• Governance, Risk, & Compliance

 
 
 

Validation Accelerator Packs for Oracle Governance, Risk and Compliance Suite

Governance, Risk and Compliance (GRC) for life sciences companies represents a unique key results area to simplify, unify and optimize compliance investments by replacing fragmented 'layers and silos' with a clean and harmonized program.  When combined with risk-control and compliance matrices and mapping of the regulations against common control elements across multiple organizations and business units, a comprehensive, harmonized GRC solution can be achieved which provides full transparency into business risk and performance, fosters predictable business performance and ensures compliance sustainability.

USDM Life Sciences and Oracle have partnered to provide a comprehensive solution to support life sciences companies in regulatory requirements for Governance, Risk and Compliance (GRC). Our Validation Accelerator Package (VAP) provides validation assistance with core regulatory requirements for the following GRC functionality:

  • Risk assessment, control design, policy creation, control monitoring and case management 
  • Real time compliance, risk and performance management information 
  • Risk-control and compliance matrices and mapping of the regulations against common control elements
  • Content security, records retention and identity management
  • Segregation-of-duties, IT configuration and change management processes

USDM Life Sciences' Oracle GRC Suite of VAP documentation provides a pre-configured, content rich set of templates, ready for customization to meet both domestic and international regulations. 

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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