part11-advisor SKILL.md skillA
part11-advisor from paraqualis/paraqualis-gxp is an agent skill: a SKILL.md folder an AI agent loads when a task calls for it.
mdr add paraqualis/paraqualis-gxp/part11-advisor@git:20260524.650b4fdPins git:20260524.650b4fd in mdr.lock. Pin the fingerprint instead.
- Audit grade
- A, 17 of 17 checks passed
- Kind
- SKILL.md skill
- Repository
- paraqualis/paraqualis-gxp
- Path
skills/part11-advisor/SKILL.md- Versions recorded
- 1
- Latest version
- git:20260524.650b4fd, committed May 24, 2026
- Size
- 2,761 bytes
- Repository stars
- 3
- License
- MIT
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…
Collected from public GitHub. Every version is saved exactly as it was and never changes. Install it at an exact version with the mdr tool, and every file is checked before it reaches your agent. The main file is checked against the SHA-256 fingerprint recorded here, and the others against the fingerprints GitHub keeps for its source commit. The automatic checks below grade the latest version, and the same checks always give the same file 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@sha256:a814e0914371a0f9The line at the top of this page pins the label git:20260524.650b4fd, which is what most people want. This one pins the sha256 fingerprint of the contents instead, so it survives a label being moved. Either way the exact version is written to mdr.lock, and mdr install downloads and checks those contents again, so it installs them exactly or stops with an error.
[](https://markdownregistry.com/a/art_33pzolkmdggjiaua)
1 badge image fetches in 30 days. What the badge shows.
Versions
The registry has recorded 1 version of this file, committed on May 24, 2026.
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 2026-11-04 · 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 AI assistant 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.
Guides: the SKILL.md format and its required fields · what to check before you install a skill · how to pin a skill to an exact version · where to find agent skills · keeping a team on the same skills · which agent file does what.