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This paper begins by reviewing what the shift from Computer System Validation (CSV) to Computer Software Assurance (CSA) is, as

CSV vs. CSA: What Are the Main Differences?

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Risk-Based Computerized System Validation (CSV) and Computer Software Assurance (CSA) - Old Wine in a New Bottle? - Kvalito

FDA Move from Software Validation to Computer Software Assurance (CSA)

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CSV vs. CSA: What Are the Main Differences?

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Computer System Validation to Computer Software Assurance