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Open Text Validation Accelerator Packs

Open Text VAP


Enterprise Content Management systems provide a platform for creating, editing and managing critical business documents for an organization. Knowing where documents are, controlling access to them, finding them quickly, linking them to business processes, and archiving or destroying them at the right time in their lifecycle are fundamental requirements for regulated industry.

Open Text and USDM have partnered to provide a comprehensive solution to support Life Sciences companies in regulatory requirements for the Open Text ECM system. Our Validation Accelerator Package (VAP) provides validation assistance with core regulatory requirements for the following modules:

USDM's Open Text ECM 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 Open Text to identify upcoming patches and updates, and provides a full maintenance program for our Open Text ECM clients. Recommendations for required testing are made to ensure our clients an effective, efficient validation maintenance process.

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"
 

About USDM

USDM is a leading global consulting firm focused on life sciences.  We specialize in regulated business processes, with an emphasis on compliance and performance.

USDM provides innovative services and solutions that enable life science companies to achieve and maintain compliance across the entire enterprise.