Pharmaceutical
Compliance Intelligence
An ontology-based orchestration layer that unifies legacy pharma compliance systems — SAP, Veeva, Documentum — without replacing them. Built in collaboration with BioVice by the Composable Collective founding team.
The Challenge
Legacy systems that can’t be replaced — and can’t communicate.
Pharmaceutical manufacturers operate critical compliance systems that are 25–30 years old and completely irreplaceable. Documentum, Veeva, SAP, TrackWise — these systems are deeply validated, deeply embedded, and deeply siloed. They cannot talk to each other.
Quality teams spend enormous time manually reconciling data across platforms that were never designed to work together. Certificate management, change control, CAPA tracking — all managed in separate systems with no cross-system visibility.
Replacing these systems is not an option. Revalidation costs alone run into tens of millions. The question was: how do you build intelligence on top of systems you can’t change?
Our Approach
A semantic layer that wraps — not replaces.
We built an ontology-based data orchestration layer inspired by Palantir Foundry’s architecture. Instead of migrating data, we federated it: a structured semantic model (entities, relationships, certificates, suppliers, batches) that reads from existing systems without touching them.
On top of this layer we deployed 24+ AI agents — each purpose-built for a specific compliance workflow: extracting structured data from PDF certificates, routing CAPA actions, assessing change impact across the supply chain, and navigating regulatory requirements in natural language.
Compliance was built in from the ground up. Every action is auditable. Every document is immutable. The platform is production-adjacent and ready for pilot.
What Was Built
A production-adjacent compliance platform.
Backend
- FastAPI (Python)
- PostgreSQL
- Alembic (35 migrations)
- Redis
Frontend
- React 19
- TypeScript
- Interactive ontology graph
- Role-based dashboards
AI / Agents
- Claude (Anthropic)
- 24+ autonomous agents
- HITL routing
- PDF extraction pipeline
Security
- JWT + MFA + RBAC + ABAC
- WORM storage
- 4 Cython compiled modules
- Full audit trail
Infrastructure
- Kubernetes (Helm)
- Terraform
- Prometheus / Grafana
- Docker Compose (dev)
Integrations
- SAP connector
- Veeva connector
- Documentum (read)
- TrackWise (roadmap)
Outcomes
- Ontology layer federating data across SAP, Veeva, Documentum, and TrackWise
- 24+ AI agents automating certificate extraction, CAPA routing, and regulatory navigation
- Full 21 CFR Part 11 compliance with WORM document storage and complete audit trail
- ALCOA+ data integrity enforcement across all system interactions
- IQ/OQ/PQ validation documentation — platform ready for pilot deployment
- SAP and Veeva connector framework with selective write-back capability
- JWT + MFA + RBAC + ABAC security with four compiled security modules
- Prometheus/Grafana monitoring stack with Kubernetes deployment configuration
How It Was Built
18 months. Four phases.
Discovery & Architecture
Months 1–3Deep domain analysis of legacy system landscape (Documentum, Veeva, SAP, TrackWise). Designed the ontology schema: entities, relationships, certificates, suppliers, batches. Defined compliance requirements for 21 CFR Part 11 and ALCOA+.
Ontology & Connector Framework
Months 4–8Built the semantic data layer with federated connectors to existing systems — read-only access without data migration. Implemented the entity graph, relationship model, and cross-system linking. SAP and Veeva connectors with selective write-back capability.
AI Agent Deployment
Months 9–14Deployed 24+ AI agents: certificate extraction from PDF (CoA, CoC, GMP), change impact assessment, CAPA routing, expiry management, regulatory navigator, HITL routing, and predictive quality signals. Each agent operates within the ontology model.
Compliance & Validation
Months 15–18Full compliance build-out: WORM document storage, complete audit trail with before/after logging, IQ/OQ/PQ validation documentation, JWT + MFA + RBAC + ABAC security architecture. Four Cython-compiled security modules for production hardening.
Working in pharmaceutical compliance?
We understand regulated environments. Let’s talk about what you’re building.
Ready to build
together?
Tell us about your challenge. We'll respond within one business day with a candid view on how — and whether — we can help.