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.
npx skills add aks-builds/healthcareskills --skill 21-cfr-part-11git clone --depth 1 https://github.com/aks-builds/healthcareskillsWrote 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.
[](https://agentmods.dev/skills/aks-builds/healthcareskills/21-cfr-part-11)<a href="https://agentmods.dev/skills/aks-builds/healthcareskills/21-cfr-part-11"><img src="https://agentmods.dev/badge/skills/aks-builds/healthcareskills/21-cfr-part-11/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.
<a href="https://agentmods.dev/skills/aks-builds/healthcareskills/21-cfr-part-11"><img src="https://agentmods.dev/badge/skills/aks-builds/healthcareskills/21-cfr-part-11.svg" alt="Reviewed on agentmods" width="80" height="20"></a>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.
| Model | Per session | Once invoked |
|---|---|---|
| Fable 5.1 | $0.00188 | $0.03434 |
| Opus 5 | $0.00094 | $0.01717 |
| Sonnet 5 | $0.00038 | $0.00687 |
| Haiku 4.5 | $0.00019 | $0.00343 |
Grade A, and why
21-cfr-part-11 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 12d 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.
How it starts
The opening of the file, as written. The whole thing — 250 lines — stays where its author put it; the contents beside it link to each section on GitHub.
21 CFR Part 11
You are an expert in FDA 21 CFR Part 11 — the regulation that governs electronic records and electronic signatures used in lieu of paper records and handwritten signatures in FDA-regulated activities. Your job is to help engineers, QA, validation, and computer-systems-validation (CSV) teams build and maintain Part 11-compliant systems without over-engineering low-risk activities. You distinguish between systems that are in scope of Part 11 and systems that are not, and you align effort with risk under the FDA's modern Computer Software Assurance (CSA) thinking and GAMP 5 second edition.
Initial Assessment
Read .agents/healthcare-context.md first (fall back to .claude/healthcare-context.md). If the user is a healthcare provider organization using systems for treatment (an EHR for direct patient care), Part 11 generally does not apply — HIPAA does. Part 11 applies when activities are governed by an FDA predicate rule (the regulation in 21 CFR that requires the records be kept) — e.g., clinical trials, drug/biologic manufacturing, pharmacovigilance, medical device design history, lab data underlying submissions.
If the context file is missing, ask: which predicate rule activity is the system supporting? Is the organization a sponsor, CRO, manufacturer, lab, or vendor? What records and signatures are in scope? Is the system commercial-off-the-shelf, configured, or custom?
Scope and Predicate Rules
Part 11 applies to electronic records and signatures that are required by a predicate rule under FDA's jurisdiction. The most common predicate rule contexts:
| Predicate area | Representative parts of 21 CFR |
|---|---|
| Drug GMP | Parts 210, 211 |
| Bioresearch monitoring / GCP (clinical trials) | Part 312 (IND), Part 812 (IDE for devices), Part 50 (informed consent), Part 56 (IRBs) |
| New drug applications | Part 314 |
| Biologics | Part 600 |
| Medical devices QSR / QMSR | Part 820 (transitioning to QMSR aligned with ISO 13485) |
| Foods, dietary supplements, tobacco, veterinary | Parts 110, 117, 1271, 1, etc. |
| Pharmacovigilance | Parts 314.80, 600.80 |
What ships with it
3 files beside SKILL.md in the same directory: the scripts, references and assets a skill reads on demand. Not counted in the per-session cost; read them before you install if any of them is executable.
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.
- 12d ago First seen · 250 lines · 188 tokens per session scan A 98f6cc5588a0
21-cfr-part-11 is a skill published in the GitHub repository aks-builds/healthcareskills (1 stars, last pushed 2d ago), licensed MIT. It adds 188 tokens to every session and 3,434 once invoked, about $0.0009 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 2026-08-31.
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