The Platform
A semantic orchestration layer that connects your quality systems, automates compliance workflows, and provides cross-system visibility.
The challenge
Pharmaceutical companies run dozens of disconnected systems. Quality data lives in silos. Compliance requires manual effort across systems.
Certificates in one system, suppliers in another, products in a third. No single view.
Hours spent copying data between systems, checking expiries, chasing documents.
Inconsistent data across systems creates compliance gaps and audit findings.
How BioWise works
We don't replace your existing systems. We connect them into a unified layer with intelligent automation.
Semantic Ontology
A unified data model that maps objects and relationships across your entire technology stack.
- Products, suppliers, certificates linked
- Cross-system queries in real time
- Complete data lineage and traceability
AI Agents
Intelligent automation for compliance workflows, with full audit trails for every action.
- Certificate intake and validation
- Change impact analysis
- Expiry monitoring and alerts
Built for GxP
Designed from the ground up for regulated environments with validation support.
- 21 CFR Part 11 / EU GMP Annex 11
- ALCOA+ data integrity
- Complete audit trails
What you can do
Common workflows that BioWise automates across your quality systems.
Certificate Management
Receive CoA/CoC documents, extract data automatically, validate against specifications, and link to the right materials and suppliers.
Supplier Qualification
Track supplier status, monitor certificate expiries, and get alerts before qualifications lapse. See supplier impact across all products.
Change Impact Assessment
When a supplier or specification changes, instantly see all affected products, batches, and documents across every system.
Audit Readiness
Generate compliance reports that pull data from multiple systems. Answer auditor questions with linked evidence instantly.
Architecture
BioWise sits alongside your existing systems, not instead of them.
See how it works
Request a demo with your use case. We'll show you how BioWise connects to your systems.