From CSV to CSA: Shift to a risk-based approach to improve software quality and FDA compliance
Computer systems validation (CSV) approaches have remained largely unchanged since the FDA first released its guidance in 1997. Meanwhile, just about everything else about the way software is built, tested, and released has changed.
With the FDA-released CSA guidelines, software validation evolved to match the speed and scalability of the systems it validates. By reducing efforts on testing and documentating everything on the same level of effort and rigor and applying that effort into critical thinking in test planning, organizations are actually able to increase quality and shrink time spent in validation.
Read this white paper to learn:
- How to identify software’s intended use and the levels of risk involved with each software component requiring validation
- How to boost assurance activity efficiency with test automation and test management
- How to maintain FDA-compliant records with integrated test validation tools such as Tricentis Vera™