Arbour Group, a member of the Oracle PartnerNetwork, announced that it  is teaming with Oracle  to provide a comprehensive solution to support FDA software validation requirements, including Part 11, for the Oracle^® E-Business Suite.

Arbour Group’s Validation Accelerator Pack (VAP) for Oracle E-Business Suite provides a complete framework to synchronize validation evidence based on specific Oracle E-Business Suite deployment use case requirements. The VAP’s pre-configured framework outlines the validation plan and defines pre-populated validation protocols to execute with reports linked to the validation trace matrix which assure Oracle E-Business Suite validation integrity. Execution of the validation process and VAP documents can also be managed in Oracle Governance, Risk and Compliance Manager to support enterprise validation best practices and assure on-going maintenance of Oracle E-Business Suite validation.

“The Oracle Life Science customer base continues to emphasize the high cost associated with FDA software validation requirements, to include Part11.  Arbour Group’s VAP for Oracle E-Business Suite provides a significant opportunity for our Life Science customers to reduce the cost and deployment time associated with this critical business requirement of the FDA,” says Todd Hein, Senior Director, Oracle Life Science Business Unit.

“The Arbour Group VAP for Oracle E-Business Suite combined with the Oracle Governance, Risk and Compliance Manager provides an enterprise solution for achieving validation and maintaining a validated state across the enterprise IT platform. This combination enables validation best practices which help assure validation integrity and significant reduction in validation costs” says Archie O’Leary, Vice President Arbour Group.

About the Oracle PartnerNetwork
Oracle PartnerNetwork is a global business network of more than 20,000 companies who deliver innovative software solutions based on Oracle software. Through access to Oracle’s premier products, education, technical services, marketing and sales support, the Oracle PartnerNetwork program provides partners with the resources they need to be successful in today’s global economy. Oracle partners are able to offer their customers leading-edge solutions backed by Oracle’s position as the world's largest enterprise software company. Partners who are able to demonstrate superior product knowledge, technical expertise and a commitment to doing business with Oracle qualify for the Certified Partner levels. http://oraclepartnernetwork.oracle.com.

About Arbour Group

Arbour Group LLC is a leading provider of regulatory products and services for pharmaceutical, medical device and biotechnology companies worldwide.

Arbour Group's regulatory products include packaged validation protocols that help clients ensure that key enterprise software solutions are functional and in compliance with applicable regulations to minimize business risk. Regulatory services are based on a results-oriented software testing process that not only assures compliance and functionality, but also supports product quality and reliability.

Arbour Group has been lowering the cost of compliance since 1990 for over 100 multinational companies with a global presence including United States offices in California, Illinois, and New Jersey, along with facilities in Dublin, Ireland and Dubai, U.A.E.

For more information, contact Arbour Group at www.arbourgroup.com.

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