The Life Sciences Software Validation Process

What is Software Validation?

Software validation testing (also known as computer system validation) evaluates an organization’s system for compliance requirements, company goals, user needs, and intended functions. Separate from the verification and certification of the system, software validation testing is an integral component of the Software Development Lifecycle (SDLC).

What does Software Validation Involve?

Software testing assesses software quality, the number of defects, the amount of run tests, and the examined system. Deviations found during system testing are documented and fixed. Testing is again executed to ensure issues are restored and no new variations have been introduced to the software. The software validation process helps improve the system’s quality while also meeting regulatory requirements set for organizations in the life sciences.

What are the Software Validation Deliverables? 

Whether organizations implement enterprise software applications, software as a service (SaaS), or virtualized infrastructure solutions such as SAP, Microsoft Dynamics, or Oracle, validation processes should address training and the effectiveness of operating procedures.

Arbour Group Validation Deliverables:

• Master Validation Plan
• User Requirements and Specifications
• Risk Assessment
• Requirements Trace Matrix
• Test Protocols
• Execute test scripts
• Validation Summary reporting

What are the Software Validation Benefits?

Organizations commit to the software validation process for confidence in their system’s functions and to confirm regulatory requirements are addressed.

Software Validation Advantages with Arbour Group:

• Manage business risk
• Evaluate regulatory compliance
• Identify risk factors
• Reduction in application development and implementation time
• Capitalize on the software systems investment
• Improve schedule visibility by ensuring project success
• Provide a qualified, third-party analysis of software systems

Have further questions on software validation testing? Contact Arbour Group to learn more about the compliance process.