gamp-advisor skillA
gamp-advisor is agent-read markdown (skill) from paraqualis/paraqualis-gxp: 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 pharma/medtec.
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
# 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@git:20260524.7d45c62mdr add paraqualis/paraqualis-gxp/gamp-advisor@sha256:738aa98af30f3bb8Pin 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_zy7ypvscncrhpmok)
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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 (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 2026-09-24 · 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
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