Partnership

SAP GxP Compliance

Validate SAP in Hours and Stay Compliant with Automated Testing

SAP has a long history in the life sciences industry. It helps companies of all sizes operate efficiently and has been recognized worldwide as a leader in this market. Using SAP solutions allows various business functions by centralizing data management, helping to manage complex processes with ease, enabling real-time access to information with the HANA In-Memory Database, and providing best-in-class solutions for Supply Chain & Manufacturing operations.

USDM Life Sciences provides world-class solutions that enable life sciences companies running SAP to meet U.S. Food and Drug Administration (FDA) 21 CFR Part 11 and other relevant regulatory requirements. USDM delivers a trustworthy service that expertly manages GxP compliance for SAP customers. Our team combines deep SAP and compliance expertise and delivers an efficient process. Our approach keeps SAP fully compliant in the cloud at a fraction of the cost of traditional approaches. SAP and USDM offer a roadmap to the cloud that allows customers to materialize cloud benefits and keep their systems in a compliant state while receiving upgrades.

In partnership with USDM Life Sciences, SAP S/4HANA allows regulated medical devices and life sciences companies to continuously meet all their compliance needs. With a USDM Cloud Assurance subscription, your system remains in a state of compliance after any upgrade in the cloud.

How USDM and SAP S/4HANA Support Your Business Process

USDM’s Cloud Assurance™ handles your compliance workload from risk assessment to validation to continuous compliance in the cloud. Using traditional Computer System Validation (CSV) or Computer Software Assurance (CSA) methodologies and automated testing tools, USDM provides SAP customers with an efficient and cost-effective way to achieve and sustain compliance.

USDM Cloud Assurance Benefits

Validates a system quickly and efficiently to bring it into a compliant state for GxP regulations
Reduces implementation and validation time with a solid roadmap to the cloud
Moves life sciences customers from on-premises to the cloud for SAP
Maintains continuous compliance by managing SAP S/4HANA cloud releases
Decreases risk, validation time, and cost of ownership
Provides a structured journey map to identify strategic business initiatives made possible by SAP
Establishes a compliant IT foundation for scalable technology solutions that grow your business
Drives adoption of digital transformation services
Uses a methodology and toolkit successfully audited by regulatory agencies
Accelerates innovation with a platform of compliant-ready solutions

SAP is currently promoting the upgrade to the SAP S/4HANA version to their customer base and aims to complete this by 2027. The earlier your company plans for this move, the less complex it will be to transition to the cloud. USDM offers a set of roadmaps to support your SAP migration to the cloud to help reduce your risk and cost.

Case Studies

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