reproducibility Validation (REGULATORY-RUN15) Sentinel Protocol QMS v4 Cryptographically Anchored Audit – ZeroCustody & Human-Verified Execution Audit Date: 04 November 2025 Auditor: Dr. Fernando Telles BMedSc (Adv), MD (Dist) System Context Overview Segment Component Meaning AuditLog.AI Software Primary audit target; commercial product under validation Sentinel QMS (v4) Protocol integrity layer Quality Management System v4 governing validation, release, and audit controls System type AI-Human Synergy™ Cooperative execution architecture embedding Ethics Firewall (C5.2) and human-verified governance Mode Zero-custody & human-verified Ensures no raw data transfer; all operations require human approval and cryptographic attestation Checksum pair SHA-256 / RIPEMD-160 (dual-verified) Two-stage digest pair providing deterministic reproducibility and tamper evidence Blockchain anchor Bitcoin mainnet (OP_RETURN) Immutable public anchoring of proof-only payloads for timestamp and integrity UTC timestamp layer VALIS filename standard (___<UTC>.ext) Deterministic, human-readable UTC attestation applied during hashing to every frozen artifact Decentralized time-attestation OpenTimestamps (OTS) Independent, decentralized time-stamping protocol confirming file existence at a specified Bitcoin Block Custodian CDA AI Pty Ltd (ACN 638 019 431) Regulatory audit operator and anchor-infrastructure maintainer under Sentinel Protocol v4 QMS Outcome Summary Audit Target Version Description Audit Type Result Meaning AuditLog.AI v4.0 Standalone audit trail software (non-device) Reproducibility Validation PASS 100% SHA-256 / RIPEMD-160 parity verified All results verified under Sentinel Protocol QMS v4, dual-ledger cross-check and Bitcoin anchor confirmed. • Dual-hash SHA256 & RIPEMD160 match on all CANONICAL files • Dual-hash SHA256 & RIPEMD160 match on all POSITIVE CONTROL files • Dual-hash SHA256 & RIPEMD160 mismatch on all NEGATIVE CONTROL files • Dual-hash SHA256 & RIPEMD160 mismatch on all Fraud Detection Testing (metadata) NEGATIVE CONTROL files • Payload match on all session logs dual-hash re-execution (|ripemd160|sha8) against bitcoin mainnet TXID • Payload match on Ordinal 11 and Ordinal 12 open-science publications (|ripemd160|sha8) against bitcoin mainnet TXID All reproducibility checkpoints passed; no discrepancies detected in canonical or positive controls. All negative controls correctly failed integrity validation. Page 3 of 69 HV_FT0003AUDITLOGAI_RUN15 Sentinel QMS v4 — Human-Executed Reproducibility Audit (RUN015) AuditLog.AI • Zero-Custody • OP_RETURN-Anchored © 2025 Cardiovascular Diagnostic Audit & AI Pty — Sentinel Protocol v4 QMS UTC (Audit Date): 2025-11-04 Audit Identifiers Item Reference Final Audit File (Ordinal 13 – Canonical Submission) SentinelQMSv4_AUDIT_REPRODUCIBILITY_<PASS/FAIL>_AuditLog.AI_sha25 6_6936c54c_ripemd160_9820d4fe_TXID_d2746ef7_BTC922142___<UTC>.pdf Human Audit File (Pre-Audit evidence – byte-identical) SentinelQMSv4_PRE_AUDIT_EVIDENCE_AuditLog.AI_sha256_6936c54c_ripe md160_9820d4fe_TXID_d2746ef7_BTC922142___<UTC>.pdf Report Markdown Source AUDIT_REPRODUCIBILITY_PASS_AuditLog.AI_sha256_ripemd160_payload_T XID_v.04Nov.25___20251104T063220Z.md Audit Plan (Appendix A) AuditPlan_v.04Nov.25___20251104T063215Z.md Session ID (Meta ID) AuditLogAI.REG.GlobalSubmission.v4071 (REGULATORY-RUN15) Transaction ID (TXID) d2746ef74e5d678861b06018394af473ead923ce2ee589d527c2204cce8dc708 Payload (OP_RETURN) SENTINEL|SESSION|9820d4fea8db0fd96e576cabc3c3ac1f2f1bcb62|6936c54c Verification Summary Human-only re-execution using independent open-source tools (dualhasher_public_sentinel_v1.1.py, extract_hashes.py), validated against Bitcoin mainnet ledger. Live full-screen recording captured all stages of hash regeneration, parity confirmation, and payload verification. Results confirm complete reproducibility of all canonical files. Note: Hash computations are content-based. • File-name changes do not alter the SHA-256 / RIPEMD-160 values, which are derived solely from the file’s binary contents. • Accordingly, identical content under different titles will always yield the same dual-hash pair. Context This audit verifies that every evidence artifact and prior regulatory reference (Ordinals 11 & 12) remains hash-parity identical to its original anchored state. Upon successful anchoring of this audit (REGULATORY-RUN015) and subsequent governance demonstrations (RUN016 - RUN017), the AuditLog.AI Global Regulatory Submission Package is confirmed reproducible, traceable, and closed under immutable cryptographic proof. Audit Plan, Appendix A Appendix A is the original Audit Plan (v. 04 Nov 25), preserved in full and converted to PDF without any modification to its substantive content. This plan was prepared prior to execution of REGULATORY-RUN15 and defines the audit’s scope, method, and validation criteria. Inclusion of the plan preserves the pre-execution intent and aligns with evidentiary completeness requirements under Sentinel Protocol v4 QMS. Page 4 of 69 HV_FT0004AUDITLOGAI_RUN15 Sentinel QMS v4 — Human-Executed Reproducibility Audit (RUN015) AuditLog.AI • Zero-Custody • OP_RETURN-Anchored © 2025 Cardiovascular Diagnostic Audit & AI Pty — Sentinel Protocol v4 QMS UTC (Audit Date): 2025-11-04 Audit Execution Methods Execution Evidence Verification with Independent Tools (dualhasher_public_sentinel_v1.1.py and extract_hashes.py) Evidence File 1of 3: ts_00_51_37_dualhasher_public_sentinel_v1.1.py_execution_Session_Logs___20251104T2311 50Z.png Description: CLI run of dualhasher (independent tool) over session logs. Observation: Start-to-finish terminal output shows .hash/.2ha creation. Outcome: Method execution evidence – PASS (procedure recorded). Page 5 of 69 HV_FT0005AUDITLOGAI_RUN15 Sentinel QMS v4 — Human-Executed Reproducibility Audit (RUN015) AuditLog.AI • Zero-Custody • OP_RETURN-Anchored © 2025 Cardiovascular Diagnostic Audit & AI Pty — Sentinel Protocol v4 QMS UTC (Audit Date): 2025-11-04 Evidence File 2 of 3: ts_00_52_30_extract_hashes.py_execution_Session_Logs___20251104T231150Z.png Description: CLI run of extract_hashes over session logs. Observation: Summary table with SHA-256 and RIPEMD-160 columns exported. Outcome: Method execution evidence – PASS (manifest generated). Evidence File 3 of 3: ts_00_53_00_extract_hashes.py_execution_cont_Session_Logs___20251104T231150Z.png Description: Continuation of extract_hashes run. Observation: Additional files listed; export path visible. Outcome: Method execution evidence – PASS (complete listing). Page 6 of 69 HV_FT0006AUDITLOGAI_RUN15 Sentinel QMS v4 — Human-Executed Reproducibility Audit (RUN015) AuditLog.AI • Zero-Custody • OP_RETURN-Anchored © 2025 Cardiovascular Diagnostic Audit & AI Pty — Sentinel Protocol v4 QMS UTC (Audit Date): 2025-11-04 Audit Target Files (Canonical) Audit Target File A1 Primary (Ordinal 11) AuditLog.AI_Runtime_Execution_and_System_Validation_Evidence_Dossier_FINAL_METADAT A___20251027T231047Z.pdf Immutable Anchor: ORDINAL11|b0c8b2223eab705cac6bf7801b64945f7ed47022|fc46851b SHA-256: fc46851b4854ca45798b741c0fb001eaa0945eb73c98795900c87939acb30d8a RIPEMD-160: b0c8b2223eab705cac6bf7801b64945f7ed47022 OP_Return TXID: a09523a5e311d5e5213cba7cc39ec3a274aa1cc017be369cfa5786c3677a1540 Ordinal TXID: 6754818e57d5dcc16a7fccdb1d36bb213cd39ae4a180e17923387738f38a3f41 Evidence File 1 of 2: ts_01_17_15_ORDINAL11_blockchain.com___20251104T231150Z.png Description: Public explorer view of OP_RETURN transaction for Ordinal 11. Observation: TXID and payload visible; block height shown. Outcome: Integrity validation – PASS (payload matches audit digest). Page 7 of 69 HV_FT0007AUDITLOGAI_RUN15 Sentinel QMS v4 — Human-Executed Reproducibility Audit (RUN015) AuditLog.AI • Zero-Custody • OP_RETURN-Anchored © 2025 Cardiovascular Diagnostic Audit & AI Pty — Sentinel Protocol v4 QMS UTC (Audit Date): 2025-11-04 Evidence File 2 of 2: ts_01_17_34_ORDINAL11_ordinals.com___20251104T231150Z.png Description: Public explorer ordinals.com inscription view for Ordinal 11. Observation: Inscription transaction confirms immutable anchor state. Outcome: Anchor confirmation – PASS (independent site). Manifest Reference: SHA-256 and RIPEMD-160 values for Audit Target File A1 Primary (Ordinal 11) are registered in manifest_Submission_file_dossier_REGULATORY-RUN-20251027-S01.csv, included within the frozen REGULATORY-RUN15 evidence archive. Page 8 of 69 HV_FT0008AUDITLOGAI_RUN15 Sentinel QMS v4 — Human-Executed Reproducibility Audit (RUN015) AuditLog.AI • Zero-Custody • OP_RETURN-Anchored © 2025 Cardiovascular Diagnostic Audit & AI Pty — Sentinel Protocol v4 QMS UTC (Audit Date): 2025-11-04 Audit Target File A2 Primary (Ordinal 12) C12_AuditLog.AI_Globally_Harmonized_Cryptographically_Anchored_Compliance_Map_for_Dig ital_Audit_and_Reproducibility_Systems_FINAL_METADATA___20251028T043727Z.pdf Immutable Anchor: ORDINAL12|fb1822a8113a1b691a7ef64bb7cd64ea2fa02bc8|bbedad71 SHA-256: bbedad71af2064fb2456c73483984c538c66c2ed344f2a1cf34eef23cab14b81 RIPEMD-160: fb1822a8113a1b691a7ef64bb7cd64ea2fa02bc8 OP_Return TXID: e3dd84f739d2daf3f60177ce93e44648e9c57ef596090ef9a0474e0fc4fae326 Ordinal TXID: 7917e0f12fcff508d387733fd543451846316a21b16ca3f0d872b9849f94a904 Evidence File 1 of 2: ts_01_17_51_ORDINAL12_blockchain.com___20251104T231150Z.png Description: Public explorer view of OP_RETURN transaction for Ordinal 12. Observation: Transaction details and OP_RETURN payload visible. Outcome: Integrity validation – PASS (payload parity). Page 9 of 69 HV_FT0009AUDITLOGAI_RUN15 Sentinel QMS v4 — Human-Executed Reproducibility Audit (RUN015) AuditLog.AI • Zero-Custody • OP_RETURN-Anchored © 2025 Cardiovascular Diagnostic Audit & AI Pty — Sentinel Protocol v4 QMS UTC (Audit Date): 2025-11-04 Session Log File: session_log_AuditLogAI.REG.GlobalSubmission.v4051_20251026T085338.849295Z.json REGULATORY-RUN ID: 011 Meta ID: AuditLogAI.REG.GlobalSubmission.v4051 UTC: 20251026T085338.849295Z SHA-256: 05a3e17dfc281b22d82edd943f2c00d8c928e585c17f8490b2894f52469ba629 RIPEMD-160: e27980be020be1a3aa2533e0b15496d829fb7565 Independent time attestation - OpenTimestamps.org: OTS Proof: session_log_AuditLogAI.REG.GlobalSubmission.v4051_20251026T085338.849295Z.hash.ots OTS SHA-256: 354d71bcc4526863d2d8b83ba467ebd87012760b07daad72977e70f06f6da77a Non_Evidence_Screenshot 2025-11-09 at 8.42.10 am AMPLIFY LEDGER excerpt: {"ts": "2025-10-26T09:10:53Z", "event": "ANCHORED_RECEIPT_WRITTEN", "source": "confirm_watcher_queue", "chain": "btc", "txid": "a2911413665c354be96c68ad2fde7c5faebf36e3c060e624e2ab4acb2886bbe0", "height": 920854, "confirmations": 1, "session_meta_id": "AuditLogAI.REG.GlobalSubmission.v4051", "payload": "SENTINEL|SESSION|e27980be020be1a3aa2533e0b15496d829fb7565|05a3e17d", "receipt": "receipt_anchored_AuditLogAI.REG.GlobalSubmission.v4051_a2911413665c354be96c68ad2fde7c5faebf3 6e3c060e624e2ab4acb2886bbe0_920854.json", "tier": "CRO", "unit_price_usd": 150, "source_job": "incoming_anchor_AuditLogAI.REG.GlobalSubmission.v4051_20251026T085602.633483Z.json"} Evidence File: ts_01_19_23_session_log_AuditLogAI.REG.GlobalSubmission.v4051_blockchain.com___20251 104T231150Z.png Page 16 of 69 HV_FT0016AUDITLOGAI_RUN15 Sentinel QMS v4 — Human-Executed Reproducibility Audit (RUN015) AuditLog.AI • Zero-Custody • OP_RETURN-Anchored © 2025 Cardiovascular Diagnostic Audit & AI Pty — Sentinel Protocol v4 QMS UTC (Audit Date): 2025-11-04 Session Log File: session_log_AuditLogAI.REG.GlobalSubmission.v4042_20251020T194225.497227Z.json REGULATORY-RUN ID: 010 Meta ID: AuditLogAI.REG.GlobalSubmission.v4042 UTC: 20251020T194225.497227Z SHA-256: 5c6899adad23ba9e5cbe2c1e57b2a11df3ac4d29f0fa2b27a9dc52b3993d859a RIPEMD-160: 62906b9bc17efa60726d54455bbb00252384e01e Independent time attestation - OpenTimestamps.org: OTS Proof: session_log_AuditLogAI.REG.GlobalSubmission.v4042_20251020T194225.497227Z.hash.ots OTS SHA-256: c14cb699a75ed860fda27012629c3862d720ed54b8518f5c53dc689fa006e455 Non_Evidence_Screenshot 2025-11-09 at 8.45.11 am AMPLIFY LEDGER excerpt: {"ts": "2025-10-20T19:48:13Z", "event": "ANCHORED_RECEIPT_WRITTEN", "source": "confirm_watcher_queue", "chain": "btc", "txid": "2d09fbf521d651f95801662cb916ace6edf9586d3405dc6521edffe2d462800f", "height": 919987, "confirmations": 1, "session_meta_id": "AuditLogAI.REG.GlobalSubmission.v4042", "payload": "SENTINEL|SESSION|62906b9bc17efa60726d54455bbb00252384e01e|5c6899ad", "receipt": "receipt_anchored_AuditLogAI.REG.GlobalSubmission.v4042_2d09fbf521d651f95801662cb916ace6edf95 86d3405dc6521edffe2d462800f_919987.json", "tier": "CRO", "unit_price_usd": 150, "source_job": "incoming_anchor_AuditLogAI.REG.GlobalSubmission.v4042_20251020T194617.442312Z.json"} Evidence File: ts_01_19_36_session_log_AuditLogAI.REG.GlobalSubmission.v4042_blockchain.com___20251 104T231150Z.png Page 17 of 69 HV_FT0017AUDITLOGAI_RUN15 Sentinel QMS v4 — Human-Executed Reproducibility Audit (RUN015) AuditLog.AI • Zero-Custody • OP_RETURN-Anchored © 2025 Cardiovascular Diagnostic Audit & AI Pty — Sentinel Protocol v4 QMS UTC (Audit Date): 2025-11-04 Session Log File: session_log_AuditLogAI.REG.GlobalSubmission.v4038_20251018T214519.997259Z.json REGULATORY-RUN ID: 009 Meta ID: AuditLogAI.REG.GlobalSubmission.v4038 UTC: 20251018T214519.997259Z SHA-256: 5af54564b05e7ae9c8e6b4c918ca19586ca3c7e58af6b72806fa08603b27e844 RIPEMD-160: fb5e9fa9e3873fe2236eaf1c60c4fc7dd0968c5a Independent time attestation - OpenTimestamps.org: OTS Proof: session_log_AuditLogAI.REG.GlobalSubmission.v4038_20251018T214519.997259Z.hash.ots OTS SHA-256: 40f3a9bf146ba3294bf682eeb260bfbe7eb3813c9f313660fcda89499c518b33 Non_Evidence_Screenshot 2025-11-09 at 8.47.11 am AMPLIFY LEDGER excerpt: {"ts": "2025-10-18T22:13:43Z", "event": "ANCHORED_RECEIPT_WRITTEN", "source": "confirm_watcher_queue", "chain": "btc", "txid": "11fb255046a7934e5c978b3d0887318f85af3324b040873ce6026fea6c8af13d", "height": 919720, "confirmations": 1, "session_meta_id": "AuditLogAI.REG.GlobalSubmission.v4038", "payload": "SENTINEL|SESSION|fb5e9fa9e3873fe2236eaf1c60c4fc7dd0968c5a|5af54564", "receipt": "receipt_anchored_AuditLogAI.REG.GlobalSubmission.v4038_11fb255046a7934e5c978b3d0887318f85af3 324b040873ce6026fea6c8af13d_919720.json", "tier": "CRO", "unit_price_usd": 150, "source_job": "incoming_anchor_AuditLogAI.REG.GlobalSubmission.v4038_20251018T220557.638396Z.json"} Evidence File: ts_01_19_48_session_log_AuditLogAI.REG.GlobalSubmission.v4038_blockchain.com___20251 104T231150Z.png Page 18 of 69 HV_FT0018AUDITLOGAI_RUN15 Sentinel QMS v4 — Human-Executed Reproducibility Audit (RUN015) AuditLog.AI • Zero-Custody • OP_RETURN-Anchored © 2025 Cardiovascular Diagnostic Audit & AI Pty — Sentinel Protocol v4 QMS UTC (Audit Date): 2025-11-04 Session Log File: session_log_AuditLogAI.REG.GlobalSubmission.v4034_20251018T001855.666955Z.json REGULATORY-RUN ID: 008 Meta ID: AuditLogAI.REG.GlobalSubmission.v4034 UTC: 20251018T001855.666955Z SHA-256: ef6556d6a4b9d035a5f100560ab3ce17f10024551e3c0955f42b1f871496eae4 RIPEMD-160: 6fc7fef1cb6734cd5a3bb1147c25b756e9a41669 Independent time attestation - OpenTimestamps.org: OTS Proof: session_log_AuditLogAI.REG.GlobalSubmission.v4034_20251018T001855.666955Z.hash.ots OTS SHA-256: ced3a64a8d68445def3de91e0b9f2e94e9472934308c30c83cc7f861729079ab Non_Evidence_Screenshot 2025-11-09 at 8.49.26 am AMPLIFY LEDGER excerpt: {"ts": "2025-10-18T00:23:46Z", "event": "ANCHORED_RECEIPT_WRITTEN", "source": "confirm_watcher_queue", "chain": "btc", "txid": "e92162d1ac6f56915d51a0b1435f1d203de98b3f102f92b2bc6052eec56e3d72", "height": 919569, "confirmations": 1, "session_meta_id": "AuditLogAI.REG.GlobalSubmission.v4034", "payload": "SENTINEL|SESSION|6fc7fef1cb6734cd5a3bb1147c25b756e9a41669|ef6556d6", "receipt": "receipt_anchored_AuditLogAI.REG.GlobalSubmission.v4034_e92162d1ac6f56915d51a0b1435f1d203de98 b3f102f92b2bc6052eec56e3d72_919569.json", "tier": "CRO", "unit_price_usd": 150, "source_job": "incoming_anchor_AuditLogAI.REG.GlobalSubmission.v4034_20251018T002015.559286Z.json"} Evidence File: ts_01_20_03_session_log_AuditLogAI.REG.GlobalSubmission.v4034_blockchain.com___20251 104T231150Z.png Page 19 of 69 HV_FT0019AUDITLOGAI_RUN15 Sentinel QMS v4 — Human-Executed Reproducibility Audit (RUN015) AuditLog.AI • Zero-Custody • OP_RETURN-Anchored © 2025 Cardiovascular Diagnostic Audit & AI Pty — Sentinel Protocol v4 QMS UTC (Audit Date): 2025-11-04 Session Log File: session_log_AuditLogAI.REG.GlobalSubmission.v4030_20251017T203831.645892Z.json REGULATORY-RUN ID: 007 Meta ID: AuditLogAI.REG.GlobalSubmission.v4030 UTC: 20251017T203831.645892Z SHA-256: 940277234a4293031780c7e627355221924b373f285212fd5baa1cff14568398 RIPEMD-160: ab212c3fb3a90d46bd09601574fdb69f92956075 Independent time attestation - OpenTimestamps.org: OTS Proof: session_log_AuditLogAI.REG.GlobalSubmission.v4030_20251017T203831.645892Z.hash.ots OTS SHA-256: 2e88723a6a1db6fd73675a29ec94b6aee07dc6c809d363edd349a2d2b213805b Non_Evidence_Screenshot 2025-11-09 at 8.51.20 am AMPLIFY LEDGER excerpt: {"ts": "2025-10-17T20:49:57Z", "event": "ANCHORED_RECEIPT_WRITTEN", "source": "confirm_watcher_queue", "chain": "btc", "txid": "e25f9fa07ea696c3cfc7cc903146149b8693aa0aacc00bd750be340d9d748f85", "height": 