Once the manufacturer has determined whether a software feature, function, or operation poses a high process risk (a quality problem that may foreseeably compromise safety), the manufacturer should identify the assurance activities commensurate with the medical device risk or the process risk.
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CSA Risk Framework, CSV– CSA – GAMP – DITOPIC: CSA Risk Framework Generally, the risk-based approach entails systematically identifying reasonably foreseeable software failures, determining whether such a failure poses a high process risk, and systematically selecting and performing assurance activities commensurate with the medical device or process risk, as applicable. The risk-based analysis for production or quality system software considers those factors that
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CSA Risk Framework, CSV– CSA – GAMP – DI