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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.
Download as PDF; Printable version; In other projects Appearance. ... Redirect page. Redirect to: Design review (U.S. government)#Preliminary Design Review (PDR)
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).
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]
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Taco Bell is the strongest performer of Yum Brand’s portfolio and often outperforms sister brands KFC and Pizza Hut. The chain reported a 4% increase in same-store sales in Yum’s most recent ...
One objective of a good design review is to examine the results of validation testing, making all product weaknesses visible. This examination involves applying another GD 3 concept, design review based on test results (DRBTR). When applying DRBTR, we must, wherever possible, observe the product test before, during and after completion.