919553, "confirmations": 1, "session_meta_id": "AuditLogAI.REG.GlobalSubmission.v4030", "payload": "SENTINEL|SESSION|ab212c3fb3a90d46bd09601574fdb69f92956075|94027723", "receipt": "receipt_anchored_AuditLogAI.REG.GlobalSubmission.v4030_e25f9fa07ea696c3cfc7cc903146149b8693a a0aacc00bd750be340d9d748f85_919553.json", "tier": "CRO", "unit_price_usd": 150, "source_job": "incoming_anchor_AuditLogAI.REG.GlobalSubmission.v4030_20251017T203945.538832Z.json"} Evidence File: ts_01_20_14_session_log_AuditLogAI.REG.GlobalSubmission.v4030_blockchain.com___20251 104T231150Z.png Page 20 of 69 HV_FT0020AUDITLOGAI_RUN15 Sentinel QMS v4 — Human-Executed Reproducibility Audit (RUN015) AuditLog.AI • Zero-Custody • OP_RETURN-Anchored © 2025 Cardiovascular Diagnostic Audit & AI Pty — Sentinel Protocol v4 QMS UTC (Audit Date): 2025-11-04 Session Log File: session_log_AuditLogAI.REG.GlobalSubmission.v4026_20251017T202205.834235Z.json REGULATORY-RUN ID: 006 Meta ID: AuditLogAI.REG.GlobalSubmission.v4026 UTC: 20251017T202205.834235Z SHA-256: bc48e033cb27fc960620a2828821561b6817df140a5669700426384a23bba85e RIPEMD-160: 1f8661d7186f7721de804ebff1a18ab60c8113f0 Independent time attestation - OpenTimestamps.org: OTS Proof: session_log_AuditLogAI.REG.GlobalSubmission.v4026_20251017T202205.834235Z.hash.ots OTS SHA-256: 0e14659d22a2cd6c981a75a03c8458276c111cfd2142bfb3ce6c5ced602f3c44 Non_Evidence_Screenshot 2025-11-09 at 8.53.28 am AMPLIFY LEDGER excerpt: {"ts": "2025-10-17T20:30:26Z", "event": "ANCHORED_RECEIPT_WRITTEN", "source": "confirm_watcher_queue", "chain": "btc", "txid": "c86c7937da836997f4d2d0a9e23104ad519fe3eff5ddee25dbcbe592c2977d15", "height": 919552, "confirmations": 1, "session_meta_id": "AuditLogAI.REG.GlobalSubmission.v4026", "payload": "SENTINEL|SESSION|1f8661d7186f7721de804ebff1a18ab60c8113f0|bc48e033", "receipt": "receipt_anchored_AuditLogAI.REG.GlobalSubmission.v4026_c86c7937da836997f4d2d0a9e23104ad519fe 3eff5ddee25dbcbe592c2977d15_919552.json", "tier": "CRO", "unit_price_usd": 150, "source_job": "incoming_anchor_AuditLogAI.REG.GlobalSubmission.v4026_20251017T202430.733520Z.json"} Evidence File: ts_01_20_26_session_log_AuditLogAI.REG.GlobalSubmission.v4026_blockchain.com___20251 104T231150Z.png Page 21 of 69 HV_FT0021AUDITLOGAI_RUN15 Sentinel QMS v4 — Human-Executed Reproducibility Audit (RUN015) AuditLog.AI • Zero-Custody • OP_RETURN-Anchored © 2025 Cardiovascular Diagnostic Audit & AI Pty — Sentinel Protocol v4 QMS UTC (Audit Date): 2025-11-04 Session Log File: session_log_AuditLogAI.REG.GlobalSubmission.v4020_20251014T200606.551974Z.json REGULATORY-RUN ID: 005 Meta ID: AuditLogAI.REG.GlobalSubmission.v4020 UTC: 20251014T200606.551974Z SHA-256: 5c009fb3e680ca41e0e17aefe3bc931ec00b195e8faa0eb3f546d059930b0724 RIPEMD-160: 041cf98418a6ae39dbcc5d3e49e60a06a5112993 Independent time attestation - OpenTimestamps.org: OTS Proof: session_log_AuditLogAI.REG.GlobalSubmission.v4020_20251014T200606.551974Z.hash.ots OTS SHA-256: c26576aaa708bdb17285f011d1d9c7880a3e5f8f334d2a64ebc2511bf2f12c2a Non_Evidence_Screenshot 2025-11-09 at 8.55.30 am AMPLIFY LEDGER excerpt: {"ts": "2025-10-14T20:10:25Z", "event": "ANCHORED_RECEIPT_WRITTEN", "source": "confirm_watcher_queue", "chain": "btc", "txid": "d096197e02a8f1ac9ca7da43d353f109fe4ff72f6ae7f88b39c83877247e9ef7", "height": 919084, "confirmations": 1, "session_meta_id": "AuditLogAI.REG.GlobalSubmission.v4020", "payload": "SENTINEL|SESSION|041cf98418a6ae39dbcc5d3e49e60a06a5112993|5c009fb3", "receipt": "receipt_anchored_AuditLogAI.REG.GlobalSubmission.v4020_d096197e02a8f1ac9ca7da43d353f109fe4ff 72f6ae7f88b39c83877247e9ef7_919084.json", "tier": "CRO", "unit_price_usd": 150, "source_job": "incoming_anchor_AuditLogAI.REG.GlobalSubmission.v4020_20251014T200812.994407Z.json"} Evidence File: ts_01_20_39_session_log_AuditLogAI.REG.GlobalSubmission.v4020_blockchain.com___20251 104T231150Z.png Page 22 of 69 HV_FT0022AUDITLOGAI_RUN15 Sentinel QMS v4 — Human-Executed Reproducibility Audit (RUN015) AuditLog.AI • Zero-Custody • OP_RETURN-Anchored © 2025 Cardiovascular Diagnostic Audit & AI Pty — Sentinel Protocol v4 QMS UTC (Audit Date): 2025-11-04 Session Log File: session_log_AuditLogAI.REG.GlobalSubmission.v4016_20251014T194515.612758Z.json REGULATORY-RUN ID: 004 Meta ID: AuditLogAI.REG.GlobalSubmission.v4016 UTC: 20251014T194515.612758Z SHA-256: 2b44af1d4888f598c89dec992b6ce31d6fc0daab7a2480a3efb07d44bf3eb055 RIPEMD-160: f63523aba83a6b47c8fbb5dd942d20ef6aa7ee3e Independent time attestation - OpenTimestamps.org: OTS Proof: session_log_AuditLogAI.REG.GlobalSubmission.v4016_20251014T194515.612758Z.hash.ots OTS SHA-256: c6df3b2bf6a8b3e13c40f2139f61b2dd7440b8e2a10a321c86b891b3626c2c0b Non_Evidence_Screenshot 2025-11-09 at 8.57.16 am AMPLIFY LEDGER excerpt: {"ts": "2025-10-14T19:54:44Z", "event": "ANCHORED_RECEIPT_WRITTEN", "source": "confirm_watcher_queue", "chain": "btc", "txid": "9a46014d657726798449cc6282de083e2084afc87aa5f23233903396d73b8d4f", "height": 919082, "confirmations": 1, "session_meta_id": "AuditLogAI.REG.GlobalSubmission.v4016", "payload": "SENTINEL|SESSION|f63523aba83a6b47c8fbb5dd942d20ef6aa7ee3e|2b44af1d", "receipt": "receipt_anchored_AuditLogAI.REG.GlobalSubmission.v4016_9a46014d657726798449cc6282de083e2084a fc87aa5f23233903396d73b8d4f_919082.json", "tier": "CRO", "unit_price_usd": 150, "source_job": "incoming_anchor_AuditLogAI.REG.GlobalSubmission.v4016_20251014T195206.714055Z.json"} Evidence File: ts_01_20_52_session_log_AuditLogAI.REG.GlobalSubmission.v4016_blockchain.com___20251 104T231150Z.png Page 23 of 69 HV_FT0023AUDITLOGAI_RUN15 Sentinel QMS v4 — Human-Executed Reproducibility Audit (RUN015) AuditLog.AI • Zero-Custody • OP_RETURN-Anchored © 2025 Cardiovascular Diagnostic Audit & AI Pty — Sentinel Protocol v4 QMS UTC (Audit Date): 2025-11-04 Session Log File: session_log_AuditLogAI.REG.GlobalSubmission.v4009_20251013T034508.120256Z.json REGULATORY-RUN ID: 003 Meta ID: AuditLogAI.REG.GlobalSubmission.v4009 UTC: 20251013T034508.120256Z SHA-256: 862010c85fda0bfb02be23bb4316eea13966d374e60baa271f6292ef9416604b RIPEMD-160: 7e37072aeb1f857fb3245d9cdadc80356ff8563f Independent time attestation - OpenTimestamps.org: OTS Proof: session_log_AuditLogAI.REG.GlobalSubmission.v4009_20251013T034508.120256Z.hash.ots OTS SHA-256: aa327f72e2799c98a4f1ea5ff83cda1fc2cf4b9670d90072d865f9cfa53d6bfd Non_Evidence_Screenshot 2025-11-09 at 8.58.48 am AMPLIFY LEDGER excerpt: {"ts": "2025-10-13T04:17:39Z", "event": "ANCHORED_RECEIPT_WRITTEN", "source": "confirm_watcher_queue", "chain": "btc", "txid": "413a692f24f58970cf72fdabec58095d2b7599b5cb1325303cc6d19ec89ddb01", "height": 918808, "confirmations": 1, "session_meta_id": "AuditLogAI.REG.GlobalSubmission.v4009", "payload": "SENTINEL|SESSION|7e37072aeb1f857fb3245d9cdadc80356ff8563f|862010c8", "receipt": "receipt_anchored_AuditLogAI.REG.GlobalSubmission.v4009_413a692f24f58970cf72fdabec58095d2b759 9b5cb1325303cc6d19ec89ddb01_918808.json", "tier": "CRO", "unit_price_usd": 150, "source_job": "incoming_anchor_AuditLogAI.REG.GlobalSubmission.v4009_20251013T034642.343523Z.json"} Evidence File: ts_01_21_04_session_log_AuditLogAI.REG.GlobalSubmission.v4009_blockchain.com___20251 104T231150Z.png Page 24 of 69 HV_FT0024AUDITLOGAI_RUN15 Sentinel QMS v4 — Human-Executed Reproducibility Audit (RUN015) AuditLog.AI • Zero-Custody • OP_RETURN-Anchored © 2025 Cardiovascular Diagnostic Audit & AI Pty — Sentinel Protocol v4 QMS UTC (Audit Date): 2025-11-04 Session Log File: session_log_AuditLogAI.REG.GlobalSubmission.v4005_20251012T204520.780899Z.json REGULATORY-RUN ID: 002 Meta ID: AuditLogAI.REG.GlobalSubmission.v4005 UTC: 20251012T204520.780899Z SHA-256: 7c61fb5ed56a98ae79a8dcf55d582b4d9200596daa4080d37c08cfe86a8e4bcb RIPEMD-160: 5c5635ccbed45827cd437b67c60020742cc19c1b Independent time attestation - OpenTimestamps.org: OTS Proof: session_log_AuditLogAI.REG.GlobalSubmission.v4005_20251012T204520.780899Z.hash.ots OTS SHA-256: 272dc558efd701e50b4bd63eca1d9008cc2efa449de9f8053294027e74010877 Non_Evidence_Screenshot 2025-11-09 at 9.00.36 am AMPLIFY LEDGER excerpt: {"ts": "2025-10-12T20:49:42Z", "event": "ANCHORED_RECEIPT_WRITTEN", "source": "confirm_watcher_queue", "chain": "btc", "txid": "02f71288b6f45b9527ccf8714e4d1bfa697dbb45bcda83bb93a451c81cce439c", "height": 918772, "confirmations": 1, "session_meta_id": "AuditLogAI.REG.GlobalSubmission.v4005", "payload": "SENTINEL|SESSION|5c5635ccbed45827cd437b67c60020742cc19c1b|7c61fb5e", "receipt": "receipt_anchored_AuditLogAI.REG.GlobalSubmission.v4005_02f71288b6f45b9527ccf8714e4d1bfa697db