Arbour Group is a trusted advisor to over 250 pharmaceutical, medical device and biotechnology companies worldwide. Let us demonstrate how we can integrate seamlessly into your organization, prove ourselves a valuable business partner and deliver effective services that reduce compliance costs.
As a global leader specializing in providing a full scope software testing and validation services, Arbour Group L.L.C. helps life sciences companies ensure that key business systems are functional and in full compliance with applicable FDA and international regulations and guidelines. We understand that computer systems are a key element of a company's risk management strategy, and aim to ensure these systems are running efficiently and accurately.
What It Includes
Arbour Group's software validation expertise includes enterprise software applications, software as a service (SaaS) and virtualized infrastructure solutions such as VMware. In addition to focusing on software systems, our validation process addresses training and the effectiveness of operating procedures. We also offer a maintenance program that provides a cost effective way to stay in compliance.
Our validation deliverables include:
- Master Validation Plan
- User Requirements and Specifications
- Risk Assessment
- Requirements Trace Matrix
- Test Protocols
- Execute test scripts
- Validation Summary reporting
Why We’re Better
Arbour is dedicated to helping your organization raise quality levels, reduce costs, and increase shareholder value. We believe in a holistic approach to compliance, delivering extensive regulatory expertise and proven methodologies to help you achieve your goals.
Arbour Group has provided us with competent validation project leadership that has enabled us to complete projects in a timely and cost effective manner.
The use of Arbour’s validation product greatly facilitated the process.
The regulatory assistance provided by Arbour Group has enabled us to enhance our compliance profile with life sciences customers.
Their Managed Services for software development and quality assurance play a key role in controlling business risk and reducing costs.
Arbour Group provided effective validation services to us and were a valuable part of the overall success of our company-wide ERP implementation.
Their integration into our multi-phase ERP roll out was seamless and assured us of comprehensive regulatory compliance.