Discover how USDM supported a global clinical trial company in transitioning its SAP workflows to the cloud — fully validating the new system in less than four months while reducing validation cost by 40%.
The Challenge
A global clinical trial company needed to upgrade its existing on-premises SAP ECC V6 system to SAP S/4 HANA in the cloud. The company faced two pressures at once: limited resources and a tight deadline to execute the transition successfully. On top of the technical migration, the new cloud system had to fully comply with the regulatory standards set by the FDA, including 21 CFR Part 11 compliance for electronic records and signatures.
For a regulated life sciences organization, a cloud migration is never just an IT project. The system underpinning clinical operations had to be validated to a defensible standard — without stalling the business or overrunning the deadline.
The Approach
Faced with resource constraints and regulatory requirements, the company engaged USDM Life Sciences as its trusted validation partner. Rather than apply blanket, exhaustive testing, USDM's team validated the SAP S/4 HANA system using a risk-based approach — focusing effort where regulatory and operational risk is greatest. This is the same modern, risk-driven philosophy that underpins computer software assurance (CSA) and keeps data integrity intact throughout the migration.
USDM's Cloud Assurance managed service for SAP streamlined the validation process by leveraging existing procedures, assets, and deep SAP expertise. Working diligently, USDM's experts fully validated the new system in less than four months and reduced the validation cost by 40%.
Compliance that doesn't stop at go-live
The engagement was designed for the long term. On an ongoing basis, the managed service keeps the company's cloud system in a state of continuous compliance — minimizing the customer's burden of validation and managing future SAP releases. As releases roll out over time, the system stays audit-ready without the company re-mobilizing a validation effort each cycle.
The Results
By working with USDM, the clinical trial company successfully upgraded its SAP workflows to a cloud-based environment without disrupting its user base. At the same time, the company met compliance requirements while benefiting from significant cost savings and a reduced validation burden.
- Validated in under four months — the new SAP S/4 HANA cloud system was fully validated on a tight deadline.
- 40% lower validation cost — achieved by leveraging existing procedures, assets, and SAP expertise.
- Zero user disruption — the migration upgraded SAP workflows without interrupting day-to-day operations.
- Continuous compliance — the managed service keeps the system audit-ready and absorbs the burden of future SAP releases.
The result is a cloud SAP environment that is faster to validate, cheaper to maintain in a compliant state, and built to stay current as the platform evolves. To migrate and validate your own SAP workflows with the same risk-based rigor, talk to USDM.