b45bcda83bb93a451c81cce439c_918772.json", "tier": "CRO", "unit_price_usd": 150, "source_job": "incoming_anchor_AuditLogAI.REG.GlobalSubmission.v4005_20251012T204707.939845Z.json"} Evidence File: ts_01_21_16_session_log_AuditLogAI.REG.GlobalSubmission.v4005_blockchain.com___20251 104T231150Z.png Page 25 of 69 HV_FT0025AUDITLOGAI_RUN15 Sentinel QMS v4 — Human-Executed Reproducibility Audit (RUN015) AuditLog.AI • Zero-Custody • OP_RETURN-Anchored © 2025 Cardiovascular Diagnostic Audit & AI Pty — Sentinel Protocol v4 QMS UTC (Audit Date): 2025-11-04 Regulatory References Independent Positive Control 3: https://www.fda.gov/media/75414/download Purpose: Public FDA source link for the canonical Part 11 – Electronic Records; Electronic Signatures guidance. Independent Negative Control Sources Definition: Independent third-party sources used to demonstrate expected hash mismatches resulting from controlled metadata or rendering-layer changes. These negative controls confirm the sensitivity and specificity of the dual-hash verification process by showing that both content and non-content metadata alterations are correctly detected as mismatches. Ordinal 12 Independent Negative Control (content): ResearchGate: [10.13140/RG.2.2.22888.94726](https://doi.org/10.13140/RG.2.2.22888.94726) Purpose: A dual-hash mismatch is expected due to metadata page insertion performed automatically by the ResearchGate platform. Regulatory References Independent Negative Control (metadata): https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11 Purpose: A dual-hash mismatch is expected due to de novo PDF generation and metadata insertion by ecfr.gov during export. The discrepancy is limited to file-level metadata and does not represent a content change. Page 32 of 69 HV_FT0032AUDITLOGAI_RUN15 Sentinel QMS v4 — Human-Executed Reproducibility Audit (RUN015) AuditLog.AI • Zero-Custody • OP_RETURN-Anchored © 2025 Cardiovascular Diagnostic Audit & AI Pty — Sentinel Protocol v4 QMS UTC (Audit Date): 2025-11-04 Fraud Detection Testing – Metadata Negative Control Metadata-Level Negative Control Fraud Detection Demonstration Methodology Description: Controlled modifications were performed at the metadata layer only to demonstrate frauddetection capabilities and reproducibility integrity. No changes were made to the file’s substantive contents. Procedure: Edits were executed using the canonical utility: auditlog.ai_metadata___20251104T063215Z.py SHA-256: 60037da2c054d7b231736a23914a2d47b68b798b720843999c8691a395d1a862 RIPEMD-160: c30214bd2cca14865714d25b4c6fb5089840cfb8 Purpose: Although the file contents remain identical, a hash mismatch is expected due to controlled metadata-level alterations. This serves as a valid negative control for fraud detection and hash integrity validation. Canonical Positive Control Sources Definition: Frozen evidence files were manually duplicated (copied and pasted) within the local file system. Only the filename and storage location changed; file bytes remained identical. Method: After manual duplication, SHA-256 and RIPEMD-160 hashes were recomputed and compared to the original. Purpose: Dual-hash match expected (exact equality). Any mismatch would indicate modification beyond filename/path. Page 33 of 69 HV_FT0033AUDITLOGAI_RUN15 Sentinel QMS v4 — Human-Executed Reproducibility Audit (RUN015) AuditLog.AI • Zero-Custody • OP_RETURN-Anchored © 2025 Cardiovascular Diagnostic Audit & AI Pty — Sentinel Protocol v4 QMS UTC (Audit Date): 2025-11-04 Additional Positive Controls (Executed in REGULATORY-RUN012) Definition: Additional positive control verifications executed under REGULATORY-RUN012, confirming reproducibility of previously anchored frozen session logs and official FDA regulatory references. All files were rehashed using dual-algorithm verification (SHA-256 + RIPEMD-160) and compared against their original canonical digests to validate immutability across re-archival and duplication events. Frozen Session Logs (REGULATORY-RUNs 1-11): Re-verification of frozen session log archives from REGULATORY-RUNs 001 – 011. Each log was manually duplicated, frozen, and rehashed to confirm byte-level identity with the canonical ledger entries. Evidence Files: • session_log_AuditLogAI.REG.GlobalSubmission.v4038_20251018T214519.997259Z___202 51026T094829Z.json • session_log_AuditLogAI.REG.GlobalSubmission.v4034_20251018T001855.666955Z___202 51026T094829Z.json • session_log_AuditLogAI.REG.GlobalSubmission.v4020_20251014T200606.551974Z___202 51026T094829Z.json • session_log_AuditLogAI.REG.GlobalSubmission.v4009_20251013T034508.120256Z___202 51026T094829Z.json • session_log_AuditLogAI.REG.GlobalSubmission.v4030_20251017T203831.645892Z___202 51026T094829Z.json • session_log_AuditLogAI.REG.GlobalSubmission.v4005_20251012T204520.780899Z___202 51026T094829Z.json • session_log_AuditLogAI.REG.GlobalSubmission.v4051_20251026T085338.849295Z___202 51026T094829Z.json • session_log_AuditLogAI.REG.GlobalSubmission.v4016_20251014T194515.612758Z___202 51026T094829Z.json • session_log_AuditLogAI.REG.GlobalSubmission.v4042_20251020T194225.497227Z___202 51026T094829Z.json • session_log_AuditLogAI.REG.GlobalSubmission.v4026_20251017T202205.834235Z___202 51026T094829Z.json • session_log_AuditLogAI.REG.GlobalSubmission.v4001_20251012T200455.617478Z___202 51026T094829Z.json Page 34 of 69 HV_FT0034AUDITLOGAI_RUN15 Sentinel QMS v4 — Human-Executed Reproducibility Audit (RUN015) AuditLog.AI • Zero-Custody • OP_RETURN-Anchored © 2025 Cardiovascular Diagnostic Audit & AI Pty — Sentinel Protocol v4 QMS UTC (Audit Date): 2025-11-04 Manifest Reference: All SHA-256 and RIPEMD-160 digests for these session logs are compiled in manifest_AUDIT_frozen_sources_REGULATORY-RUN-20251026-S02.csv, included within the frozen REGULATORY-RUN15 evidence archive. Official FDA Regulatory References: Re-verification of canonical U.S. FDA reference files used for cross-validation of regulatory integrity and document provenance within the AuditLog.AI Global Compliance Matrix. Evidence Files: • HV_TELLES_58358119fnl_Canonical___20251026T085116Z.pdf • HV_TELLES_Part-11--Electronic-Records--Electronic-Signatures---Scope-and-Application- (PDF)_Canonical___20251026T085116Z.pdf • HV_TELLES_7883441_DataIntegrity_Canonical___20251026T085116Z.pdf • HV_TELLES_21 CFR Part 11 (up to date as of 9-292025)_Canonical___20251026T085116Z.pdf Manifest Reference: All SHA-256 and RIPEMD-160 digests are compiled in manifest_Global_Regulatory_Submission_BuildFiles_REGULATORY-RUN-20251026-S18.csv, included within the frozen REGULATORY-RUN15 evidence archive. Page 35 of 69 HV_FT0035AUDITLOGAI_RUN15 Sentinel QMS v4 — Human-Executed Reproducibility Audit (RUN015) AuditLog.AI • Zero-Custody • OP_RETURN-Anchored © 2025 Cardiovascular Diagnostic Audit & AI Pty — Sentinel Protocol v4 QMS UTC (Audit Date): 2025-11-04 AUDIT RESULTS Definition: All evidence packages were verified using the dual-hash public verification toolset. Validated outputs for each audit stream were automatically exported to hash_audit_report.csv within the corresponding evidence directory, included within the frozen REGULATORY-RUN15 evidence archive. Preand Post-Execution Evidence (Human + System Validation Layers) Definition: This section provides visual confirmation of both the human-verified execution environment and the system-logged batch state captured during the 04 November 2025 reproducibility audit. Together, these frames constitute the Tier 1 (Human) and Tier 2 (System) validation layers that establish provenance integrity for this audit cycle. Tier 1 — Human Execution Screenshots Audit Status: PASS • Human-executed reproducibility validation confirmed Verifier: Dr. Fernando Telles PreHuman Audit Execution Screenshot Evidence File: Screenshot 2025-11-04 at 4.01.13 pm___20251104T063220Z.png Description: Pre-execution screenshot captured immediately prior to human audit initiation. Observation: Displays terminal idle state and prepared validation directories, confirming controlled start conditions. Outcome: Baseline human-audit environment verified – PASS. Page 36 of 69 HV_FT0036AUDITLOGAI_RUN15 Sentinel QMS v4 — Human-Executed Reproducibility Audit (RUN015) AuditLog.AI • Zero-Custody • OP_RETURN-Anchored © 2025 Cardiovascular Diagnostic Audit & AI Pty — Sentinel Protocol v4 QMS UTC (Audit Date): 2025-11-04 PostHuman Audit Execution Screenshot Evidence File: Screenshot 2025-11-04 at 5.29.15 pm___20251104T063215Z.png Description: Post-execution screenshot captured immediately following