C12 – AuditLog.AI Global Compliance Matrix

C12 – AuditLog.AI Global Compliance Matrix provides the harmonized cross-reference between AuditLog.AI’s live runtime execution evidence and the governing clauses of FDA 21 CFR Part 11, EMA Annex 11, TGA / PIC/S PE 009-17, and international auditing standards (PCAOB AS 1105 / 1215 and ISA 230 / 500 / 240 Revised 2025). The matrix demonstrates that a single zero-custody, cryptographically anchored audit system can satisfy global validation, security, and documentation obligations across both regulatory and financial-assurance domains. All mapped evidence originates from the AuditLog.AI Runtime Execution and System Validation Evidence Dossier (DOI: [10.13140/RG.2.2.28551.25765] Zenodo: [10.5281/zenodo.17460850]), verified through UTC-synchronized timestamps, dual-hash proofs (SHA-256 + RIPEMD-160), OpenTimestamps attestation, and Bitcoin mainnet anchoring via OP_RETURN. Each clause is traceable to specific evidence items and session logs, ensuring reproducibility, human verification, and public auditability. The document establishes AuditLog.AI v4.0 as the first globally harmonized digital audit-trail system providing unified compliance alignment across FDA, EMA, TGA, PCAOB, and ISA standards. Ripemd160: fb1822a8113a1b691a7ef64bb7cd64ea2fa02bc8 Sha256: bbedad71af2064fb2456c73483984c538c66c2ed344f2a1cf34eef23cab14b81 Immutable Anchor: ORDINAL12|fb1822a8113a1b691a7ef64bb7cd64ea2fa02bc8|bbedad71 OP return: `e3dd84f739d2daf3f60177ce93e44648e9c57ef596090ef9a0474e0fc4fae326` ORDINAL: `7917e0f12fcff508d387733fd543451846316a21b16ca3f0d872b9849f94a904`