Validation Package for Argus Drug Safety

Oracle Argus Safety is an advanced and comprehensive adverse events (AE) management system that helps life sciences companies ensure regulatory compliance, drive product stewardship, and integrate safety and risk management into one comprehensive platform. Argus Safety is industry-proven and accepted, having been used for more than a decade at leading pharmaceutical, biotech, CRO, and medical device manufacturers. 

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

USDM's Argus 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 Argus clients. Recommendations for required testing are made to ensure our clients an effective, efficient validation maintenance process.

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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