CSA vs. CSV – Out with the Old, In with the New.
Computer Software Assurance, abbreviated as CSA, is a new risk-based approach for Pharma manufacturers. This method allows users to focus on areas such as product quality, safety, and speed to market. Computer Systems Validation (CSV), however, is a process that focuses on the documentation of pre-defined system requirements. This makes CSV slow, clunky, and risk-prone as the focus is primarily on meeting regulations...
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