FDA’s rules for software are contained in General Principles of Software Validation; Final Guidance for Industry and FDA Staff. The language specifically defines verification and validation. It also says that “software testing is one of many verification activities intended to confirm that software development output meets its input requirements. Other verification activities include various static and dynamic analyses, code and document inspections, walkthroughs, and other techniques.”

Return to "Caution: V&V May Be Hazardous to Software Quality."