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-ev
npx skills add maziyarpanahi/openmed --skill auditing-part11-trails --agent claude-code
Same command for any agent — swap --agent for codex, cursor, copilot.
Weekly change comes from our own snapshots, not the repository page — it measures attention, not adoption.
# Auditing 21 CFR Part 11 trails for OpenMed pipelines In FDA-regulated **GxP** work (GCP clinical trials, GLP, GMP) any electronic record used to support a regulatory decision must meet **21 CFR Part 11**: it has to be **attributable** (who), **contemporaneous and time-stamped** (when), describe **what** changed, be **tamper-evident**, and — where a signing event occurs — carry a controlled **electronic signature**. These map onto the **ALCOA+** data-integrity expectations (Attributable, Legible, Contemporaneous, Original, Accurate, +Complete/Consistent/Enduring/Available). OpenMed's `deidentify(..., audit=True)` already emits a deterministic, **PHI-free `AuditReport`** that you can `.sign()` (HMAC-SHA256) and later `.verify()`. That gives you the *tamper-evidence* and *attribution* primitives; this skill wraps them in the who/when/what/e-signature envelope Part 11 wants. This is a **compliance-enablement aid**. Part 11 compliance also requires validated systems (CSV), SOPs, and access controls that live outside any single library — a QA/validation lead signs off. ## When to use - OpenMed runs inside a validated/GxP environment and each run must leave an attributable, tamper-evide
- When to use
- How OpenMed's AuditReport maps to Part 11
- Quick start
- Workflow
- Hand-off to / from OpenMed
- Edge cases & gotchas
- Standards & references
What does the auditing-part11-trails skill do?
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-ev
How do I install it?
Run `npx skills add maziyarpanahi/openmed --skill auditing-part11-trails --agent claude-code` — it drops the skill into your project so the agent can pick it up. Swap the --agent value for codex, cursor or copilot if you use one of those.
Where does this skill come from?
From maziyarpanahi/openmed, a repository with 4,851 stars. We read it straight from the repository tree rather than a submitted listing, so what you see here is what is actually published.
Is a popular skill a good skill?
Not necessarily. Stars measure attention, not adoption — a repository can trend for a week and be abandoned. That is why we show the weekly change from our own snapshots next to the total, instead of a single flattering number.