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The product data submittal usually consists of the manufacturer's product information. The information included in this submittal are: Manufacturer, trade name, model or type number and quantities: This information is necessary to compare the submitted item with the specified products and acceptable products listed, in the specification and addenda.
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 .
Shop drawings are produced by contractors and suppliers under their contract with the owner. The shop drawing is the manufacturer’s or the contractor’s drawn version of information shown in the construction documents. [ 1] The shop drawing normally shows more detail than the construction documents. It is drawn to explain the fabrication and ...
The Construction Specifications Institute (CSI) is a United States national association of more than 6,000 construction industry professionals who are experts in building construction and the materials used therein. The institute is dedicated to improving the communication of construction information through a diversified membership base of ...
Construction is a general term meaning the art and science of forming objects, systems, or organizations. [ 1] It comes from the Latin word constructio (from com- "together" and struere "to pile up") and Old French construction. [ 2] To 'construct' is a verb: the act of building, and the noun is construction: how something is built or the ...
Construction Products Directive (Council Directive 89/106/EEC) (CPD) is a now repealed European Union Directive which aimed to remove technical barriers to trade in construction products between Member States in the European Union. The directive is now replaced by Regulation (EU) No 305/2011. The directive was replaced in order to simplify and ...
Design review. 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 ...
Specification (technical standard) A specification often refers to a set of documented requirements to be satisfied by a material, design, product, or service. [ 1] A specification is often a type of technical standard . There are different types of technical or engineering specifications (specs), and the term is used differently in different ...