SAP S/4HANA GxP Compliance

SAP GxP Compliance

SAP S/4HANA: SAP GxP Compliance in the Cloud


USDM Life Sciences provides world-class solutions that enable life sciences companies that are running SAP to meet 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 that allows for an efficient process. Our approach keeps SAP fully compliant in the cloud at a fraction of the cost versus traditional approaches. SAP and USDM can offer a Roadmap to the cloud that allows customers to materialize cloud benefits and keeps the systems in a complaint state while receiving upgrades.


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


In partnership with USDM Life Sciences, SAP S/4HANA allows regulated medical devices and life sciences companies to continuously meet all their compliance needs covering the solution and regulation simultaneously with our Cloud Assurance Subscription program. Any upgrade in the cloud is comprehensively assessed and supported to ensure the system remains in a state of compliance. 

How USDM + SAP S/4HANA Can Support Your Business Process

USDM’s Cloud Assurance ™ is a managed service where USDM handles the compliance workload, from risk assessment and validation, to continuous compliance in the cloud. Utilizing traditional Computer System Validation (CSV) or Computer Software Assurance methodologies (CSA), along with our automated testing tools, USDM provides Oracle SCM Cloud customers with an efficient and cost-effective way to achieve and sustain compliance.


USDM Cloud Assurance Benefits

  • Quickly and efficiently validate the system to bring it into a compliant state for GXP regulations
  • Significantly reduce implementation and validation time with a solid Roadmap to the cloud 
  • Enables the move from on-prem to the cloud for SAP life science customers
  • Maintains continuous compliance by managing SAP S/4HANA Cloud releases through Cloud Assurance
  • Significantly reduces the risk and validation time while decreasing the cost of ownership
  • Provides a structured journey map to identify strategic business initiatives made possible by SAP
  • Scalable technology solutions to grow your business and establish your compliant IT foundation
  • Extensive digital transformation services, including people and process changes to drive adoption
  • Utilize a methodology and toolkit successfully audited by regulatory agencies 
  • Accelerate 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 can offer a set of roadmaps to support your SAP migration to the cloud, allowing you to reduce your risk and cost. 

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