Article | April 8, 2022

5 Answers To FDA Computer System Validation Questions

By Sarah Beale


Computer system validation (CSV) can drag on for months. However, it doesn’t have to. The U.S. Food and Drug Administration (FDA) has clearly indicated that a risk-based approach is compliant and significantly reduces the burden on life sciences companies. At MasterControl, we’ve developed a patented validation software  to help our customers validate in minutes and we have plans to make the process even faster in the future.

In a recent presentation on validation, MasterControl Vice President of Product Management Erin Wright discussed these tools and our upcoming validation process. During the Q&A at the end of the presentation, Wright answered the following validation questions.

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