In regulated engineering and clinical safety, an assertion without verifiable evidence is mere conjecture. PMX OS elevates Evidence from an unlinked attachment or casual footnote into an immutable, first-class, cryptographically sealed object with full audit provenance and legal accountability.
How PMX OS transforms raw data, engineering memos, and bench test telemetry into legally defensible, audit-ready regulatory evidence.
Every evidence item possesses a distinct global URI, unique identifier (EV-xxxx), explicit lifecycle state, and semantic classification.
An immutable SHA-256 cryptographic fingerprint calculated over the raw dataset, execution logs, and signature block prevents any tampering.
Explicit citation to the originating source: ISO 17025 accredited laboratory, calibrated test instrument, MES batch record, or clinical database.
Strict semantic versioning with ISO 8601 UTC microsecond temporal anchoring, ensuring absolute chronological sequence in audit reconstructions.
Statistical test power (e.g., 95% confidence / 95% reliability) or algorithmic attestation score measuring evidential completeness.
FDA 21 CFR Part 11 compliant electronic signature recording reviewer identity, organizational role, approval timestamp, and public key cert.
Continuous graph edges directly linking the evidence to user needs, design inputs, risk controls, firmware commits, and regulatory filings.
Append-only revision history preventing silent deletion or retroactive modification, satisfying FDA and EU MDR auditor scrutiny.
Select an evidence record to inspect its raw cryptographic metadata, 21 CFR Part 11 signature block, connected graph objects, and verify its SHA-256 hash in real time.
Change CHG-1024 was initiated for CardioSense Pro v3.8.2 to substitute temperature transducer S-18 with S-22 due to Supplier Y lead-time constraints. Additionally, an IEC 60601-1-11 thermal limit amendment was mapped to requirement REQ-0184.