• Enterprise Resource Planning

Enterprise Resource Planning

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

  • Strategic compliance planning, training, and coaching
  • Project execution and leadership
  • Ongoing operational validation consulting

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

 

Testimonials

  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
See all Testimonials