CSV to CSA: A New Transition in Computer System Approaches
CSV to CSA: A New Transition in Computer System Approaches If you’ve ever worked on a computer system validation project, you are probably acquainted with the new FDA’s Draft Guidance https://www.fda.gov/ on CSA ie., Computer Software Assurance. There was an ambiguity raised by FDA once stated- “Due to the complexity of software, a seemingly small …
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