Validation Package for Oracle AERS

Pharmacovigilance/Drug Safety systems provide the platform for collecting, assessing and reporting adverse event information to regulatory agencies electronically or via traditional paper based methodologies. Oracle AERS supports the capture, management, reporting, and analysis of serious adverse event and product compliance cases for all medical products including drugs, medical devices, vaccines, biologics, and gene therapies from all clinical and spontaneous sources.

USDM has developed a comprehensive solution to support Life Sciences companies with comprehensive testing of regulatory requirements for AERS. Our Validation Accelerator Package (VAP) provides validation assistance with core regulatory requirements for AERS and the Oracle Clinical Suite of products.

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


  • 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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