completion of human audit sequence. Observation: Shows validated outputs, exported reports, and updated evidence directories confirming full audit cycle completion. Outcome: Human-audit session concluded successfully – PASS. Tier 2 — System-Generated Batch Screenshots (REGULATORYRUN-015) Audit Status: PASS • Baseline environment integrity confirmed • All manifest CSV files for REGULATORY-RUN-015 registered • Controlled execution confirmed within Δ ≤ 300 seconds threshold Verifier: Dr. Fernando Telles Page 37 of 69 HV_FT0037AUDITLOGAI_RUN15 Sentinel QMS v4 — Human-Executed Reproducibility Audit (RUN015) AuditLog.AI • Zero-Custody • OP_RETURN-Anchored © 2025 Cardiovascular Diagnostic Audit & AI Pty — Sentinel Protocol v4 QMS UTC (Audit Date): 2025-11-04 Pre-Hashing Execution Screenshot Evidence File: PRE_20251104T063214Z Description: System-captured screenshot recording the PRE state immediately before hashing begins (human authorization for capture is mandatory). Observation: Environment baseline recorded showing pre-inventory audit, files queued for processing, and timestamp metadata. Outcome: Baseline environment integrity confirmed – PASS. PostHashing Execution Screenshot Evidence File: POST_20251104T063226Z Description: System-captured screenshot following dual-hasher execution. Observation: All manifest CSV files for REGULATORY-RUN-015 registered, compiling SHA-256 and RIPEMD-160 digests for all frozen evidence files in this audit. Outcome: Controlled execution confirmed within Δ ≤ 300 seconds threshold – PASS. Page 38 of 69 HV_FT0038AUDITLOGAI_RUN15 Sentinel QMS v4 — Human-Executed Reproducibility Audit (RUN015) AuditLog.AI • Zero-Custody • OP_RETURN-Anchored © 2025 Cardiovascular Diagnostic Audit & AI Pty — Sentinel Protocol v4 QMS UTC (Audit Date): 2025-11-04 Reference Note: The Tier 2 screenshots were automatically captured by AuditLog.AI under REGULATORY-RUN015. The accompanying session_global_REGULATORY-RUN-20251104.json file was generated immediately after the post-execution capture and hashing. It serves as a lightweight session manifest linking the paired PRE and POST screenshots, their SHA-256 / RIPEMD-160 digests, and UTC capture times. Session global contents: ```json { "run_id": "REGULATORY-RUN-20251104", "session_context": "AuditLogAI.REG.GlobalSubmission.v4-RUN-20251104-S01", "pre": {"path": "/Users/rosmontos/AuditLog.AI_UserSimulation_SentinelProtocolv4_AIHumanSynergy/validation_bat ch_stream/REGULATORY-RUN15_AuditLog.AI_REPRODUCIBILITY_Evidence/frozen_sources/REGULATORYRUN-20251104/screenshots/PRE_20251104T063214Z.png", "sha256": "f7d7ed0fcfecddaa875a82108a778eec1790492cbb232aa668b576b3b8a2e2a2", "ripemd160_sha256": "bccf680e86d6d93f22c99efd4270ef480bf239b7"}, "post": {"path": "/Users/rosmontos/AuditLog.AI_UserSimulation_SentinelProtocolv4_AIHumanSynergy/validation_bat ch_stream/REGULATORY-RUN15_AuditLog.AI_REPRODUCIBILITY_Evidence/frozen_sources/REGULATORYRUN-20251104/screenshots/POST_20251104T063226Z.png", "sha256": "3421502e316ef3994fd9bf1606f1962b689a5fad1a5ee1b85fe29182397609bc", "ripemd160_sha256": "44b720bddd1d0015dd09869aca7e2c922914671f"}, "generated_at_utc": "20251104T063227Z" } ``` Relocation Warning Verification Description: A non-blocking “Failed to relocate original to processed” warning was logged when the pipeline attempted to relocate Canonical Session Logs. Evidence File: Terminal_Session_v4059_Warning_Verification.md Note: Executed during post-hoc verification. Formal registration under REGULATORY-RUN017. Select CLI output excerpt: (Full command log preserved in evidence file) RUN-20251104S13/canonical/session_log_AuditLogAI.REG.GlobalSubmission.v4059_20251027T231229.358107Z___202 51104T063215Z.json -r--r--r-- 1 rosmontos staff uchg 38505 28 Oct 10:12 Observation: 1. MacOS uchg (locally immutable) flags were previously applied to canonical files during the original session processing (v4059 example: “-r--r--r-- 1 rosmontos staff uchg 38505 28 Oct 10:12”; timestamp 20251027T231229.358107Z). These immutable flags prevented file relocation during re-processing in RUN015, producing the warning. 2. As the files names were modified and VALIS-compliant, CME Rule 4a (VALIS filename standard) permitted dual-hashing to proceed as expected. 3. Canonical session logs were successfully registered in manifest_02_FROZEN_SESSION_LOGS_REGULATORY-RUN-20251104-S13.csv 4. Reproducibility confirmed: canonical and positive-control artifacts are byte-identical. Only filenames and directory paths differ; SHA-256 and RIPEMD-160 digests match. Outcome: The warning reflects standard “frozen artifact” protections (uchg) applied by AuditLog.AI. No impact on reproducibility, data integrity, CME Rule 4a (VALIS filename standard) compliance, or Δ≤300-second threshold – PASS. Page 39 of 69 HV_FT0039AUDITLOGAI_RUN15 Sentinel QMS v4 — Human-Executed Reproducibility Audit (RUN015) AuditLog.AI • Zero-Custody • OP_RETURN-Anchored © 2025 Cardiovascular Diagnostic Audit & AI Pty — Sentinel Protocol v4 QMS UTC (Audit Date): 2025-11-04 01 Primary Ordinals Ordinal 11 Canonical Audit Status: PASS • Dual-hash SHA256 & RIPEMD160 match on CANONICAL file Verifier: Dr. Fernando Telles CLI output excerpt: rosmontos@Fernandos-Mac-Studio Hash_validation % python3 extract_hashes.py 📁 Enter full path to directory containing `.hash` and `.2ha` files: >>> /Users/rosmontos/AuditLog.AI_UserSimulation_SentinelProtocolv4_AIHumanSynergy/validation_batc h_stream/REGULATORYRUN15_AuditLog.AI_REPRODUCIBILITY_Evidence/01_PRIMARY_ORDINALS/Ordinal_11/canonical ✅ Extracted Hash Summary: Filename SHA256 RIPEMD160 --------------------------------------------------------------------------------------------- ----------------------------------------------- AuditLog.AI_Runtime_Execution_and_System_Validation_Evidence_Dossier_CANONICAL.pdf fc46851b4854ca45798b741c0fb001eaa0945eb73c98795900c87939acb30d8a b0c8b2223eab705cac6bf7801b64945f7ed47022 📄 Exported summary to: /Users/rosmontos/AuditLog.AI_UserSimulation_SentinelProtocolv4_AIHumanSynergy/validation_batc h_stream/REGULATORYRUN15_AuditLog.AI_REPRODUCIBILITY_Evidence/01_PRIMARY_ORDINALS/Ordinal_11/canonical/hash_audi t_report.csv Ordinal 11 Fraud Detection Testing Negative Control (metadata) Audit Status: PASS • Dual-hash SHA256 & RIPEMD160 mismatch on Fraud Detection Testing (metadata) Verifier: Dr. Fernando Telles CLI output excerpt: rosmontos@Fernandos-Mac-Studio Hash_validation % python3 extract_hashes.py 📁 Enter full path to directory containing `.hash` and `.2ha` files: >>> /Users/rosmontos/AuditLog.AI_UserSimulation_SentinelProtocolv4_AIHumanSynergy/validation_batc h_stream/REGULATORYRUN15_AuditLog.AI_REPRODUCIBILITY_Evidence/01_PRIMARY_ORDINALS/Ordinal_11/negative_control ✅ Extracted Hash Summary: Filename SHA256 RIPEMD160 --------------------------------------------------------------------------------------------- ----------------------------------------------- NC_MetaData_AuditLog.AI_Runtime_Execution_and_System_Validation_Evidence_Dossier.2.pdf b2baa35a5f4f8eb5aaff80670f54bd478101923b84cebd06743c83b734a37fb1 561c59a1f27b79a5aafe399228c52c239422efdb 📄 Exported summary to: /Users/rosmontos/AuditLog.AI_UserSimulation_SentinelProtocolv4_AIHumanSynergy/validation_batc h_stream/REGULATORYRUN15_AuditLog.AI_REPRODUCIBILITY_Evidence/01_PRIMARY_ORDINALS/Ordinal_11/negative_control/ha sh_audit_report.csv Page 40 of 69 HV_FT0040AUDITLOGAI_RUN15 Sentinel QMS v4 — Human-Executed Reproducibility Audit (RUN015) AuditLog.AI • Zero-Custody • OP_RETURN-Anchored © 2025 Cardiovascular Diagnostic Audit & AI Pty — Sentinel Protocol v4 QMS UTC (Audit Date): 2025-11-04 Evidence File: ts_00_28_13_ORDINAL11_NC_MetaData_Insertion_auditlog.ai_metadata___20251104T23115 0Z.png Description: Negative-control metadata insertion (tool view). Observation: Shows provenance of meta insertion for Ordinal 11 copy. Outcome: Integrity validation – PASS (expected mismatch). Evidence File: ts_00_28_31_NC_MetaData_Ordinal11_DataView___20251104T231150Z.png Description: Finder/data view of Ordinal 11 NC file after meta insertion. Observation: Confirms altered file object and timestamps. Outcome: Integrity validation – PASS (mismatch expected). Page 41 of 69 HV_FT0041AUDITLOGAI_RUN15 Sentinel QMS v4 — Human-Executed Reproducibility Audit (RUN015) AuditLog.AI • Zero-Custody • OP_RETURN-Anchored © 2025 Cardiovascular Diagnostic Audit & AI Pty — Sentinel Protocol v4 QMS UTC (Audit Date): 2025-11-04 Evidence File: ts_00_00_31_Frozen_Session_Logs_Canonical___20251104T231150Z.png Description: Canonical folder of frozen session