auditing-part11-trails

auditing-part11-trails is a skill for Claude Code from maziyarpanahi/openmed. It costs 222 tokens per session (2,305 once invoked), scanned A, original, Apache-2.0.

A tool for creating and checking audit records for OpenMed workflows in regulated medical and clinical research. These records show who did what and when, and can include electronic signatures and tamper-evidence.

In plain words
What is it for?
Adding attributable, time-stamped, change-focused audit trails to OpenMed pipelines used in clinical trials, manufacturing, laboratory, or other regulated settings.
Why use it?
Regulated work needs trustworthy records proving how data was handled and changed. This helps organize those records, but does not replace broader validation procedures, operating rules, or access controls.

Skill for Claude Code

Written for Claude Code: shipped in a Claude Code plugin.

Part of the openmed-skills plugin — 74 skills shipped together

Good fit Adding attributable, time-stamped, change-focused audit trails to OpenMed pipelines used in clinical trials, manufacturing, laboratory, or other regulated settings.

Compare 6 skills from other repositories ↓
Install with agentmods
npx agentmods add skills/maziyarpanahi/openmed/auditing-part11-trails
About the project

OpenMed is local-first healthcare AI software that extracts clinical information and removes personally identifying details from clinical text on hardware controlled by the user. Healthcare developers use its Python runtime, Apple Silicon and mobile SDKs, and browser support for on-device clinical NER and PII de-identification.

maziyarpanahi/openmed · 5,290 stars · on GitHub · openmed.life

Install

Getting it into your agent

One page per mod, every tool's command on it. A separate URL per tool would split the same page into five that compete with each other.

Any agent
npx skills add maziyarpanahi/openmed --skill auditing-part11-trails
Clone the repo
git clone --depth 1 https://github.com/maziyarpanahi/openmed

Made for: Claude Code.

Or install openmed-skills, the plugin that ships this one along with the rest of its 74 skills.

Wrote this? Show the measurements

A badge with what this costs and how it scanned, read live from this page, so it follows the numbers instead of freezing them. Markdown for a README, HTML for a documentation site or a project page.

agentmods badge for auditing-part11-trails

README.md
[![agentmods](https://agentmods.dev/badge/skills/maziyarpanahi/openmed/auditing-part11-trails/github.svg)](https://agentmods.dev/skills/maziyarpanahi/openmed/auditing-part11-trails)
Your own site
<a href="https://agentmods.dev/skills/maziyarpanahi/openmed/auditing-part11-trails"><img src="https://agentmods.dev/badge/skills/maziyarpanahi/openmed/auditing-part11-trails/github.svg" alt="Measured on agentmods" height="20"></a>

Or the 80×15 button, for a site that already has a row of RSS and ATOM ones. Only the verdict fits; the numbers stay here.

agentmods 80×15 button for auditing-part11-trails

Your own site · 80×15
<a href="https://agentmods.dev/skills/maziyarpanahi/openmed/auditing-part11-trails"><img src="https://agentmods.dev/badge/skills/maziyarpanahi/openmed/auditing-part11-trails.svg" alt="Reviewed on agentmods" width="80" height="20"></a>
Per session 222 Skills are progressive disclosure: only the name and description are preloaded; the body loads when the skill is used.
When invoked 2,305 The whole file, excluding the scripts and references it only reads on demand.
Security scan A 0 findings. A grade says what 26 rules found in the file — not that it is safe. Third-party audits
  • NVIDIA SkillSpector pass 7 Sept 2026
How audits are shown
Origin original No closer match found in the catalogue.
Token cost

What it costs to keep this loaded

Counted locally with the o200k_base tokenizer, which is exact for GPT models; Claude uses its own tokenizer and its counts differ. Treat this as one consistent yardstick across the catalogue rather than a bill. Prices are per million input tokens.

ModelPer sessionOnce invoked
Fable 5.1 $0.00222 $0.02305
Opus 5 $0.00111 $0.01153
Sonnet 5 $0.00044 $0.00461
Haiku 4.5 $0.00022 $0.00231

Measured 11d ago against content hash 4f8a4287c9b8, method: parsed. Prices are Anthropic first-party input rates as of 2026-09-11, from the pricing page.

Security

Grade A, and why

auditing-part11-trails scanned grade A with 0 findings against 26 rules in 11 categories — prompt injection, anti-refusal, data exfiltration, privilege escalation, supply chain, agent snooping, system-prompt leakage, SSRF and excessive agency — measured 11d ago.

A static scan of the body, not an audit. Every finding is printed with the line that produced it so you can judge whether it matters here. A mod is markdown that instructs an agent; that is exactly why what it instructs is worth reading.

Nothing flagged

None of the 26 patterns this scan looks for appear in this file: no shell pipes, no recursive deletes, no credential paths, no hidden text, no instruction-override or anti-refusal phrasing, no agent-config snooping. That is not a guarantee, it is the absence of the things that are checkable.

skills/auditing-part11-trails/SKILL.md · 147 lines

How it starts

The opening of the file, as written. The whole thing — 147 lines — stays where its author put it; the contents beside it link to each section on GitHub.

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-evident record.
  • You need to wrap an OpenMed AuditReport with who/when/what + an e-signature manifestation (meaning, signer, timestamp).
  • You must verify a stored trail hasn't been altered, or produce CSV evidence for an inspection.

How OpenMed's AuditReport maps to Part 11

Part 11 expectation 21 CFR cite OpenMed mechanism
Tamper-evident, accurate copies 11.10(b),(c) AuditReport.to_json() + repro_hash over the canonical payload
Audit trail: what changed, when 11.10(e) AuditReport.spans (action per identifier), input_hash/deidentified_text_hash, openmed_version, manifest_hash
Operational/authority checks; attribution 11.10(d),(g) AuditSignature.key_id (signer/key identity) + your envelope's user id
Signature manifestation (name, date, meaning) 11.50 Your envelope fields signer, signed_at, meaning
Signature/record linking, non-repudiation 11.70, 11.200 HMAC-SHA256 over the canonical payload via .sign() / .verify()

Read the full file on GitHub · 147 lines

Changes

What this file has done since we first saw it

Hashed on every crawl. A supply-chain change to an agent config is a question of when, not whether, so the history is kept rather than the latest state alone.

  1. 11d ago First seen · 147 lines · 222 tokens per session scan A 4f8a4287c9b8

Subscribe to this mod's changes

auditing-part11-trails is a skill published in the GitHub repository maziyarpanahi/openmed (5,290 stars, last pushed today), licensed Apache-2.0. It adds 222 tokens to every session and 2,305 once invoked, about $0.0011 per session on Opus 5. A static security scan graded it A with 0 findings. No closer match exists in the catalogue, so it is treated as the original; first seen 2026-08-30.

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