(1) provision of objective evidence that a given item fulfils specified requirements; note that, when applicable, measurement uncertainty should be taken into consideration.
(2) confirmation, through the provision of objective evidence, that specified requirements have been fulfilled
(3) the provision of 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


(1) Joint Committee for Guides in Metrology (JCGM/WG 2) 200:2012 & ISO/IEC Guide 99-12:2007, International Vocabulary of Metrology – Basic and General Concepts and Associated Terms (VIM),

(2) ISO 9000:2015(en), Quality management systems - Fundamentals and vocabulary

(3) Center for Devices and Radiological Health (CDRH), General Principles of Software Validation; Final Guidance for Industry and FDA Staff, CBER CDRH/OC Doc. N. 938, January 11, 2002. Publicly available via


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