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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.
The ultimate design review, if successful, therefore triggers the product launch or product release. The conduct of design reviews is compulsory as part of design controls, when developing products in certain regulated contexts such as medical devices. By definition, a review must include persons who are external to the design team.
Furthermore, many of the IMP events are fixed by customer-defined milestones (e.g., Preliminary or Critical Design Review, Production Deliver, etc.) while intermediate events are defined by the Supplier (e.g., integration and test, software build releases, Test Readiness Review, etc.).
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Work breakdown structures that subdivide work by project phases (e.g. preliminary design phase, critical design phase) must ensure that phases are clearly separated by a deliverable also used in defining entry and exit criteria (e.g., an approved preliminary or critical design review).
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The preliminary design review evaluates the adequacy of the preliminary design. In the following phase, detailed design is drawn and coded for the system as a whole and all the subsystems, and a critical design review is performed where it is evaluated whether the design is sufficiently detailed to fabricate, integrate, and test the system. [1] [2]
President-elect Donald Trump had not been terribly successful in suing media organizations until this weekend when ABC News agreed to settle a closely-watched defamation case he brought against ...