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System Architecture
Overview
BioWise is built as a modular, microservices-oriented platform designed for pharmaceutical compliance orchestration. The architecture prioritizes data integrity, auditability, and seamless integration with existing enterprise systems.
Core Design Principles
- Ontology-First: All data modeled as typed objects with enforced relationships
- Audit Everything: Every action logged with user, timestamp, and reason
- Connector-Based: Source systems remain authoritative; we orchestrate
- AI-Augmented: Human-in-the-loop with AI suggestions, not replacements
Technology Stack
| Layer | Technology | Purpose |
|---|---|---|
| API | FastAPI (Python) | REST/GraphQL endpoints, async processing |
| Frontend | React + TypeScript | Interactive UI, real-time updates |
| Database | PostgreSQL | Entity storage, full-text search |
| Graph | Neo4j | Relationship traversal, lineage |
| Embeddings | pgvector | Semantic search, similarity |
| Storage | AWS S3 | Documents, versioning enabled |
| Queue | Redis / Celery | Async jobs, agent tasks |
| AI | Anthropic Claude | Document processing, NL queries |
Ontology Model
The ontology defines object types and their relationships. Core entity types include:
- Product: Finished goods with BOM linkages
- Component: Raw materials, intermediates, packaging
- Supplier: Qualified vendors with status tracking
- Certificate: CoA, CoC, qualification documents
- Batch: Production lots with material linkages
- QualityEvent: Deviations, CAPAs, complaints
Data Flow
- Ingest: Documents uploaded or pulled from connectors
- Extract: AI agents extract structured data
- Link: Entities linked via ontology relationships
- Index: Content indexed for search (FTS + semantic)
- Sync: Changes propagated to source systems (optional)
Security Model
Security follows zero-trust principles with identity-aware access:
- JWT-based authentication with refresh tokens
- Role-based access control (RBAC) with fine-grained permissions
- Per-entity access policies (owner, department, classification)
- Supplier portal isolation (multi-tenant views)
- All actions logged to immutable audit trail