paraqualis-gxp

v1.2.1

Life-sciences regulatory & computer-system-validation toolkit for Claude Code — GAMP 5, 21 CFR Part 11, EU GMP Annex 11, the live eCFR, openFDA, and an IQ/OQ/PQ qualification engine (/qualify:build, /qualify:requirements, /qualify:review). Commands, skills, sub-agents, and a document-protection hook. Run /openfda:setup once to provision a free personal openFDA API key (one minute, raises rate limits ~1,000 → ~120,000 requests/day).

Claude Code2 Skills1 MCP serverstdio

By ParaQualis LLCLicense: MIT2 GitHub starsUpdated 3 days ago

Directory evidence

Runtimes: Claude Code
Parsed components: 3 skill or MCP entries
Source updated: Sep 20, 2026
Manifest status: Canonical path parsed

The directory validates manifest shape and source location. It does not execute the plugin or provide a security endorsement. Review the indexing methodology →

Install paraqualis-gxp for Claude Code

Installs for the current user

claude plugin marketplace add IchenDEV/agent-plugin-mkt
claude plugin marketplace update agent-plugin-marketplace
claude plugin install paraqualis-gxp@agent-plugin-marketplace

Paste and run these commands in a terminal with Claude Code. They add and refresh the PluginsMP catalog, then install this plugin.

The installer fetches third-party code from the source repository shown on this page. This directory validates manifest structure and source location, but does not perform a security audit; review the manifest, components, and source before installing.

Get the source manually

$ git clone https://github.com/paraqualis/paraqualis-gxp

Clone the source repository, then follow its setup instructions to add the plugin to a compatible client. The repository root is the plugin root.

Plugin files

paraqualis-gxp/

├── .claude-plugin/plugin.json
├── skills/gamp-advisor/SKILL.md
├── skills/part11-advisor/SKILL.md
└── .mcp.json

Included Skills2

gamp-advisorskills/gamp-advisor/SKILL.md

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/medtech systems. Also covers validation of AI/ML- and GenAI/LLM-enabled GxP systems (model validation, training-data integrity, drift monitoring, human oversight) per the ISPE GAMP Guide: Artificial Intelligence. Reasons against the bundled GAMP 5 category framework and AI/ML reference.

part11-advisorskills/part11-advisor/SKILL.md

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 verbatim regulation text and cites the exact paragraph.

MCP servers1

openfdastdio

command: python3
args: ${CLAUDE_PLUGIN_ROOT}/mcp-servers/openfda/server.py

MCP configuration uses runtime-provided plugin path placeholders such as ${PLUGIN_ROOT} or ${CLAUDE_PLUGIN_ROOT}. Review the manifest for the runtime-specific expansion rules.

Plugin manifests1

.claude-plugin/plugin.json

{
  "name": "paraqualis-gxp",
  "version": "1.2.1",
  "description": "Life-sciences regulatory & computer-system-validation toolkit for Claude Code — GAMP 5, 21 CFR Part 11, EU GMP Annex 11, the live eCFR, openFDA, and an IQ/OQ/PQ qualification engine (/qualify:build, /qualify:requirements, /qualify:review). Commands, skills, sub-agents, and a document-protection hook. Run /openfda:setup once to provision a free personal openFDA API key (one minute, raises rate limits ~1,000 → ~120,000 requests/day).",
  "author": {
    "name": "ParaQualis LLC",
    "url": "https://github.com/paraqualis/paraqualis-gxp"
  },
  "homepage": "https://github.com/paraqualis/paraqualis-gxp",
  "repository": "https://github.com/paraqualis/paraqualis-gxp",
  "license": "MIT",
  "keywords": [
    "gamp",
    "gamp5",
    "21-cfr-part-11",
    "annex-11",
    "csv",
    "computer-system-validation",
    "ecfr",
    "openfda",
    "qualification",
    "iq-oq-pq",
    "life-sciences",
    "pharma",
    "regulatory",
    "gxp"
  ],
  "mcpServers": {
    "openfda": {
      "command": "python3",
      "args": [
        "${CLAUDE_PLUGIN_ROOT}/mcp-servers/openfda/server.py"
      ]
    }
  }
}

For maintainers

If you maintain this plugin, link to this source-backed listing from your README so users can review its manifest and indexed components.

[paraqualis-gxp on Agent Plugins Marketplace](https://pluginsmp.com/plugins/paraqualis-gxp)