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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.
Commissioning (construction) In construction, commissioning or commissioning process (often abbreviated Cx) [1][2][3] is an integrated, systematic process to ensure, that all building systems perform interactively according to the "Design Intent", through documented verification. The commissioning process establishes and documents the "Owner's ...
A design review is a milestone within a product development process whereby a design is evaluated against its requirements in order to verify the outcomes of previous activities and identify issues before committing to—and, if need be, to re-prioritise—further work. [1] The ultimate design review, if successful, therefore triggers the ...
DO-254. RTCA DO-254 / EUROCAE ED-80, Design Assurance Guidance for Airborne Electronic Hardware is a document providing guidance for the development of airborne electronic hardware, published by RTCA, Incorporated and EUROCAE. The DO-254/ED-80 standard was formally recognized by the FAA in 2005 via AC 20-152 as a means of compliance for the ...
A standard operating procedure (SOP) is a set of step-by-step instructions compiled by an organization to help workers carry out routine operations. [1] SOPs aim to achieve efficiency, quality output, and uniformity of performance, while reducing miscommunication and failure to comply with industry regulations. [citation needed]
The general standard IEC 60601-1 – Medical electrical equipment – Part 1: General requirements for basic safety and essential performance – gives general requirements of the series of standards. 60601 is a widely accepted benchmark for medical electrical equipment and compliance with IEC60601-1 has become a requirement for the commercialisation of electrical medical equipment in many ...
In power engineering, a single-line diagram (SLD), also sometimes called one-line diagram, is a simplest symbolic representation of an electric power system. [1][2] A single line in the diagram typically corresponds to more than one physical conductor: in a direct current system the line includes the supply and return paths, in a three-phase ...
Front-end loading (FEL), also referred to as Front End Planning (FEP), pre-project planning (PPP), feasibility analysis, conceptual planning, programming/schematic design and early project planning, is the process for conceptual development of projects in processing industries such as upstream oil and gas, petrochemical, natural gas refining, extractive metallurgy, waste-to-energy ...