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2023-07-17Continuous complianceRegulations

Efficient Migration and Validation of SAP Workflows to the Cloud

Discover how USDM supported a global clinical trial company in transitioning its SAP workflows to the cloud.

Discover how USDM supported a global clinical trial company in transitioning its SAP workflows to the cloud.

Situation:

A global clinical trial company required an upgrade of its existing on-premises SAP ECCV6 System to SAP S/4 HANA in the cloud. However, they had limited resources and a tight deadline to execute the transition successfully. In addition, they needed to ensure that the cloud system would fully comply with the regulatory standards set by the FDA. 

Challenge:

Faced with resource constraints and regulatory requirements, the company engaged USDM Life Sciences as its trusted validation partner. USDM supported the validation efforts by providing an innovative way to validate the S/4 Hana system using a risk-based approach. USDM's team of experts worked diligently, fully validating the new system in less than four months and reducing the validation cost by 40%. USDM's Cloud Assurance managed service for SAP helped streamline the validation process by leveraging existing procedures, assets, and SAP expertise. On an ongoing basis, the managed service ensures that the company's cloud system remains in a state of continuous compliance, minimizing the customer’s burden of validation and managing SAP releases in the future.

Results:

By working with USDM, the clinical trial company was able to successfully upgrade 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 reducing its validation burden.

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Put AI to work in life sciences — with the right guardrails underneath.

Start with a structured AI Readiness Assessment: fixed-fee, executive-ready, and built to surface the highest-value workflows first.

  • Workflow inventory and risk classification
  • Business value and readiness scoring
  • FDA CSA + EU AI Act + ISO 42001 gap analysis
  • Prioritized 90-day roadmap by impact, risk, and effort

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