Computer software assurance

FDA's CSA guidance focuses effort on software whose failure could affect product quality or patient safety. Lower-risk tools can be assured with lighter testing, which replaces the habit of documenting every tool in the same depth.

Computer software assurance is a risk-based approach for establishing and maintaining confidence that software is fit for its intended use.

FDA guidance: Computer Software Assurance for Production and Quality Management System Software (February 2026), Section V, Computer Software Assurance