Moving to the Cloud can be an easy choice for regulated Life Science companies. USDM's Cloud VAP offers a subscription compliance model.
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.
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