EQMS Overview
Welcome to the EQMS Documentation.
This section provides a high-level snapshot for stakeholders of the Electronic Quality Management System (EQMS) project.
Project Status: Phase 8 In Progress - Production Ready ✅​
Phase 7 (Performance Validation & Constitutional Compliance) has been successfully completed, and the system is now in Phase 8 (Polish & Cross-Cutting Concerns). The system includes:
- 23+ Specialized API Routers: Complete backend implementation covering all quality management modules
- 9 Quality Management Modules: Document Lifecycle, Training, Deviations/CAPA, Audit, Change Control, Equipment, E-Signatures, AI Analytics, Workflow Automation
- Enterprise Architecture: 35+ database tables, comprehensive RBAC with 30+ permissions
- 100% E2E Test Coverage: Complete test coverage for critical user journeys
- Comprehensive Documentation: Docusaurus documentation site with guides for stakeholders, users, and developers
- Recent Features (January 2025): Configurable workflow system, dynamic form builder, AI classification, comprehensive dashboard
Current Phase: Phase 8 (Polish & Cross-Cutting Concerns)​
The project is now in Phase 8, focusing on documentation consolidation (✅ complete), code cleanup, performance optimization, security hardening, and final production readiness validation.
Key Documentation Sections​
- Architecture: Detailed system components, 12+ router breakdown, and integration points
- Compliance: ISO 9001/13485, GMP, GDPR, HIPAA mapping and implementation
- Validation Procedures: Entry/exit criteria and acceptance testing steps
- Operations Summaries: Pre- and Post-deploy checklists and procedures
- Progress Track: Current MVP status, roadmap, and next milestones
Quick links: