Software validation is a requirement of the Quality System regulation. Validation requirements apply to software used as components in medical devices, to software that is itself a medical device, and to software used in the production of the device or in the implementation of the device manufacturer’s quality system. Software is frequently purchased off-the-shelf for a particular intended use so, it should have documented requirements that fully define its intended use, to show that the software is validated for its intended use.
Device manufacturers may use the same procedures and records for compliance with quality system and design control requirements, as well as for pre-market submissions to FDA.
Software verification provides objective evidence that the design outputs of a particular phase of the software development life cycle meet all of the specified requirements for that phase. Software testing is one of many verification activities intended to confirm that software development output meets its input requirements.
Software validation is a part of the design validation for a finished device but is not separately defined in the Quality System regulation. In practice, software validation activities may occur both during, as well as at the end of the software development life cycle to ensure that all requirements have been fulfilled. A conclusion that software is validated is highly dependent upon comprehensive software testing, inspections, analyses, and other verification tasks performed at each stage of the software development life cycle.