This white paper explains how FDA regulated companies must validate any software that can affect product quality, safety, or effectiveness, especially ERP and other core systems. It outlines computer system validation as a lifecycle process and introduces the FDA’s newer Computer Software Assurance guidance, which adds a risk based approach rather than replacing validation. The paper offers questions to decide between internal vs. external validation support and shows how a modern, well validated ERP improves traceability, recalls, and process understanding while keeping systems consistent over time.

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