NCIt definition : A process of 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.;
Alternative definition : CDISC-GLOSS: 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. NOTE: Validating
software thus should include evaluation of the suitability of the specifications to
ensure user needs and intended uses can be fulfilled on a consistent basis (21 CFR
820.20). General Principles of software Validation; Final Guidance for industry and
FDA staff, Jan 11, 2002. ISOIEC/IEEE 12207:1995 3.35; 21 CFR 820.20; 21 CFR 11.10(a);
ISO 9000-3; Huber, l. (1999) See also validation, verification. Verification usually
concerns confirmation that specified requirements have been met, but typically refers
to the tracing of requirements and evidence of conformance in the individual phases
or modules rather than suitability of the complete product. Validation is, the evaluation
of software at the end of the software development process to ensure compliance with
the user requirements (ANSI/ASQC A3-1978) and should not be thought of as an end-to-end
verification. See also validation.;
Currated CISMeF NLP mapping