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As a global leader specializing in a full scope of software testing services and validation solutions, Arbour Group helps pharmaceutical, medical device and biotechnology companies in the Life Sciences ensure that key business systems are functional and fully compliant 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 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 FDA 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 utilizing commercial and proprietary tools
  • Reporting the results of our comprehensive testing, including completeness metrics
  • Repeating testing to accommodate ongoing upgrades and system maintenance

Our validation testing process primarily focuses on FDA computer system validation while also evaluating the training and organization of your personnel and the effectiveness of your operating procedures so far as it affects the use of the system.

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 validation testing services have the benefit of evaluating regulatory compliance, identifying risk factors, enhancing productivity through a reduction in application development and implementation time, capitalizing on the investment in software systems and benchmarking return on equity, improving schedule visibility by ensuring project success and providing qualified, third-party testing of software systems.

What is the Difference Between Verification and Validation in Software Testing?

Where FDA computer system 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.

Arbour Group's Validation Testing Expertise

Arbour Group's software validation FDA expertise includes enterprise software applications, software as a service (SaaS), and virtualized infrastructure solutions such as SAPOracle, or Microsoft Dynamics. In addition to focusing on software systems, our validation process addresses training and operating procedures' effectiveness. 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 Report

Why Arbour Group for Software Testing Validation and Verification

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. 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 and practices
  • A comprehensive library of pre-defined test cases
  • Dedicated international testing facilities
  • Wide range 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 Group's Software Validation and Verification services, contact us today.


Learn about our Software Testing validation and verification services in Europe.



The Arbour Advantage

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.