Case Study: Validating Clinical Trial Applications

by admin on July 27, 2011

The Client

Our Client is a leader in clinical trials supporting over 400-studies a year.

The Challenge

Our client needed to retire outdated systems on unsupported platforms. As a result, they developed a goal to build a new generation system allowing them to perform study management on the scalable system. Finding a partner with the right kind of testing experience and credentials to validate the system prior to rolling it out to its customers was a critical aspect of attaining their goals.

The Solution

SQA Solution performed a Free Rapid Assessment and setup a team of five: One QA Lead and four QA Engineers. The team validated the web-based clinical trial management system that was made to configure for each study. All study data was stored in centralized database and was accessed via a browser. This application allowed our customer to quickly setup a study and save time and money by maintaining a single repository. Because clinical data is governed by FDA 21 CFR Part 11 validation had to be performed.

The SQA Solution team delivered the following:

  • Test Documentation:  CSV strategy, Test Cases, Test Scenarios, traceability matrix, test Reports in accordance with GAMP‐4 and 21 CFR Part 11 utilizing URS, FRS, P& ID, process map.
  • Formal Standard Operating Procedures (SOPs) for validation determination, computer system validation and system development life cycle.
  • Computer system validation (Controls), IQ, OQ, and PQ for clinical trial software.
  • Leadership of the entire validation process during execution of assigned protocols ensuring validation deliverables were met. GDPs were utilized and CAPA’s were resolved.
  • Coordination of validation activities and resources to meet project milestones. Developed validation execution plans to reduce the protocol execution time and resources.
  • Traceability matrices to ensure all requirements were verified.
  • Validation and engineering principles to the design and implementation of systems and process modifications while regulatory requirements were met.

The SQA Solution team validated that the system met specified user and system requirements and ensured all areas were covered:

  • Installation Testing
  • Compatibility Testing
  • 21 CFR Part 11 Testing
  • Security Testing
  • Data validation Testing
  • Boundary Conditions Testing
  • Positive Negative Testing
  • User Interface Testing
  • Load and Performance Testing
  • UAT  Testing

The Benefit

  • IReduced Costs – Significantly reduced cost of quality and testing through better processes, strong on-demand resources, test management tools, and automation.
  • Improved Customer Experience – No major production issues found after go live, resulting in higher system availability, increased production stability, and stable user experience.
  • Expertise – Our testers are industry experts allowing us to implement and execute testing more efficiently. Our broad understanding of the business helps us solve key challenges and make the right decisions throughout the entire test cycle. Reduced CAPA’s by 70%.

Customer Quote:

“The SQA Solution team was able to make a big impact on our project with their experienced resources. We could not have done it without them.”

—Development Manager, San Francisco/Bay Area based Biotech.

For more on how SQA Solution can help your company improve testing processes, check us out online at or call 1.888.789.1482.


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