FDA software validation guidance
FDA software validation guidance refers to the framework and recommendations provided by the U.S. Food and Drug Administration (FDA) to ensure that software used in regulated environments, particularly in the Life Sciences sector, meets required standards for quality and compliance. This guidance outlines best practices for validating software applications throughout their lifecycle, including design, development, implementation, and maintenance. It emphasizes the importance of thorough documentation, risk assessment, and testing processes to confirm that software performs reliably and safely. By adhering to these guidelines, organizations can enhance product quality, ensure regulatory compliance, and minimize risks associated with software failures in critical operations.
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