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20 Years of Assuring Life Science Compliance Solutions

Copyright © 2016 Arbour Group LLC. All rights reserved.

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Leading Provider of

Oracle E-Business Suite

Validation Accelerator Package. Assured Regulatory Compliance.

Business Requirement Model

 

Validation Template

 

Traceability Matrix

 

Installation Qualification Test Scripts

 

Operation Qualification Test Scripts

 

Performance Qualification Template

 

Validation Summary Report Template

 

Compliance Offering

As an alternative to manual, labor-intensive validation efforts, Arbour Group’s ready off-the-shelf validation package incorporates industry compliance best practices to include:

 

SEE WHAT OUR CLIENTS ARE SAYING ABOUT US

"The staff provided by Arbour Group have been skilled and well prepared to take on the variety of validation projects we have assigned to them. Their experience and expertise has helped enhance our validation assessment, planning and execution performance."

Manager, Quality & Compliance at a Fortune 50 company

Arbour Group has performed validation projects for us for over nine years. The projects are always well managed and the staff provides valuable insight in terms of regulatory interpretation and industry best practices.

Associate Director, Quality & Regulatory for a European-based Fortune 50 pharmaceutical company

ARBOUR GROUP IS TRUSTED BY OVER 250 COMPANIES LIKE YOURS

Here are some of the pharmaceutical, medical device, and biotechnology companies we have worked with.

The leading commercial business software now has a pre-packaged validation solution for the life sciences industries. If you are newly implementing or planning an upgrade to Oracle E-Business Suite, validation is now available as a fixed-price, pre-written packaged solution.

 

Request information about our services

Licensed, deployed and supported by an Oracle E-Business Suite partner, the pre-packaged validation solution is based on Arbour Group’s extensive industry knowledge and expertise accumulated from years of experience with pharmaceutical, medical device and biotechnology companies. Arbour Group’s Oracle E-Business Suite compliance product allows you to meet your obligations to both domestic and international authorities (e.g. BfArM, FDA, HPRA, MHRA, and TGA) in a timely and cost effective manner.

 

The Arbour Advantage

Arbour Group provides updates when patches and support packages are delivered by Oracle E-Business Suite as well as when regulations change. As we are a global organization with offices and professional staff throughout the US, EMEA and Asia, Arbour Group is able to support you continuously to help your company achieve and maintain regulatory compliance of your software systems. Collectively, our pre-packaged validation product, maintenance program and industry professionals combine to form a comprehensive Oracle E-Business Suite compliance solution.

Whether you are installing Oracle E-Business Suite for the first time, converting from a legacy system or applying a patch, Arbour Group’s pre-packaged validation product will help you manage your business risk quickly and reliably.

 

 

Shorter Timeframes: Our time-tested, field proven pre-packaged validation product certifies compliance in an optimally expedient and secure manner. This means you are able to accelerate the time-to-value of your commercial business software investment. 

 

Full Maintenance Program

Regulatory Agency Approval: Properly validated solutions are more likely to avoid regulatory scrutiny in the form of citations and audits. These time consuming and disruptive events can pose a real business risk as it relates to Agency approval of new product introductions and brand acceptance in the marketplace.

 

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