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.
Arbour Group has successfully provided software certification services to clients requiring a methodology for the testing of application software used by outside organizations. In order to ensure integrity of software, certification of third party software applications must be performed.
The overall software certification process will include the following phases:
- Audit Test Plan: an overall plan describing the objective, scope, certification process as well as the associated documentation
- Audit Manuals: the procedures for testing the software and core data elements
- Test Data Sets: the test cases to be used for executing the test procedures
- Vendor Guide: outline of the certification procedures, testing logistics and testing manuals will be distributed in advance
- Audit Report: the actual results of testing will be documented. The summary of testing will focus on non-conformances. If no deviations are found, the report will serve as tangible assurance
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.