White Paper — Sponsored Content

Transitioning from CSV to CSA: Taking a More Risked-Based Approach

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.

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. Download this whitepaper for a detailed approach to a successful transition to CSA.

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