logs. Observation: Finder view shows unmodified canonical set. Outcome: Baseline confirmation – PASS. Evidence File: ts_01_09_51_AUDIT_PASS_VScode_VisualDiff_Session_Log_v4001_SHA256___20251104T2 31150Z.png Description: VS Code diff highlighting SHA-256 parity for session log v4001. Observation: Highlighted digest strings match canonical; search bar shows four identical SHA256 matches. Outcome: Integrity validation – PASS. Page 48 of 69 HV_FT0048AUDITLOGAI_RUN15 Sentinel QMS v4 — Human-Executed Reproducibility Audit (RUN015) AuditLog.AI • Zero-Custody • OP_RETURN-Anchored © 2025 Cardiovascular Diagnostic Audit & AI Pty — Sentinel Protocol v4 QMS UTC (Audit Date): 2025-11-04 Evidence File: ts_01_09_51_AUDIT_VScode_VisualDiff_Session_Log_v4001_SHA256_Canonical___2025110 4T231150Z.png Description: Canonical view (comparison context) for session log v4001 SHA-256. Observation: Search bar engaged, SHA-256 match 2 of 4 displayed. Outcome: SHA-256 reproducibility validated – PASS. Evidence File: ts_01_09_52_AUDIT_VScode_VisualDiff_Session_Log_v4001_SHA256_PC_PublicRepository_ __20251104T231150Z.png Description: Public-repo positive control parity for session log v4001 SHA-256. Observation: Digest equality between canonical and public copy, SHA-256 match 4 of 4 Outcome: Positive-control parity – PASS. Page 49 of 69 HV_FT0049AUDITLOGAI_RUN15 Sentinel QMS v4 — Human-Executed Reproducibility Audit (RUN015) AuditLog.AI • Zero-Custody • OP_RETURN-Anchored © 2025 Cardiovascular Diagnostic Audit & AI Pty — Sentinel Protocol v4 QMS UTC (Audit Date): 2025-11-04 Evidence File: ts_01_10_00_AUDIT_VScode_VisualDiff_Session_Log_v4001_RIPEMD160_Canonical___2025 1104T231150Z.png Description: Canonical RIPEMD-160 digest for session log v4001. Observation: Baseline digest visible for comparison with search bar revealing five identical RIPEMD-160 matches (additional match corresponding to AMPLIFY LEDGER payload). Outcome: Reference frame – PASS. Evidence File: ts_01_10_02_AUDIT_PASS_VScode_VisualDiff_Session_Log_v4001_RIPEMD160___2025110 4T231150Z.png Description: VS Code diff confirming RIPEMD-160 parity for session log v4001. Observation: Digests match between sources, RIPEMD-160 matches 1 & 2 of 5 highlighted. Outcome: Payload and AMPLIFY LEDGER parity – PASS. Page 50 of 69 HV_FT0050AUDITLOGAI_RUN15 Sentinel QMS v4 — Human-Executed Reproducibility Audit (RUN015) AuditLog.AI • Zero-Custody • OP_RETURN-Anchored © 2025 Cardiovascular Diagnostic Audit & AI Pty — Sentinel Protocol v4 QMS UTC (Audit Date): 2025-11-04 Evidence File: ts_01_10_06_AUDIT_VScode_VisualDiff_Session_Log_v4001_RIPEMD160_PC_PublicReposit ory___20251104T231150Z.png Description: RIPEMD-160 parity with public-repo copy, match 5 of 5. Observation: Equality highlights across files. Outcome: Positive-control parity – PASS. Evidence File: ts_01_10_11_AUDIT_VScode_VisualDiff_Session_Log_v4001_RIPEMD160_PC_FrozenCopy_ __20251104T231150Z.png Description: RIPEMD-160 parity with frozen positive-control copy. Observation: Identical digests across sources, match 4 of 5 highlighted. Outcome: Positive-control parity – PASS. Page 51 of 69 HV_FT0051AUDITLOGAI_RUN15 Sentinel QMS v4 — Human-Executed Reproducibility Audit (RUN015) AuditLog.AI • Zero-Custody • OP_RETURN-Anchored © 2025 Cardiovascular Diagnostic Audit & AI Pty — Sentinel Protocol v4 QMS UTC (Audit Date): 2025-11-04 Session Logs Negative Controls – Minimal Content Alteration Audit Status: PASS • Dual-hash SHA256 & RIPEMD160 mismatch on all NEGATIVE CONTROL files Verifier: Dr. Fernando Telles CLI output excerpt: rosmontos@Fernandos-Mac-Studio Hash_validation % python3 extract_hashes.py 📁 Enter full path to directory containing `.hash` and `.2ha` files: >>> /Users/rosmontos/AuditLog.AI_UserSimulation_SentinelProtocolv4_AIHumanSynergy/validation_batc h_stream/REGULATORYRUN15_AuditLog.AI_REPRODUCIBILITY_Evidence/02_FROZEN_SESSION_LOGS/negative_control ✅ Extracted Hash Summary: Filename SHA256 RIPEMD160 --------------------------------------------------------------------------------------------- ----------------------------------------------- NC_session_log_AuditLogAI.REG.GlobalSubmission.v4001_20251012T200455.617478Z.json 86e24d52b972d6d663a5a01d3fe9a915ce4ed8287005c5decd849836ff71747b e35ba9400782b1be8f1ac0f76f86e670b7ffc824 NC2_session_log_AuditLogAI.REG.GlobalSubmission.v4030_20251017T203831.645892Z.json 8a65ba6b6396f05fbadc9228a8a6141436b52135a9163afaa16354447b9ddf99 e91ed178c54bd34299114d53316900bd5b51f0f1 📄 Exported summary to: /Users/rosmontos/AuditLog.AI_UserSimulation_SentinelProtocolv4_AIHumanSynergy/validation_batc h_stream/REGULATORYRUN15_AuditLog.AI_REPRODUCIBILITY_Evidence/02_FROZEN_SESSION_LOGS/negative_control/hash_audit _report.csv Evidence File: ts_00_35_36_NC_Session_log_v4001_PRE_modification___20251104T231150Z.png Description: PRE-modification snapshot for negative-control session log v4001 example. Observation: Baseline content view prior to change. Outcome: Control context – PASS. Page 52 of 69 HV_FT0052AUDITLOGAI_RUN15 Sentinel QMS v4 — Human-Executed Reproducibility Audit (RUN015) AuditLog.AI • Zero-Custody • OP_RETURN-Anchored © 2025 Cardiovascular Diagnostic Audit & AI Pty — Sentinel Protocol v4 QMS UTC (Audit Date): 2025-11-04 Evidence File: ts_00_35_37_NC_session_log_v4001_MinorContentModification___20251104T231150Z.png Description: Minor content change applied (negative control). Observation: Small edit introduced to JSON payload (v4001 changed to v.4001). Outcome: Expected hash change – PASS (mismatch). Evidence File: ts_01_13_23_AUDIT_VScode_VisualDiff_Session_Log_v4001_SHA256_NC_MinorModification ___20251104T231150Z.png Description: VS Code diff (SHA-256) after minor change. Observation: SHA-256 differs from canonical/PC, search bar engaged showing 1 of 1. Outcome: Negative-control detection – PASS. Page 53 of 69 HV_FT0053AUDITLOGAI_RUN15 Sentinel QMS v4 — Human-Executed Reproducibility Audit (RUN015) AuditLog.AI • Zero-Custody • OP_RETURN-Anchored © 2025 Cardiovascular Diagnostic Audit & AI Pty — Sentinel Protocol v4 QMS UTC (Audit Date): 2025-11-04 Evidence File: ts_01_13_27_AUDIT_VScode_VisualDiff_Session_Log_v4001_RIPEMD160_NC_MinorModifica tion___20251104T231150Z.png Description: VS Code diff (RIPEMD-160) after minor change. Observation: RIPEMD-160 mismatch confirmed, search bar engaged 1 of 1 displayed. Outcome: Negative-control detection – PASS. Session Logs Positive Controls – Frozen Copies Audit Status: PASS • Dual-hash SHA256 & RIPEMD160 match on all frozen copies POSITIVE CONTROL files Verifier: Dr. Fernando Telles CLI output excerpt: rosmontos@Fernandos-Mac-Studio Hash_validation % python3 extract_hashes.py 📁 Enter full path to directory containing `.hash` and `.2ha` files: >>> /Users/rosmontos/AuditLog.AI_UserSimulation_SentinelProtocolv4_AIHumanSynergy/validation_batc h_stream/REGULATORYRUN15_AuditLog.AI_REPRODUCIBILITY_Evidence/02_FROZEN_SESSION_LOGS/positive_control/Frozen_cop ies ✅ Extracted Hash Summary: Filename SHA256 RIPEMD160 --------------------------------------------------------------------------------------------- ----------------------------------------------- PC_session_log_AuditLogAI.REG.GlobalSubmission.v4001_20251012T200455.617478Z.json 298787323e3b46f9975bb1856bbb9b6f2a8d5eb677c4d9a9c949382744c66dc7 9da9157e665088e67a2dfbda5cb7140c3895eec8 PC_session_log_AuditLogAI.REG.GlobalSubmission.v4026_20251017T202205.834235Z.json bc48e033cb27fc960620a2828821561b6817df140a5669700426384a23bba85e 1f8661d7186f7721de804ebff1a18ab60c8113f0 Page 54 of 69 HV_FT0054AUDITLOGAI_RUN15 Sentinel QMS v4 — Human-Executed Reproducibility Audit (RUN015) AuditLog.AI • Zero-Custody • OP_RETURN-Anchored © 2025 Cardiovascular Diagnostic Audit & AI Pty — Sentinel Protocol v4 QMS UTC (Audit Date): 2025-11-04 PC_session_log_AuditLogAI.REG.GlobalSubmission.v4038_20251018T214519.997259Z.json 5af54564b05e7ae9c8e6b4c918ca19586ca3c7e58af6b72806fa08603b27e844 fb5e9fa9e3873fe2236eaf1c60c4fc7dd0968c5a PC_session_log_AuditLogAI.REG.GlobalSubmission.v4051_20251026T085338.849295Z.json 05a3e17dfc281b22d82edd943f2c00d8c928e585c17f8490b2894f52469ba629 e27980be020be1a3aa2533e0b15496d829fb7565 PC_session_log_AuditLogAI.REG.GlobalSubmission.v4055_20251026T094941.054455Z.json dddf0c692264e9790b1ec3498958eeb9e911a659a20edb666717df7b05d0f51d 1460fb9944c4291a75efb35be571df0161cb21a6 PC_session_log_AuditLogAI.REG.GlobalSubmission.v4030_20251017T203831.645892Z.json 940277234a4293031780c7e627355221924b373f285212fd5baa1cff14568398 ab212c3fb3a90d46bd09601574fdb69f92956075 PC_session_log_AuditLogAI.REG.GlobalSubmission.v4042_20251020T194225.497227Z.json 