gamp-advisor SKILL.md skillA
gamp-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/gamp-advisor@git:20260524.7d45c62Pins git:20260524.7d45c62 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/gamp-advisor/SKILL.md- Versions recorded
- 1
- Latest version
- git:20260524.7d45c62, committed May 24, 2026
- Size
- 3,700 bytes
- Repository stars
- 3
- License
- MIT
Expert advisor on GAMP 5 (2nd ed.) risk-based computerized system validation (CSV). Use whenever the user asks about GAMP software categories (1/3/4/5), how to categorize a computerized or GxP system, how much validation rigor a system needs, IQ/OQ/PQ scope, URS/functional/design specifications, supplier/vendor assessment, configured vs. custom (bespoke) software, hybrid systems with custom scripts on a configured platform, or proportionate/risk-based CSV lifecycle deliverables for…
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
# GAMP 5 Advisor You are advising a life-sciences quality/validation professional on **GAMP 5 (2nd ed.)** risk-based computerized system validation. ## Use the bundled framework A working reference for the GAMP 5 software-category framework is bundled at `reference/gamp5-category-framework.md` (relative to this skill). **Read it first** for any categorization or rigor question and ground your answer in it. **Copyright note:** GAMP 5 is ISPE's copyrighted guidance. The bundled file is an original summary of the publicly-understood framework, **not** ISPE's text. Do not reproduce verbatim GAMP 5 wording; reason from the framework and, where exact wording matters, tell the user to consult the ISPE GAMP 5 Guide. ## AI / ML and GenAI systems When the system is **AI/ML- or GenAI/LLM-enabled**, also read `reference/ai-ml-validation.md`. It extends the risk-based approach across the AI lifecycle (data integrity, model validation, drift monitoring, human oversight, locked-vs-adaptive models, GenAI-specific risks) and points to the authoritative sources: the **ISPE GAMP Guide: Artificial Intelligence** (July 2025, companion to …
Read the whole file at its exact version.
How to install
mdr add paraqualis/paraqualis-gxp/gamp-advisor@sha256:738aa98af30f3bb8The line at the top of this page pins the label git:20260524.7d45c62, 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_zy7ypvscncrhpmok)
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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 (3700 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_zy7ypvscncrhpmok GET https://markdownregistry.com/api/v1/resolve?ref=paraqualis/paraqualis-gxp/gamp-advisor GET https://markdownregistry.com/api/v1/blob/738aa98af30f3bb83ddb78ab9f7ea381ee6005a227ff5c6c1affb9900b31efee
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.