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quality-management

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快格云制造MES 是一个功能完整的制造执行系统(Manufacturing Execution System),专为生产型企业数字化转型设计。基于RiverEdge框架,使用现代化的技术栈(FastAPI + React),提供生产计划、工单管理、质量追溯、设备监控等核心功能。亦兼具ERP基础功能,未来规划CRM、AI、极简APS模块。

  • Updated Sep 1, 2026
  • TypeScript

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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