Transitioning from CSV to CSA: Taking a More Risked-Based Approach
It can be confusing for business stakeholders and quality teams when it comes to the what and the why of transitioning from Computer System Validation (CSV) to Computer Software Assurance (CSA). CSA requires organizations to change their validation efforts from documenting extensive test suites to focusing on more critical thinking up front. Determining the areas of the business process and/or system functionality that have a direct impact on patient safety, product quality, or system integrity will concentrate validation efforts to be clearly aligned to what needs to be tested. It is about performing the appropriate amount of targeted testing to challenge the intended use of the system, rather than testing system functionality.