by USDM contributors
Download to continue reading

The U.S. Food and Drug Administration (FDA) has long encouraged a risk-based approach for software that focuses on assurance, not validation. CSA is a framework identified by the FDA that meets current CSV regulation.

The purpose of moving from computer system validation (CSV) to computer software assurance (CSA) is to reset expectations in the life sciences industry and on using technology to drive information analytics. Instead of spending 80% of your time documenting and only 20% of your time testing, the CSA methodology flips it so that 80% of your time is spent on critical thinking and applying the right level of testing to higher-risk activities, while only 20% of your time is spent documenting.

Download the eBook to learn more. > > >

Want our experts to work on your project?

Take the first step towards creating more value with USDM today.

Connect Now

We use cookies to understand how you use our site and improve your experience. This includes personalizing content and advertising. Learn more.