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Claude Skills by paraqualis

github.com/paraqualis

2 skillsA× 20 installs1 views

Gamp AdvisorAExpert 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/med...ai-agentsgoVotes: 0GitHub stars: 3
Part11 AdvisorAExpert 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 v...ai-agentsgorailsVotes: 0GitHub stars: 3

Claude Skills by paraqualis — 2 skills, security-graded | Skills Directory