GRC

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.

Oracle and USDM Life Sciences 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 
  • Rsk-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. 

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 Life Sciences works closely with Oracle to identify upcoming patches and updates, and provides a full maintenance program for our Oracle GRC VAP clients. Recommendations for required testing are made to ensure our clients an effective, efficient process for maintaining a validated state of compliance.

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

USDM Life Sciences has been successful across many Oracle GRC validation 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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