Legal & Compliance
Auditing Part11 Trails
Generates and verifies 21 CFR Part 11-style audit trails — who/what/when, electronic signatures, and tamper-evidence — for OpenMed pipelines in GxP and clinical-trial (GCP) settings. Use when the user runs OpenMed in a regulated/validated environment and needs an attributable, time-stamped, tamper-evident record of each processing action, electronic-signature manifestations, or computer-system-validation (CSV) evidence. Trigger keywords: 21 CFR Part 11, Part 11, audit trail, electronic signature, e-signature, GxP, GCP, GLP, GMP, CSV, computer system validation, data integrity, ALCOA, tamper-evident, contemporaneous. Pairs adjacent to OpenMed: maps directly onto OpenMed deidentify(audit=True) -> signed AuditReport with .sign(key)/.verify(key), whose repro_hash + HMAC give the tamper-evidence and attribution Part 11 expects. This is a compliance-enablement aid, not a validation certification.
- Publisher / source
- maziyarpanahi/openmed (found on GitHub top repositories)
- Upstream record
- maziyarpanahi/openmed
- Version
- Version 1
- Published
- Publication review
- Approved for publication
- Content fingerprint
4f8a4287c9b8889f0b56b4f5d9cd0c6e0fa8a3e0974a05b4e3a487202f1c0a99