This paper begins by reviewing what the shift from Computer System Validation (CSV) to Computer Software Assurance (CSA) is, as both business and quality teams are often confused about the what and the why. Fundamentally, the intent of transitioning from CSV to CSA in the life science industry is to change the focus of validation efforts from documenting extensive test suites to executing more extensive system testing to ensure proper functionality.
This shift in approach to validation aims to realign effort to planning and preparation first, then defining the testing to be performed, and finally test execution and documentation.
Authored by Kelly Harewood, VP of Quality & Compliance, Verista
Keith Aurin, Director, IT Enterprise Systems, Verista