Validating business requirements
In the case when genuine parts/devices/software are demanded by some of regulatory requirements, then re-qualification does not need to be conducted on the non-genuine assemblies.
Instead, the asset has to be recycled for non-regulatory purposes.
filters) or springs stretch out, requiring recalibration, and hence re-certification is necessary when a specified due time lapse.
Re-qualification of machinery/equipment should also be conducted when replacement of parts, or coupling with another device, or installing a new application software and restructuring of the computer which affects especially the pre-settings, such as on BIOS, registry, disk drive partition table, dynamically-linked (shared) libraries, or an ini file etc., have been necessary.
"Independent verification and validation" can be abbreviated as "IV&V".
In practice, as quality management terms, the definitions of verification and validation can be inconsistent. In the development phase, verification procedures involve performing special tests to model or simulate a portion, or the entirety, of a product, service or system, then performing a review or analysis of the modeling results.
Otherwise, the process of IQ, OQ and PQ is the task of validation.
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Verification and validation are independent procedures that are used together for checking that a product, service, or system meets requirements and specifications and that it fulfills its intended purpose.
" "Building the right thing" refers back to the user's needs, while "building it right" checks that the specifications are correctly implemented by the system.
In some contexts, it is required to have written requirements for both as well as formal procedures or protocols for determining compliance.