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Report MasterControl - 8 Tips for Compliant and Quick Software Validation

8 Tips for Compliant and Quick Software Validation

Computer system validation (CSV) tends to be a sore spot. That’s not very surprising since some professionals spend months on validation. There’s no regulatory requirement for GxP software validation to take that long. In fact, following the guidance from the U.S. Food and Drug Administration (FDA), companies can validate in a matter of hours for their initial implementation and a matter of minutes for upgrades.

Report Snap Shot

"Regulated companies should seek to maximize supplier involvement throughout the system life cycle in order to leverage knowledge, experience, and documentation, subject to satisfactory supplier assessment"