A consultative and pragmatic approach in compliance and application for your ERP needs.
ERP validation solutions that are risk-based and appropriately scaled to meet your unique business and regulatory requirements for ERP implementations and upgrade initiatives.
Enterprise Resource Planning (ERP) systems often represent the highest risk area for life sciences product manufacturers due to increased integration with shop floor, quality, and third-party distribution systems. Well versed in business process, international regulatory compliance, and ERP technology, our subject matter experts are some of the industry’s most accomplished and brightest practitioners. Underpinning these values are current industry and regulatory best practices – such as GAMP, ASTM 2500 ICH Q9 and ISO quality standards.
Our ERP Validation Accelerator Pack for Oracle and SAP technologies, provides companies the accelerator solution to simplify compliance, increase productivity, and reduce the total cost of systems 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
- 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 managementFunctional and technical compliance oversight
- Risk Management
- Test planning, development and execution
- Traceability management
- Assessment and summary report development
- Operational compliance support