What is Verification and Validation?
FDA Definition and Explanation VALIDATION Software validation is “establishing by objective evidence that all software requirements have been implemented correctly and completely and are traceable to system requirements” [Ref: NIST 500-234]. FDA considers software validation to be “confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled.” [Ref: FDA General Principles of Software Validation, Final Guidance, January 2002]. Software validation is essentially a design verification function as defined in FDA’s Quality System Regulation (21 CFR 820.3 and 820.30) and includes all of the verification and testing activities conducted throughout the software life cycle. Design validation encompasses software validation, but goes further to check for proper operation of the software in its intended use environment. VERIFICATI
