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auditing-part11-trails

Create and verify HMAC-signed audit trail envelopes for OpenMed processing.

5.0k|615|Updated Oct 4, 2025
Search Tags:#data integrity#audit trail#electronic signatures#21 cfr part 11#hmac verification#gxp compliance#computer system validation
One-click install
npx skills add https://github.com/maziyarpanahi/openmed --skill auditing-part11-trails
Or copy as Structured Prompt for Agent▼
Please help me install this Agent Skill.
Skill: auditing-part11-trails
Source: https://github.com/maziyarpanahi/openmed/tree/main/skills/auditing-part11-trails
Command: npx skills add https://github.com/maziyarpanahi/openmed --skill auditing-part11-trails

SYSTEM DOCUMENTATION & REQUIREMENTS

What problem does it solve?

This Skill helps regulated clinical and GxP teams create attributable, time-stamped, tamper-evident records for OpenMed processing activities without overstating that the library alone provides full 21 CFR Part 11 compliance.

Core Features & Use Cases

  • Audit Trail Envelopes: Wrap OpenMed AuditReport records with who, when, what, system, and electronic-signature manifestation fields.
  • Integrity Verification: Sign and verify audit reports with HMAC-SHA256, reproducibility hashes, and optional source or output text binding.
  • Regulated Workflows: Support GCP, GLP, GMP, CSV, ALCOA+, inspection evidence, append-only retention, controlled key management, and PHI-free audit records.

Quick Start

Use the auditing-part11-trails skill to create and verify a signed, PHI-free 21 CFR Part 11 audit envelope for an OpenMed de-identification run.

Frequently Asked Questions about auditing-part11-trails

High-intent search queries and answers about installing and using this skill.

FAQPage Schema
How do I create tamper-evident audit trails for 21 CFR Part 11 compliance?▼

Tamper-evident 21 CFR Part 11 audit trails are created by wrapping processing records with who, when, what, and system fields, then securing them with HMAC-SHA256 signatures and append-only retention controls.

Do I need controlled key management for GxP compliance audit trails?▼

Controlled key management is required for GxP compliance to generate valid electronic signatures and cryptographic proofs, ensuring audit records remain attributable and secure throughout regulated workflows.

Can I generate PHI-free audit records for clinical text processing?▼

PHI-free audit records for clinical text processing are generated by creating audit envelopes that bind system metadata and reproducibility hashes without exposing protected health information.

What is needed to support electronic signatures in computer system validation?▼

Supporting electronic signatures in computer system validation requires authenticated user identity, controlled HMAC key management, and signature manifestation fields embedded within the audit trail envelope.

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