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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 .
Software management reviews are conducted by management representatives to evaluate the status of work done and to make decisions regarding downstream activities. Software audit reviews are conducted by personnel external to the software project, to evaluate compliance with specifications, standards, contractual agreements, or other criteria.
The purpose of a peer review is to provide "a disciplined engineering practice for detecting and correcting defects in software artifacts, and preventing their leakage into field operations" according to the Capability Maturity Model . When performed as part of each Software development process activity, peer reviews identify problems that can ...
Most federal regulatory agencies in the United States government must comply with specific peer review requirements before the agencies publicly disseminate certain scientific information. These requirements were published in a Peer Review Bulletin [1] issued by the White House Office of Management and Budget (OMB), which establishes ...
Software quality management. Software Quality Management ( SQM) is a management process that aims to develop and manage the quality of software in such a way so as to best ensure that the product meets the quality standards expected by the customer while also meeting any necessary regulatory and developer requirements, if any.
The SDR is a technical review conducted to evaluate the manner in which a project's system requirements have been allocated to configuration items, manufacturing considerations, next phase planning, production plans, and the engineering process that produced the allocation. This review is conducted when the system definition is at a point where ...
A Software management review is a management study into a project's status and allocation of resources. It is different from both a software engineering peer review, which evaluates the technical quality of software products, and a software audit, which is an externally conducted audit into a project's compliance to specifications, contractual ...
A software technical review is a form of peer review in which "a team of qualified personnel ... examines the suitability of the software product for its intended use and identifies discrepancies from specifications and standards. Technical reviews may also provide recommendations of alternatives and examination of various alternatives" ( IEEE ...