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capa

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Open-source AI-powered quality management for regulated industries. React 19 + Hono + PostgreSQL + Prisma. eTMF, eConsent, batch records, design control, CAPA, deviations. 45+ models, 100+ endpoints, 18 countries, 12 languages. AGPL-3.0.

  • Updated Apr 17, 2026
  • TypeScript
dearauditor-qms-baseline

Open-source, GitHub-native eQMS baseline for medical device and regulated software teams. Issues, PRs, Actions, and Releases form the quality system of record. Covers ISO 9001, ISO 13485, ISO 14971, IEC 62304, IEC 62366-1, ISO/IEC 27001, ISO/IEC 42001, GDPR/nFADP, plus an optional GAMP 5 / 21 CFR Part 11 overlay.

  • Updated Aug 26, 2026
  • Python

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