paraqualis
OrganizationLife-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.
Categories
Indexed Skills (2)
gamp-advisor
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-advisor
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.
Bio shown is the top-scored skill's repo description as a fallback — real GitHub bios land in a future update.