Compliance and Validation Services
USDM Supports its clients with ERP validation solutions that are risk-based and appropriately scaled to meet your unique business and regulatory requirements for ERP implementations and upgrade initiatives.
Our subject matter experts are some of the industry's most accomplished and brightest practitioners. They are well versed in business process, international regulatory compliance, and ERP technology. Our approach is both consultative and pragmatic in compliance interpretation and application. Underpinning these values are current industry and regulatory best practice – such as GAMP, ASTM 2500 ICH Q9 and ISO quality standards.
To lower the cost of systems compliance, USDM offers a ERP Validation Accelerator Pack for Oracle and SAP technology. These VAP's provide life science companies with a leading industry best practice accelerator solution to simplify compliance, increase productivity and reduce the total cost of compliance. All ERP Validation Accelerator Packs are built on the principles of GAMP and current regulatory and industry best practices containing validation plan, requirements, risk assessment, testing plans and test scripts, traceability and validation report.
USDM support models for ERP Validation
- Strategic compliance planning, training, and coaching
- Project execution and leadership
- Ongoing operational validation consulting
Solutions and Services
- ERP Validation Accelerator Packs (based on GAMP 5 principles)
- Prospective and Retrospective ERP validation services (GAMP 4 or 5)
- Validation Strategy and Planning
- Supplier assessment management
- Project governance development
- Requirements management
- Functional and technical compliance oversight
- Risk Management
- Test planning, development and execution
- Traceability management
- Assessment and summary report development
- Operational compliance support
ERP Validation Technology expertise include:
- Oracle E-Business Suite
- Oracle JD Edwards
- Oracle PeopleSoft
- SAP
- QAD Enterprise Applications (formerly QAD MFG/Pro)
- Microsoft Dynamics AX (formerly Great Plains)
To learn more about USDM and how we can assist with your compliance and business objectives, please contact:
Rebecca Meledy
888.231.0816 x161
775.213.5943 (fax)
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"Simplify, Unify and Optimize your business & compliance needs with USDM"
