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 Agile PLM, validation is now available as a fixed-price, pre-written packaged solution.
The Arbour Advantage
Licensed, deployed and supported by an Agile PLM 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 Agile PLM 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.
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:
- Business Requirements model
- Validation Plan template
- Traceability Matrix
- Installation Qualification test scripts
- Operation Qualification test scripts
- Performance Qualification template
- Validation Summary Report template
Full Maintenance Program
Licensed Product Support is a maintenance program that assures validation documentation integrity for Arbour Group enterprise software compliance packages and deliverables. Updated documentation is provided in conjunction with regulatory compliance expertise that ensures an ongoing compliant environment. An Annual Regulatory Assessment and other benefits are included. Collectively, our pre-packaged validation product, maintenance program and industry professionals combine to form a comprehensive Agile PLM compliance solution.
The Arbour Assurance
This Agile PLM validation product assures you the maximum investment protection in your investment by providing the following primary benefits:
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.
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.
Whether you are installing Agile PLM 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.
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.