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computer-system-validation

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paraqualis / paraqualis-skills

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Life-sciences CSV & GxP 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. Slash commands, auto-invoked skills, parallel sub-agents, an MCP server, and a document-protection hook.

csv validation mcp qualification gamp pharma life-sciences regulatory openfda gxp gamp5 mcp-server claude-code ecfr computer-system-validation 21-cfr-part-11 claude-code-plugin claude-plugin iq-oq-pq eu-annex-11
  • Updated Jun 19, 2026
  • Python

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