Validating business requirements
In such a situation, the specifications of the parts/devices/software and restructuring proposals should be appended to the qualification document whether the parts/devices/software are genuine or not.
Torres and Hyman have discussed the suitability of non-genuine parts for clinical use and provided guidelines for equipment users to select appropriate substitutes which are capable to avoid adverse effects.
" "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.
This often involves acceptance of fitness for purpose with end users and other product stakeholders. It is sometimes said that validation can be expressed by the query "Are you building the right thing?
It is entirely possible that a product passes when verified but fails when validated.
This can happen when, say, a product is built as per the specifications but the specifications themselves fail to address the user's needs.
Verification can be in development, scale-up, or production. Validation is intended to ensure a product, service, or system (or portion thereof, or set thereof) results in a product, service, or system (or portion thereof, or set thereof) that meets the operational needs of the user.
For a new development flow or verification flow, validation procedures may involve modeling either flow and using simulations to predict faults or gaps that might lead to invalid or incomplete verification or development of a product, service, or system (or portion thereof, or set thereof).
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The typical example of such a case could be the loss or absence of vendor's documentation for legacy equipment or do-it-yourself (DIY) assemblies (e.g., cars, computers etc.) and, therefore, users should endeavour to acquire DQ document beforehand.
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