What is Computer Software Assurance (CSA)?

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Computer Software Assurance (CSA) Definition

Computer software assurance (CSA) is a set of methods, processes, and activities that verify software systems work properly, safely, and efficiently. The FDA Computer Software Assurance for Production and Quality System Software draft guidance seeks to provide specific steps on how to ensure computer software functions as intended using an approach that utilizes only the activities commensurate with the risk of software impacting patient safety. CSA allows manufacturers to minimize their existing validation efforts and documentation burden.