part11-advisor skillA
part11-advisor is agent-read markdown (skill) from paraqualis/paraqualis-gxp: Expert advisor on FDA 21 CFR Part 11 (electronic records and electronic signatures). Use whenever the user asks about Part 11 compliance, electronic records or signatures, audit trails, closed vs. open systems, e-signature components/controls, record retention or copies for the agency, ALCOA+ data integrity under Part 11, a Part 11 gap or inspection readiness, or whether a computerized/GxP system meets §11.10, §11.30, §11.50, §11.70, §11.100, §11.200, or §11.300. Reasons against the bundled verb.
Indexed from public GitHub and served as immutable, content-addressed versions. Install it pinned to an exact SHA-256 with the mdr CLI, and every file is verified against the hash recorded here before it reaches your agent. The deterministic audit below grades the latest version, and the same file always earns the same grade.
What the file says
# 21 CFR Part 11 Advisor You are advising a life-sciences quality/validation professional on **21 CFR Part 11**. ## Use the bundled regulation text — don't rely on memory The **verbatim text of all of Part 11** is bundled at `reference/21-cfr-part-11.md` (relative to this skill). For any substantive question, **read that file first** and ground your answer in it. Quote the exact wording and cite the precise paragraph (e.g. `§ 11.10(e)` for audit trails), so the advice is auditable. The bundled text is a snapshot of the eCFR edition captured Jan 2026. If the user needs to confirm current wording or recent amendments, point them to the `/eCFR:text`, `/eCFR:changes`, or `/eCFR:compare` commands rather than assuming the snapshot is the latest. ## How to advise 1. **Lead with the answer** — the compliance verdict or recommendation first, in a line. 2. **Cite the controlling paragraph** — tie every assertion to a specific §/paragraph from the bundled text. Distinguish §11.10 *closed-system* controls from §11.30 *open-system* controls based on who controls system access. 3. **Be proportionate to risk** — scale rigor to the system's GxP impact; don't demand …
Read the whole file at its exact version.
How to install
mdr add paraqualis/paraqualis-gxp/part11-advisor@git:20260524.650b4fdmdr add paraqualis/paraqualis-gxp/part11-advisor@sha256:a814e0914371a0f9Pin to a label to follow the author's releases, or to a sha256 to freeze the exact bytes forever. Either way the resolved hash is written to mdr.lock, and mdr install reproduces it on any machine.
[](https://markdownregistry.com/a/art_33pzolkmdggjiaua)
1 badge views in 30 days
Versions
Audit of the latest version
- pass: Frontmatter block present
- pass: Frontmatter declares a name
- pass: Frontmatter declares a description
- pass: Size between 200 bytes and 200 KB (2761 bytes)
- pass: No zero-width or bidi control characters
- pass: No instruction hidden inside an HTML comment
- pass: No link to an exfiltration or paste host
- pass: No credential-shaped string
- pass: No instruction to send local credentials anywhere
- pass: No text hidden with inline styles
- pass: No prompt-injection phrasing
- pass: No curl or wget piped into a shell
- pass: No recursive delete of root, home or parent
- pass: No instruction to read or print local credentials
- pass: No base64 blob over 200 characters
- pass: No link to a raw IP address
- pass: No script tag
Source
paraqualis/paraqualis-gxp · 3 stars · license MIT · pushed 2026-09-24 · branch main
API
GET https://markdownregistry.com/api/v1/artifacts/art_33pzolkmdggjiaua GET https://markdownregistry.com/api/v1/resolve?ref=paraqualis/paraqualis-gxp/part11-advisor GET https://markdownregistry.com/api/v1/blob/a814e0914371a0f9d0f8666110fa5a6e11f907d16e646714fb3d42a2292162c1
Your agent does the legwork. You hear about the deals worth your word. Hand yours the standing instructions at modelranch.com and it joins the network that reads files like this one.