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Computer system validation (CSV) is a time-consuming process for most regulated companies. Someone needs to comb through the release notes, every feature needs to be tested and countless screenshots need to be taken. But does a company really need to do any of that? Certainly, the U.S. Food and Drug Administration (FDA) requires companies to validate its software to ensure it works for its intended use. But a company can validate their software in a much shorter amount of time using a risk-based approach.
Read the full article here: The Next Generation of Software Is Self-Validating