Published October 27, 2025 | Version v1
Software documentation Open

AuditLog.AI — Runtime Execution and System Validation Evidence Dossier | End‑to‑End Operational Proof During Regulatory Global Submission

Authors/Creators

  • 1. Cardiovascular Diagnostic Audit & AI Pty Ltd (CDA AI) ABN 19 638 019 431 | ACN 638 019 431
  • 2. Telles Investments Pty Ltd | ACN 638 017 384

Contributors

  • 1. Cardiovascular Diagnostic Audit & AI Pty Ltd (CDA AI) ABN 19 638 019 431 | ACN 638 019 431

Description

This document forms part of the AuditLog.AI Global Regulatory Submission Package (v4.0) — providing immutable, reproducible proof of execution for validation, compliance, and quality-assurance evidence across FDA, EMA, TGA, PCAOB, and ISA frameworks.
AuditLog.AI operates under the Sentinel Quality Management System (QMS) using a zero-custody model, ensuring that no raw data or identifiers ever leave the user’s environment.
Each audit event is cryptographically sealed (SHA-256 → RIPEMD-160), time-stamped through OpenTimestamps, and permanently anchored to the Bitcoin mainnet via OP_RETURN.
These anchors establish verifiable, regulator-grade proof of integrity, authenticity, and human-verified control.
Public verification of this artifact may be performed through any independent blockchain explorer using the transaction IDs and digests provided below.
This open-submission release aligns with the principles of transparency and reproducibility for digital audit systems, supporting global harmonization between Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and International Standards on Auditing (ISA).
It may be freely referenced in regulatory, clinical, or assurance contexts under citation of its dual DOI and associated Bitcoin anchors.

- File Reference: `AuditLog.AI_Runtime_Execution_and_System_Validation_Evidence_Dossier_FINAL_METADATA___20251027T231047Z.pdf`
- SHA-256: `fc46851b4854ca45798b741c0fb001eaa0945eb73c98795900c87939acb30d8a`
- RIPEMD-160: `b0c8b2223eab705cac6bf7801b64945f7ed47022`
- OTS File: `AuditLog.AI_Runtime_Execution_and_System_Validation_Evidence_Dossier_FINAL_METADATA___20251027T231047Z.pdf.hash.ots`
- OP_RETURN Anchor: `ORDINAL11|b0c8b2223eab705cac6bf7801b64945f7ed47022|fc46851b` | Transaction ID: `a09523a5e311d5e5213cba7cc39ec3a274aa1cc017be369cfa5786c3677a1540` | Block: `921107`
- Ordinal Anchor: `ORDINAL11|b0c8b2223eab705cac6bf7801b64945f7ed47022|fc46851b` | Transaction ID: `6754818e57d5dcc16a7fccdb1d36bb213cd39ae4a180e17923387738f38a3f41` | Block: `921109`

- Anchoring Session log: `session_log_AuditLogAI.REG.GlobalSubmission.v4059_20251027T231229.358107Z.json`
- SHA-256: `db4451a879e62a1e34a14a6052a442172be6c8798aff163a9564a31beb768d21`
- RIPEMD-160: `d51e9af05a7b8f32db2f85ab0a76ea7e71cadede`
- Session OTS File: `session_log_AuditLogAI.REG.GlobalSubmission.v4059_20251027T231229.358107Z.hash.ots`
- Session OP_RETURN Anchor: `SENTINEL|SESSION|d51e9af05a7b8f32db2f85ab0a76ea7e71cadede|db4451a8`
- Transaction ID: `06028cfbf809665838e437dcad6d01c48d5c4679ebdbe045ea12ed4c311c020e`
- Date of Existence (UTC): `2025-10-27T23:14:36Z` (TXID broadcast time confirming file existence as of Bitcoin block 921094.)

Files

AuditLog.AI_Runtime_Execution_and_System_Validation_Evidence_Dossier_FINAL_METADATA___20251027T231047Z.pdf

Files (23.5 MB)

Additional details

References

  • Telles, Fernando. *Sentinel Protocol v3.1 – Infrastructure Reproducibility and Public Verification Log.* CDA AI Pty Ltd, July 2025. DOI: [10.13140/RG.2.2.29180.65924](http://dx.doi.org/10.13140/RG.2.2.29180.65924) Zenodo: [10.5281/zenodo.16607606](https://doi.org/10.5281/zenodo.16607606)
  • Telles, Fernando. *Ordinal 06 – Immutable Verification of Infrastructure Audit Log (Ordinal 05) under Sentinel Protocol v3.1.* CDA AI Pty Ltd, July 2025. DOI: [10.13140/RG.2.2.21019.78882](http://dx.doi.org/10.13140/RG.2.2.21019.78882) Zenodo: [10.5281/zenodo.16777715](https://doi.org/10.5281/zenodo.16777715)