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Documentation
Technical guides, architecture details, and integration documentation.
Architecture
System design, ontology model, and data flow
Integrations
Veeva, SAP, TrackWise connectors
API Reference
REST API endpoints and schemas
Architecture Overview
┌─────────────────────────────────────────────────────────────────┐ │ BIOWISE PLATFORM │ ├─────────────────────────────────────────────────────────────────┤ │ ┌─────────────┐ ┌─────────────┐ ┌─────────────┐ │ │ │ Web UI │ │ REST API │ │ GraphQL │ Clients │ │ └──────┬──────┘ └──────┬──────┘ └──────┬──────┘ │ ├─────────┴────────────────┴────────────────┴─────────────────────┤ │ API GATEWAY (FastAPI) │ ├─────────────────────────────────────────────────────────────────┤ │ ┌─────────────────────────────────────────────────────────┐ │ │ │ ONTOLOGY LAYER │ │ │ │ ┌─────────┐ ┌─────────┐ ┌─────────┐ ┌─────────┐ │ │ │ │ │ Product │──│Component│──│Supplier │──│ Cert │ │ │ │ │ └─────────┘ └─────────┘ └─────────┘ └─────────┘ │ │ │ └─────────────────────────────────────────────────────────┘ │ ├─────────────────────────────────────────────────────────────────┤ │ ┌───────────────────┐ ┌───────────────────┐ │ │ │ AI AGENTS │ │ WORKFLOW ENGINE │ │ │ │ • Certificate │ │ • State Machine │ │ │ │ • Impact │ │ • Approvals │ │ │ │ • Expiry │ │ • E-Signatures │ │ │ │ • Query │ │ • Audit Trail │ │ │ └───────────────────┘ └───────────────────┘ │ ├─────────────────────────────────────────────────────────────────┤ │ ┌─────────────────────────────────────────────────────────┐ │ │ │ CONNECTORS │ │ │ │ ┌──────┐ ┌──────┐ ┌──────────┐ ┌──────┐ ┌──────┐ │ │ │ │ │Veeva │ │ SAP │ │TrackWise │ │ LIMS │ │Custom│ │ │ │ │ └──────┘ └──────┘ └──────────┘ └──────┘ └──────┘ │ │ │ └─────────────────────────────────────────────────────────┘ │ ├─────────────────────────────────────────────────────────────────┤ │ ┌──────────────┐ ┌──────────────┐ ┌──────────────┐ │ │ │ PostgreSQL │ │ Neo4j │ │ AWS S3 │ Storage │ │ │ (entities) │ │ (graph) │ │ (documents) │ │ │ └──────────────┘ └──────────────┘ └──────────────┘ │ └─────────────────────────────────────────────────────────────────┘
Core Components
- Ontology Layer: Semantic data model with enforced relationships
- AI Agents: LLM-powered automation for compliance tasks
- Workflow Engine: State machine with e-signature support
- Connectors: Bi-directional sync with source systems
Data Storage
- PostgreSQL: Entities, metadata, audit logs
- Neo4j: Graph relationships, lineage, traversal
- AWS S3: Document storage with versioning
- pgvector: Embeddings for semantic search
System Integrations
Veeva Vault
- • QMS, QualityDocs, Training modules
- • Document sync via Vault API
- • Metadata extraction and linking
- • Bi-directional object references
SAP QM
- • Material master, batch data
- • Quality inspection results
- • Vendor qualifications
- • RFC/BAPI integration
TrackWise / Sparta
- • Deviations, CAPAs, Complaints
- • Quality event linking
- • Change control records
- • Web services API
Additional Systems
- • Documentum (legacy document management)
- • Loftware (labeling systems)
- • LIMS (laboratory data)
- • Custom connectors available
AI Agent Capabilities
Certificate Intake Agent
Automatically processes incoming Certificates of Analysis (CoA) and Conformity (CoC).
- • PDF parsing with vision model
- • Supplier identification
- • Spec extraction (expiry, batch, results)
- • Auto-linking to materials
Change Impact Agent
Analyzes proposed changes and identifies affected entities across the ontology.
- • Graph traversal for impact analysis
- • Regulatory assessment
- • Affected product identification
- • Risk scoring
CAPA Intelligence Agent
Assists with root cause analysis and corrective action recommendations.
- • Historical deviation analysis
- • Root cause hypotheses
- • Similar incident matching
- • Action effectiveness tracking
Compliance & Validation
21 CFR Part 11 Compliance
- ✓ Electronic signatures with meaning
- ✓ Complete audit trails (who, what, when, why)
- ✓ System access controls
- ✓ Data integrity validation
- ✓ Record retention and retrieval
GAMP 5 Validation
- ✓ Category 4 (Configured Product)
- ✓ Risk-based validation approach
- ✓ IQ/OQ/PQ documentation
- ✓ Traceability matrix
- ✓ Change control procedures