Selective Data Transition to S/4HANA for Pharmaceutical Company
Top-20 Global Pharmaceutical Company
Business Context
The organization and its strategic environment
A $28B pharmaceutical company needed to move to S/4HANA but faced a unique challenge: FDA-regulated data retention requirements meant they could not do a simple greenfield (losing validated data), nor a brownfield (too much technical debt from 20 years of M&A). They needed a 'shell conversion' — new system structure with selective historical data.
Technology Landscape
Systems and infrastructure before DGT
SAP ECC 6.0 (acquired through 7 M&A transactions over 20 years), 4,200 custom programs, GxP-validated processes, 21 CFR Part 11 compliance requirements, integration with LIMS, MES, and clinical trial management systems.
The Challenge
What the client was facing
The company's SAP landscape was a patchwork of 7 acquired company systems merged over 20 years. A brownfield conversion would carry forward all technical debt. A greenfield would violate FDA data retention requirements for batch records and quality data. The 'selective data transition' approach was the only viable path.
The DGT Solution
How DGT addressed the challenge
DGT designed a 'Shell Conversion with Selective Data Migration' approach: convert the system structure (brownfield) but selectively migrate only validated/regulated data while leaving non-critical historical data in a decommissioned read-only archive. DataBridge managed the complex data selection rules across 340 GxP-critical tables.
DGT Accelerators Used
Delivery Approach
How DGT executed the engagement
FDA-aligned validation methodology (GAMP 5) integrated with SAP Activate. Every configuration change documented with IQ/OQ/PQ protocols. DGT's pharma-specialized team included 3 CSV (Computer System Validation) experts embedded full-time.
Governance Model
How the engagement was managed
FDA-ready governance: Quality Management System overlay, change control board with QA veto authority, full audit trail of all system changes, and quarterly FDA readiness reviews with external auditors.
Timeline & Phases
The execution roadmap
Regulatory Assessment
6 weeksGxP impact analysis, data classification (critical vs. non-critical)
Shell Conversion Design
8 weeksSystem structure conversion plan, selective data rules definition
Validation Planning
4 weeksIQ/OQ/PQ protocols, test scripts, traceability matrix
Technical Execution
14 weeksShell conversion, selective data migration, integration rebuild
Validation Execution
10 weeksFull validation cycle, FDA audit readiness, go-live
Risks Addressed
Key risks DGT mitigated during the engagement
Why DGT Won
What set DGT apart in this engagement
Outcome Metrics
Measurable before-and-after results
| Metric | Before | After DGT |
|---|---|---|
| Custom Programs | 4,200 | 1,100 |
| System Validation Status | Partial | Fully Validated |
| Batch Release Time | 5 days | 1.5 days |
| Annual Compliance Cost | $8.5M | $3.2M |
The Impact
Headline results delivered
"No other integrator understood the intersection of SAP S/4HANA and FDA compliance the way DGT did. The selective data approach saved us from an impossible choice between compliance and modernization."
Dr. Lisa Fernandez
VP IT & Digital, Top-20 Global Pharmaceutical Company