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.
csvvalidationmcpqualificationgamppharmalife-sciencesregulatoryopenfdagxpgamp5mcp-serverclaude-codeecfrcomputer-system-validation21-cfr-part-11claude-code-pluginclaude-pluginiq-oq-pqeu-annex-11
-
Updated
Aug 13, 2026 - Python