Partnership
SAP GxP Compliance
Validate SAP in Hours and Stay Compliant with Automated Testing
Recognized worldwide as a leader in the life sciences industry, SAP helps your teams manage complex processes with ease, centralize data management, enable real-time access to information with the HANA In-Memory Database, and provide best-in-class solutions for supply chain and manufacturing operations.
USDM Life Sciences verifies that your SAP implementation meets U.S. Food and Drug Administration (FDA) 21 CFR Part 11 and other relevant regulatory requirements and manages GxP compliance for SAP customers.
How USDM and SAP S/4HANA Support Your Business Process
SAP S/4HANA cloud enterprise resource planning (ERP) equips you to scale your business globally and meet worldwide regulatory requirements. Combined with a USDM Cloud Assurance subscription, your system remains in a state of compliance after any upgrade in the cloud.
USDM’s SAP and compliance expertise keeps you fully compliant in the cloud at a fraction of the cost of traditional approaches. Using traditional Computer System Validation (CSV) or Computer Software Assurance (CSA) methodologies and automated testing tools, USDM provides an efficient and cost-effective way to achieve and sustain compliance.
USDM Cloud Assurance Benefits
Cloud Assurance provides continuous validation, compliance monitoring, and risk mitigation for cloud-based platforms in the highly regulated life sciences industry. It ensures that your system meets regulatory requirements (e.g., FDA 21 CFR Part 11, GxP) without interrupting operations.
It also:
- 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
- Maintains continuous compliance by managing SAP S/4HANA cloud releases
- Decreases risk, validation time, and cost of ownership
- Establishes a compliant IT foundation for scalable technology solutions that grow your business
- Accelerates innovation with 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.
Trust and Compliance with USDM
To support your SAP migration to the cloud and reduce your risk and cost, USDM delivers on its capabilities for trust and compliance.
- Data Integrity & Transparency. USDM ensures the accuracy, completeness, and reliability of data and provides transparency in data handling processes. This approach fosters accountability and makes data easily auditable, verifiable, and accessible to authorized parties.
- Cybersecurity & Risk Management. USDM helps you protect your sensitive data. Our experts combine cybersecurity measures with risk management practices to identify potential threats, implement security controls, and prepare incident response protocols.
- Continuous Compliance & Validation. USDM promotes a culture of compliance through automated and systematic validation processes. We deploy automation and workflows that support lifecycle management for more efficient validation processes, less manual intervention, and more consistency across systems.
- Audit Readiness & GxP Support. USDM maintains audit readiness with thorough documentation, comprehensive audits, and improvement-focused assessments. Our specialized GxP regulatory support ensures compliance across domains and our tailored training programs keep your teams up to date.
After 25 years in the industry, USDM is the trusted advisor to more than 900 life sciences companies who want to establish robust compliance cultures, maintain data integrity, and manage third-party risks.
Contact us today to learn what the SAP + USDM partnership can do for you.
Case Studies
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