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 specialising in a full scope of software testing services and validation solutions, Arbour Group helps life sciences companies ensure that critical business systems are functional and fully compliant with applicable MHRA, FDA, EMA and other regulations and guidelines. We understand that computer systems are crucial in a company's risk management strategy and aim to ensure these systems are running efficiently and accurately.
What is Software Validation Testing?
Validation testing is ensuring software applications meet their intended use by comprehensively testing to specifications and applicable regulations that may include software validation regulatory requirements. To facilitate validation of your systems in a time and cost-efficient manner, Arbour follows a proven software testing process:
- Conducting an assessment of your critical needs
- Drafting project specifications for company approval
- Setting finite objectives for each phase of the software testing process
- Developing a testing script matrix tailored to meet objectives
- Executing the appropriate testing mechanisms utilising commercial and proprietary tools
- Reporting the results of our comprehensive testing, including completeness metrics
- Repeating testing to accommodate ongoing upgrades and system maintenance
The validation testing process focuses on software systems, evaluates your personnel's training and organisation and the effectiveness of your operating procedures.
What are Software Validation Testing Benefits?
Validation testing is an essential part of business risk management directly related to your company's software systems. Software testing services have the benefit of evaluating regulatory compliance, identifying risk factors, enhancing productivity through a reduction in application development and implementation time, capitalising on the investment in software systems and benchmarking return on equity, improving schedule visibility by ensuring project success and providing a qualified, third-party analysis of software systems.
What is the Difference Between Verification and Validation in Software Testing?
Where software validation is the process of evaluating the final product to make sure it is working to company requirements and regulations, verification checks that software meets specifications of quality. Verification may help determine if a software is efficient through quality assurance but does not ensure that it is working to its intended use like software validation. Arbour Group's software certification services may help determine the verification integrity of your company's software.
What Arbour's Software Testing Validation Includes
Arbour Group's software validation expertise includes enterprise software applications such as SAP, Oracle, or Microsoft Dynamics, whether in the cloud on on-premise. In addition to focusing on software systems, our validation process addresses procedural controls related to data integrity, change management and training records. We also offer a maintenance program that provides a cost-effective way to stay in compliance.
Our validation deliverables include:
- Validation Plan
- User Requirements and Functional Specifications
- Risk Assessment
- Requirements Trace Matrix
- Test Protocols
- Executed/documented test scripts
- Validation Summary Report
Why Arbour Group for Software Testing Validation and Verification
Arbour is dedicated to helping your organisation 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. Our expertise includes pharmaceutical and biotechnology systems and medical device software validation. From major multinational firms to small, medium-sized businesses, companies in the life sciences choose Arbour Group based on the depth of our experience and our reputation for quality solutions and services at every level of delivery.
Arbour's Software Validation and Verification services are noted for:
- Knowledgeable software testing specialists
- Hands-on experience with regulatory agencies
- Time-tested valuable methodologies
- A comprehensive library of predefined test cases
- Dedicated international testing facilities
- Vast knowledge of commercial software testing tools
While technical considerations are an integral part of the software process, we ensure compliance and functionality during and enforce your marketing programs, complement new business initiatives, and respond competitively to your customers' needs.
To further discuss Arbour's Software Validation and Verification services, contact us today.
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.