Protecting patient data. Powering
healthcare operations
“One SAP system. PHI secured in-country. Pharmacovigilance without borders.”
HIPAA.
GDPR.
GxP
ISO 13485
FDA/EMA
PHI: in-country only
HIPAA · GDPR · GxP audit-ready
6–8 mo first jurisdiction
The challenge
- PHI must stay within national borders — Germany, UK, France, and the Netherlands each add requirements beyond GDPR.
- HIPAA for US patient data plus GDPR for EU operations compounds compliance complexity.
- Separate SAP instances per country create pharmacovigilance blind spots.
- Clinical trial data can't be aggregated without risking patient privacy.
- Adverse event reporting needs global visibility, but data can't legally cross borders.
How TERRA solves it
- One central SAP S/4HANA for manufacturing, supply chain, and financials.
- PHI is automatically routed to in-country regional stores at the point of entry.
- Pharmacovigilance teams get aggregated market data without ever seeing individual PHI.
- Multi-country clinical trials: patient data stays in its home country; only anonymous results are aggregated.
- Complete HIPAA and GDPR audit trails, including per-record access logs.
- GxP, ISO 13485, and medical device / pharma operations fully supported.
Where This Fits
Built for healthcare & life sciences teams like these
Medical device manufacturers with European service and warranty operations
Pharmaceutical companies managing patient assistance programs across markets
Clinical research organizations running multi-country trials
Healthcare providers with international patient populations
Life sciences companies with post-market pharmacovigilance obligations
TERRA vs. The Old Way
The multi-instance approach side by side
| Separate SAP per country | TERRA™ | |
|---|---|---|
| Systems to manage | Separate SAP instance per country | One global SAP S/4HANA instance |
| Typical cost vs. TERRA | 3–5x higher licensing, hosting, admin | 40–60% lower total cost of ownership |
| Adding a new jurisdiction | Multi-million-dollar re-implementation | Configuration change, live in 6–8 weeks |
| Global reporting | Fragmented, manual reconciliation | Real-time, compliant, from one system |
| Regulatory audit readiness | Manual evidence gathering per country | Audit-ready reports on demand |
| End-user experience | Different system per region | One familiar SAP interface everywhere |