Test Smarter, not Harder—
Embracing Change with
Computer Software Assurance

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What It's About

By now you have probably heard rumors and rumblings about computer system assurance (CSA), a more strategic approach to validation that is currently in draft guidance from the U.S. Food and Drug Administration. What that will look like in practice is explained in this white paper.

Who it’s for

Compliance managers, regulatory professionals, and lab personnel need this white paper to understand the new testing rationale behind CSA. There is a greater emphasis on common sense in gauging risk and on unscripted testing to identify potential issues or avenues for improvement.

How to use it

Forward-looking organizations may use this document to guide their planning for integrating or implementing new systems that will require validation. The provided scenario examples illustrate the CSA approach.