About paraqualis/paraqualis-gxp
A complete Claude Code toolkit for computer-system validation (CSV) and life-sciences regulatory work. Covers GAMP 5 (2nd ed., including AI/ML), 21 CFR Part 11, EU GMP Annex 11, the live eCFR, and openFDA — and ships a parallel sub-agent engine (/qualify:build, /qualify:requirements, /qualify:review) that drafts a full IQ / OQ / PQ qualification pack for any application in minutes.