Validation Package for Oracle PLM (Agile)

Oracle Agile PLM solutions enable companies to accelerate product innovation and maximize product profitability by managing the information, processes, and decisions about products throughout their lifecycle.

Oracle and USDM have partnered to provide a comprehensive solution to support Life Sciences companies in regulatory requirements for Agile PLM.

Our Validation Accelerator Package (VAP) provides validation assistance with core regulatory requirements for Agile PLM modules, including:

  • Product Lifecycle Management
  • Product Collaboration
  • Product Governance and Compliance
  • Product Cost Management
  • Product Quality Management
  • Product Portfolio Management
  • PLM Business Intelligence
  • Engineering Data Management

USDM's Agile VAP documentation provides a pre-configured content rich set of templates, ready for customization to meet both domestic and international regulations. Our documentation templates include:

  • Validation Plan
  • User Requirements Template
  • Risk Assessment
  • Functional and Design Specification
  • Installation Qualification
  • Operational Qualification
  • Performance Qualification Template
  • Trace Matrix
  • Validation Summary Report

USDM works closely with Oracle to identify upcoming patches and updates, and provides a full maintenance program for our Agile VAP clients. Recommendations for required testing are made to ensure our clients an effective, efficient validation maintenance process.

USDM has a dedicated Agile PLM compliance team with over 8 years of experience providing validation and compliance services for Agile PLM.

Equipped with over 10 years of experience and specialization in regulated business processes, our skilled team of Oracle Agile PLM validation professionals can provide your organization with innovative and streamlined alternatives to industry standards.

USDM has been successful across many Oracle Agile PLM projects around the globe and our best-in-class validation services coupled with proven and effective methodologies can give your organization the competitive advantage it needs to thrive in today's regulated environment.

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…
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