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Requirements analysis and negotiation – Requirements are identified (including new ones if the development is iterative), and conflicts with stakeholders are solved. Both written and graphical tools (the latter commonly used in the design phase, but some find them helpful at this stage, too) are successfully used as aids.
Requirements can be said to relate to two fields: Product requirements prescribe properties of a system or product. Process requirements prescribe activities to be performed by the developing organization. For instance, process requirements could specify the methodologies that must be followed, and constraints that the organization must obey.
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.
The engineering design process, also known as the engineering method, is a common series of steps that engineers use in creating functional products and processes. The process is highly iterative – parts of the process often need to be repeated many times before another can be entered – though the part(s) that get iterated and the number of such cycles in any given project may vary.
Requirements management is the process of documenting, analyzing, tracing, prioritizing and agreeing on requirements and then controlling change and communicating to relevant stakeholders. It is a continuous process throughout a project.
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 software requirements specification (SRS) is a description of a software system to be developed.It is modeled after the business requirements specification.The software requirements specification lays out functional and non-functional requirements, and it may include a set of use cases that describe user interactions that the software must provide to the user for perfect interaction.
Requirements Triage or prioritization of requirements is another activity which often follows analysis. [4] This relates to Agile software development in the planning phase, e.g. by Planning poker, however it might not be the same depending on the context and nature of the project and requirements or product/service that is being built.