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In engineering, a requirement is a condition that must be satisfied for the output of a work effort to be acceptable. It is an explicit, objective, clear and often quantitative description of a condition to be satisfied by a material, design, product, or service.
A design specification (or product design specification) is a document which details exactly what criteria a product or a process should comply with. [1] If the product or its design are being created on behalf of a customer, the specification should reflect the requirements of the customer or client. [2]
Requirements engineering (RE) [1] is the process of defining, documenting, and maintaining requirements [2] in the engineering design process. It is a common role in systems engineering and software engineering .
Requirements analysis is critical to the success or failure of a systems or software project. [3] The requirements should be documented, actionable, measurable, testable, [4] traceable, [4] related to identified business needs or opportunities, and defined to a level of detail sufficient for system design.
A requirement specification is a documented requirement, or set of documented requirements, to be satisfied by a given material, design, product, service, etc. [1] It is a common early part of engineering design and product development processes in many fields.
Software requirements [1] ... Model-based systems engineering (MBSE) is the formalised application of modelling to support system requirements, design, analysis ...
In 21CFR820.3(h), design review is described as "documented, comprehensive, systematic examination of the design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems". The FDA also specifies that a design review should include an independent reviewer.
Verification: Design verification is confirmation by examination and provision of objective evidence that the specified input requirements have been fulfilled. Verification activities such as modelling, simulations, alternative calculations, comparison with other proven designs, experiments, tests, and specialist technical reviews.