5c6899adad23ba9e5cbe2c1e57b2a11df3ac4d29f0fa2b27a9dc52b3993d859a 62906b9bc17efa60726d54455bbb00252384e01e PC_session_log_AuditLogAI.REG.GlobalSubmission.v4005_20251012T204520.780899Z.json 7c61fb5ed56a98ae79a8dcf55d582b4d9200596daa4080d37c08cfe86a8e4bcb 5c5635ccbed45827cd437b67c60020742cc19c1b PC_session_log_AuditLogAI.REG.GlobalSubmission.v4059_20251027T231229.358107Z.json db4451a879e62a1e34a14a6052a442172be6c8798aff163a9564a31beb768d21 d51e9af05a7b8f32db2f85ab0a76ea7e71cadede PC_session_log_AuditLogAI.REG.GlobalSubmission.v4016_20251014T194515.612758Z.json 2b44af1d4888f598c89dec992b6ce31d6fc0daab7a2480a3efb07d44bf3eb055 f63523aba83a6b47c8fbb5dd942d20ef6aa7ee3e PC_session_log_AuditLogAI.REG.GlobalSubmission.v4009_20251013T034508.120256Z.json 862010c85fda0bfb02be23bb4316eea13966d374e60baa271f6292ef9416604b 7e37072aeb1f857fb3245d9cdadc80356ff8563f PC_session_log_AuditLogAI.REG.GlobalSubmission.v4034_20251018T001855.666955Z.json ef6556d6a4b9d035a5f100560ab3ce17f10024551e3c0955f42b1f871496eae4 6fc7fef1cb6734cd5a3bb1147c25b756e9a41669 PC_session_log_AuditLogAI.REG.GlobalSubmission.v4020_20251014T200606.551974Z.json 5c009fb3e680ca41e0e17aefe3bc931ec00b195e8faa0eb3f546d059930b0724 041cf98418a6ae39dbcc5d3e49e60a06a5112993 PC_session_log_AuditLogAI.REG.GlobalSubmission.v4063_20251028T043856.544873Z.json c5a677fe7df22429186b03467c1fe26250d0f2f84de37aa2e35bee15d8eb9e66 fb8750a3fe40cae25e96b31b128778d59ee7bcda 📄 Exported summary to: /Users/rosmontos/AuditLog.AI_UserSimulation_SentinelProtocolv4_AIHumanSynergy/validation_batc h_stream/REGULATORYRUN15_AuditLog.AI_REPRODUCIBILITY_Evidence/02_FROZEN_SESSION_LOGS/positive_control/Frozen_cop ies/hash_audit_report.csv Session Logs Positive Controls – Public Repository Audit Status: PASS • Dual-hash SHA256 & RIPEMD160 match on public repository POSITIVE CONTROL files Verifier: Dr. Fernando Telles CLI output excerpt: rosmontos@Fernandos-Mac-Studio Hash_validation % python3 extract_hashes.py 📁 Enter full path to directory containing `.hash` and `.2ha` files: >>> /Users/rosmontos/AuditLog.AI_UserSimulation_SentinelProtocolv4_AIHumanSynergy/validation_batc h_stream/REGULATORYRUN15_AuditLog.AI_REPRODUCIBILITY_Evidence/02_FROZEN_SESSION_LOGS/positive_control/Public_Rep o ✅ Extracted Hash Summary: Filename SHA256 RIPEMD160 --------------------------------------------------------------------------------------------- ----------------------------------------------- Page 55 of 69 HV_FT0055AUDITLOGAI_RUN15 Sentinel QMS v4 — Human-Executed Reproducibility Audit (RUN015) AuditLog.AI • Zero-Custody • OP_RETURN-Anchored © 2025 Cardiovascular Diagnostic Audit & AI Pty — Sentinel Protocol v4 QMS UTC (Audit Date): 2025-11-04 PC_2_session_log_AuditLogAI.REG.GlobalSubmission.v4001_downloaded_04Nov.25.json 298787323e3b46f9975bb1856bbb9b6f2a8d5eb677c4d9a9c949382744c66dc7 9da9157e665088e67a2dfbda5cb7140c3895eec8 PC_2_session_log_AuditLogAI.REG.GlobalSubmission.v4034_downloaded_04Nov.25.json ef6556d6a4b9d035a5f100560ab3ce17f10024551e3c0955f42b1f871496eae4 6fc7fef1cb6734cd5a3bb1147c25b756e9a41669 📄 Exported summary to: /Users/rosmontos/AuditLog.AI_UserSimulation_SentinelProtocolv4_AIHumanSynergy/validation_batc h_stream/REGULATORYRUN15_AuditLog.AI_REPRODUCIBILITY_Evidence/02_FROZEN_SESSION_LOGS/positive_control/Public_Rep o/hash_audit_report.csv 03 Regulatory References FDA Regulatory References Canonicals Audit Status: PASS • Dual-hash SHA256 & RIPEMD160 match on all CANONICAL files Verifier: Dr. Fernando Telles CLI output excerpt: rosmontos@Fernandos-Mac-Studio Hash_validation % python3 extract_hashes.py 📁 Enter full path to directory containing `.hash` and `.2ha` files: >>> /Users/rosmontos/AuditLog.AI_UserSimulation_SentinelProtocolv4_AIHumanSynergy/validation_batc h_stream/REGULATORYRUN15_AuditLog.AI_REPRODUCIBILITY_Evidence/03_REGULATORY_REFERENCES_FDA/canonical ✅ Extracted Hash Summary: Filename SHA256 RIPEMD160 --------------------------------------------------------------------------------------------- ----------------------------------------------- Part-11--Electronic-Records--Electronic-Signatures---Scope-and-Application- (PDF)_CanonicalCopy.pdf 306013031df65004566799023444b3fd66d17dca72eea4c7eb5bacfd4a697ac5 aa7b324fc0b70d87aa93f025aa8b880ba5423812 21 CFR Part 11 (up to date as of 9-29-2025)_CanonicalCopy.pdf a721cc9c5ad0f500f5b12397fd465035df7b07e8c7fe046f987c126b9ccdf6da fa447cdd3463a300f2914b778557d1b93887f91f 58358119fnl_CanonicalCopy.pdf f74ce1b061edfa634aaf0a0b07a472995a6d215f310a562e17ae46c0b67b47a6 106461fc6b6129eb44751d305723b687d82d3f92 7883441_DataIntegrity_CanonicalCopy.pdf 1b5074c592ed75035022566b6e151c219b5b6349414beaf4229e73117a0997c6 666d647cf72cfd3943b2fb28551802d8d3f89209 📄 Exported summary to: /Users/rosmontos/AuditLog.AI_UserSimulation_SentinelProtocolv4_AIHumanSynergy/validation_batc h_stream/REGULATORYRUN15_AuditLog.AI_REPRODUCIBILITY_Evidence/03_REGULATORY_REFERENCES_FDA/canonical/hash_audit_ report.csv Page 56 of 69 HV_FT0056AUDITLOGAI_RUN15 Sentinel QMS v4 — Human-Executed Reproducibility Audit (RUN015) AuditLog.AI • Zero-Custody • OP_RETURN-Anchored © 2025 Cardiovascular Diagnostic Audit & AI Pty — Sentinel Protocol v4 QMS UTC (Audit Date): 2025-11-04 Evidence File: ts_00_09_35_FDA_Canonical___20251104T231150Z.png Description: Canonical frozen FDA reference set displayed. Observation: Manual copy & paste methodology, followed by file name changes only. Outcome: Canonical frozen baseline demonstrated – PASS. Evidence File: ts_01_15_39_AUDIT_VScode_VisualDiff_FDA_RIPEMD160_Canonical_PC_Match___2025110 4T231150Z.png Description: VS Code parity check example for FDA file (RIPEMD-160). Observation: Canonical vs positive-control digests match, 2 of 3 matches highlighted. Outcome: Positive-control parity – PASS. Page 57 of 69 HV_FT0057AUDITLOGAI_RUN15 Sentinel QMS v4 — Human-Executed Reproducibility Audit (RUN015) AuditLog.AI • Zero-Custody • OP_RETURN-Anchored © 2025 Cardiovascular Diagnostic Audit & AI Pty — Sentinel Protocol v4 QMS UTC (Audit Date): 2025-11-04 Audit Recording Provenance Audit Log: audit_log_AuditLogAI.REG.GlobalSubmission.v4109_20251104T063526.760012Z.json Audit Meta ID: AuditLogAI.REG.GlobalSubmission.v4109 UTC: 20251104T063526.760012Z SHA-256: 422375e72c67966909b6c3b87ecda5c23f1f8c81394d810910ddaf222809335b RIPEMD-160: f025748d44ef62bb0108a80ae861bc50262d4913 Audit Log Contents: ```json [ { "timestamp": "2025-11-04T06:35:26.759459Z", "event": "AUDIT_BATCH_EVIDENCE_VERIFIED", "meta_id": "AuditLogAI.REG.GlobalSubmission.v4109", "input": { "batch_filenames": [ "execution/Screen Recording 2025-11-04 at 4.02.31\u202fpm___20251104T063215Z.mov" ], "evidence_type": "SHA256-RIPEMD160 reproducibility (deferred)", "session_context": "AuditLogAI.REG.GlobalSubmission.v4-RUN-20251104-S01", "batch_screenshot_pre": "PRE_20251104T063214Z.png", "batch_screenshot_post": "POST_20251104T063226Z.png", "validation_step": "valis_batchauditlogger_template_v3.1 active. Meta-ID: 05_SCREENSHOTS_RECORDINGS_REGULATORY-RUN-20251104-S20, 1 files, delta=12s. folder_dual_hash computed and checked.", "delta_seconds": 12, "executed_template": "valis_batchauditlogger_template_v3.1" }, "output": { "status": "verifiable", "verifiable": true, "final_hash_disclosed": false, "audit_type": "REPRODUCIBILITY", "meta_id": "AuditLogAI.REG.GlobalSubmission.v4-LOG05_SCREENSHOTS_RECORDINGS_REGULATORY-RUN-20251104-S20", "folder_dual_hash": "43f3eb6ce0e93828a71561a4770f4a449793b182" }, "audit": { "AI_used": true, "LLM_used": "LLM1", "human_verified": true, "module_version": "v.november04.25", "ai_editor_LLM_human_agreement": true, "VALIS_template_enforced": true, "reviewer": "Dr. Fernando Telles", "human_signature": { "signer": "DRTELLES", "decision": "approved", "reason": "batch verified; 1 files; \u0394=12s; PRE=PRE_20251104T063214Z.png; POST=POST_20251104T063226Z.png", "signed_at": "2025-11-04T06:35:26.759494Z" }, "AI_override": false }, "timestamp_confirmed": true } ] ``` OTS Proof: audit_log_AuditLogAI.REG.GlobalSubmission.v4109_20251104T063526.760012Z.hash.ots OTS SHA-256: 7fd725e2dc2bdd0bc2570b3e1f6217ee0939bf8163df19d67236a3cea4a64b69 OTS TXID: a03394fdb51c9a7d95675a3bc08b17d996a6a3d530b23bfd0e911b1a8b41c8c3 Block Height: 922144 Merkle Root: 72aa6d0df460eac1206659e7c920f534b49cdbfa1aa728d608d7dab510f0bb08 Page 64 of 69 HV_FT0064AUDITLOGAI_RUN15 Sentinel QMS v4 — Human-Executed Reproducibility Audit (RUN015) AuditLog.AI • Zero-Custody • OP_RETURN-Anchored © 2025 Cardiovascular Diagnostic Audit & AI Pty — Sentinel Protocol v4 QMS UTC (Audit Date): 2025-11-04 Date of Existence: 2025-11-04T07:22:22Z (Block 922144 UTC timestamp. Source: blockstream.info) Folder Meta ID: AuditLogAI.REG.GlobalSubmission.v4-LOG05_SCREENSHOTS_RECORDINGS_REGULATORY-RUN-20251104-S20 Folder RIPEMD-160: 43f3eb6ce0e93828a71561a4770f4a449793b182 Manifest CSV: manifest_05_SCREENSHOTS_RECORDINGS_REGULATORY-RUN20251104-S20.csv Provenance Anchoring Session Log: session_log_AuditLogAI.REG.GlobalSubmission.v4071_20251104T063550.007774Z.json REGULATORY-RUN ID: 015 Session Meta ID: AuditLogAI.REG.GlobalSubmission.v4071 UTC: 20251104T063550.007774Z SHA-256: 6936c54cc22e62ce5e43e46ed4453f61a4a500e68bf3a0f499f8dde0296d6c4b RIPEMD-160: 9820d4fea8db0fd96e576cabc3c3ac1f2f1bcb62 OTS Proof: session_log_AuditLogAI.REG.GlobalSubmission.v4071_20251104T063550.007774Z.hash.ots OTS SHA-256: 0a89f5b85f633a687fc16a85851fc36ad3b7fdf216a671c8a82c3ba61f8eb1b9 OTS TXID: a03394fdb51c9a7d95675a3bc08b17d996a6a3d530b23bfd0e911b1a8b41c8c3 Block Height: 922144 Merkle Root: 72aa6d0df460eac1206659e7c920f534b49cdbfa1aa728d608d7dab510f0bb08 Date of Existence: 2025-11-04T07:22:22Z (Bitcoin 922144 Block UTC timestamp. Source: blockstream.info) Bitcoin OP_RETURN Anchor Transaction ID: d2746ef74e5d678861b06018394af473ead923ce2ee589d527c2204cce8dc708 Payload: SENTINEL|SESSION|9820d4fea8db0fd96e576cabc3c3ac1f2f1bcb62|6936c54c Block Height: 922142 Bitcoin Public Ledger Time Attestation: 2025-11-04T06:52:24Z (Bitcoin Block 922142 UTC timestamp. Source: blockstream.info) Page 65 of 69 HV_FT0065AUDITLOGAI_RUN15 Sentinel QMS v4 — Human-Executed Reproducibility Audit (RUN015) AuditLog.AI • Zero-Custody • OP_RETURN-Anchored © 2025 Cardiovascular Diagnostic Audit & AI Pty — Sentinel Protocol v4 QMS UTC (Audit Date): 2025-11-04 Screenshot Provenance – Selected Frames from Execution Recording All screenshots cited in this report as evidence of audit execution and external verification (e.g. blockchain explorers, VS Code visual diffs, dualhasher/extract_hashes runs) are registered in REGULATORY-RUN016 in the following manifest evidence file: manifest_SelectedFrames_ExecutionScreenRecording_REGULATORY-RUN-20251104-S03.csv SHA-256: 85ef94e6c6815b62b00694839d0b30a24e5f32ffbc2e35bee74a404ede8135e9 RIPEMD-160: 7b51eb4a1569ad81d5b2e846f204ed0c00c9071c The full CSV is included in the frozen REGULATORY-RUN015 evidence archive and is available in the AuditLog.AI reproducibility repository (public): https://github.com/TELAISYN/AI-Human-Synergy File path within the repository: AuditLogAI.REG.GlobalSubmission.v4/REGULATORY-RUN015 Complete Provenance – Manifest CSVs (REGULATORY-RUN015) All manifest CSVs generated during REGULATORY-RUN015 (canonical, negative-control, and positive-control evidence sets; with associated .hash, .2ha, and .hash.ots sidecars) are also publicly available in the AuditLog.AI reproducibility repository. Manifests record, for each evidence file: • source context (src, meta_id, rel_path) • SHA-256 • RIPEMD-160(SHA-256) • VALIS-compliant frozen filename (frozen_name) To preserve readability and avoid unnecessary length, the manifest rows are not reproduced in this document. Their integrity can be independently verified by checking the manifest’s hashes against the published CSV. Page 66 of 69 HV_FT0066AUDITLOGAI_RUN15 Audit Plan — REGULATORY-RUN15 AuditLog.AI REPRODUCIBILITY EVIDENCE Software: AuditLog.AI Protocol: Sentinel Protocol QMS System: AI-Human Synergy™ Mode: Zero-Custody & Human-Verified Version: v4 Author: Dr Fernando Telles Date: 04 November 2025 Run ID: REGULATORY-RUN15 Operator: Dr Fernando Telles Recorder: Full-screen session recording (MacOs, primary monitor of dual-monitor setup, mouse clicks tracking enabled, microphone disabled) 1 • Purpose & Scope This run establishes the final, regulator-grade reproducibility audit for AuditLog.AI v4.0. It verifies that all prior anchored evidence (Ordinals 11 & 12, frozen session logs, and regulatory reference sets) remain reproducible and hash-parity consistent under human-verified reexecution using independent tools. Upon successful anchoring, this audit will serve as the definitive AuditLog.AI Reproducibility Proof included in all global regulatory submissions (FDA / EMA / TGA). Verification extends across: - Ordinal 11 Runtime Execution Dossier - Ordinal 12 Compliance Matrix - Frozen session logs (RUNs 01-14; v4001–v4063) - FDA / EMA / TGA official reference PDFs - Positive and negative control copies 2 • Objectives Re-execute dual-hash verification ( sha256 , ripemd160 ) for all canonical, positive, and negative controls. Confirm payload parity ( |ripemd160|sha8| ) with all recorded Bitcoin TXIDs. Validate that negative controls fail as expected. Freeze and anchor results under RUN 15 as the final audit artifact. 1. 2. 3. 4. Appendix A | Audit Plan | AuditLog.AI © Cardiovascular Diagnostic Audit & AI Pty Ltd | Sentinel QMS v4 | 2025-11-04 Page 67 of 69 HV_FT0067AUDITLOGAI_RUN15 3 • Audit Methodology Human Re-execution Steps Execute dualhasher_public_sentinel_v1.1.py → Generate dual-hashes (.hash , .2ha ) for each evidence file. Run extract_hashes.py → Generate manifests ( *.csv ) listing file, sha256, ripem‐ d160. Manually validate hash parity (VS Code visual diff + live recording). Extract payload from public blockchain explorer using AMPLIFY_LEDGER TXIDs. Validate session-log hashes against payload and ledger entries. Compile final Markdown summary report. Freeze folder; apply dual-hash, OpenTimestamps stamp, and anchor all audit evidence files in REGULATORY-RUN015. Verification Tools dualhasher_public_sentinel_v1.1.py___20250809T030248.075732Z (Ripemd160 c85ec8c5f4b364f08a00b351f8fca23577521d52 ; Sha256 f84abe5a7e000b‐ cd2e513092f91151edc3f73fa33654e51e925acf711a94e4f0 ) extract_hashes.py___20250809T030248.072046Z (Ripemd160 1769c85e6aefe249ba83ab61c3254b5fa002638c ; Sha256 a900d‐ f272130a8d3a55560993cb80d94a8f78bfbaf66f2bdff5684fcab296cbd ) Note: The hashing tools used in this audit (dualhasher_public_sentinel_v1.1.py and ex‐ tract_hashes.py) are open-source scripts that were previously registered and hashed in earlier SENTINFRA validation sessions. As these tools were not modified, and as they are publicly available in the AuditLog.AI repository, they were not re-hashed or included in the REGULAT‐ ORY-RUN015 manifest CSVs. Regulators may independently verify their integrity using the public source. Recording Protocol Continuous screen recording from folder overview to final hash output. Available to regulators on request (under NDA). Select frames from recording to be included in final PDF for clarity. 4 • Validation Criteria Category Expected Result Pass/Fail Logic Canonical Files Dual hash match + payload match Pass Positive Controls Dual hash match Pass 1. 2. 3. 4. 5. 6. 7. • • Appendix A | Audit Plan | AuditLog.AI © Cardiovascular Diagnostic Audit & AI Pty Ltd | Sentinel QMS v4 | 2025-11-04 Page 68 of 69 HV_FT0068AUDITLOGAI_RUN15 Category Expected Result Pass/Fail Logic Negative Controls Dual hash mismatch Pass (expected) Fraud Tests Detection of change via hash delta Pass (expected fail) 5 • Verification Targets Primary A1: Ordinal 11 – Runtime Execution Dossier Primary A2: Ordinal 12 – Global Compliance Matrix Primary A3: Frozen Session Logs (v4001 → v4063) Secondary B1: FDA Regulatory Reference Documents Controls: positive (+ve) / negative (–ve content & metadata) 6 • Deliverables AUDIT_REPRODUCIBILITY_<PASS/ FAIL>_AuditLog.AI_sha256_ripemd160_payload_TXID_v.04Nov.25.md (Audit report). Frozen archive with dual hash + OTS proofs. Video record of execution. Anchored TXID & block height record in AMPLIFY_LEDGER. Compilation of PDF conversions of AuditPlan_v.04Nov25.md (this document); and Fi‐ nal Audit report combined with select frames from video record of execution. Anchoring of select frames screenshots during live demonstration (Governance Advisor Demonstrations schedulled 05 November 2025, REGULATORY-RUN16) Individual evidence anchoring via OP_Return and Ordinal technology Open-Science Dual DOI publication 7 • Schedule Preparation: 29 October 2025 - 04 Nov 2025 05:00 UTC Execution: 04 Nov 2025 05:00 UTC to completion (uninterupted) Freeze + Anchor: Immediately upon completion 04 Nov 2025 Live Demonstration & Ordinal 13 PDF anchoring: Scheduled video call (Gov‐ ernance Advisor to AuditLog.AI Outreach) Wednesday, Nov 5 2025 – 10:00 – 10:30 AM AEST (00:00 – 00:30 AM UTC). • • • • • 1. 2. 3. 4. 5. 6. 7. 8. • • • • Appendix A | Audit Plan | AuditLog.AI © Cardiovascular Diagnostic Audit & AI Pty Ltd | Sentinel QMS v4 | 2025-11-04 Page 69 of 69 HV_FT0069AUDITLOGAI_RUN15