Device Master Record means the compilation of records containing the procedures and Specifications for the Product.
Device Master Record shall have the meaning ascribed in 21 CFR 820.
Device Master Record shall include device specifications, production process specifications, quality assurance procedures and specifications (including acceptance criteria and quality assurance equipment to be used), and packaging and labeling specifications.
Examples of Device Master Record in a sentence
Design output documentation is contained in the Device Master Record (DMR).
In sum, hypothesis 2 was not supported when utilizing the response data sample (n = 8), but was supported when utilizing the generated data set (n = 400).Hypothesis Three: The third hypothesis is: manufacturing flow management practices will be positively related to competitive advantage within an organization.
In 1926, Carter Woodson, considered by many to be the ‘‘Father of Black History,’’ created Negro History Week.
Hence, historical data was obtained from CWD Department to develop an understanding of traffic patterns and to compare available historical traffic data with the current traffic counts.
One of the tiers of documents supporting the quality manual is a " Device Master File" or " Device Master Record" (DMR) for each product type (see 4.4.5).
More Definitions of Device Master Record
Device Master Record means a compilation of records containing the procedures and specifications for designing and manufacturing a finished device, including the design history file for that device.
Device Master Record for a Product means the information required to manufacture such Product, including the bill of materials (excluding material formulations), tooling, test fixtures, process flow documentation, design files, quality inspections and similar materials. The Device Master Record will not include the formulation of any proprietary materials of Parlex, including any inks, adhesives, coating or other materials, used in the manufacture of the Products.
Device Master Record or "DMR" means the compilation of the records containing the procedures and specifications for a Device, Base Unit, Transjector and Chamber. The DMR includes, but is not limited to drawings, CAD files, batch records, manufacturing procedures, test protocols and procedures and inspection protocols and procedures. The DMR may be amended from time to time as provided in Section 3.6.
Device Master Record means the compilation of records that contain the procedures and specifications for a finished medical device, as required by the FDA pursuant to 21 C.F.R. Part 820, including medical device specifications, production process specifications, quality assurance procedures and specifications, packaging and labeling specifications and installation, maintenance and servicing procedures and methods, or the equivalent as required by an FDA Counterpart.
Device Master Record means the master control record prepared by MTIA and Echo for a medical device which shall include, or refer to the location of, the following information: (a) device specifications including appropriate drawings, composition, formulation, component specifications, and software specifications; (b) production process specifications including the appropriate equipment specifications, production methods, production procedures, and production environment specifications; (c) quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment to be used; (d) packaging and labeling specifications, including methods and processes used; and (e) installation, maintenance, and servicing procedures and methods.
Device Master Record. DMR") as used herein shall mean the compilation of records containing the procedures and specifications for a finished device as described by 21 CFR Section 820.3(j) and Section 820.18 1.
Device Master Record means a compilation of records provided to Jabil by Company containing the procedures and specifications for each finished Product, including Specifications, Test Procedures, Packaging and Shipping Specifications, Product design drawings, the Approved Manufacturers’ List, material component descriptions (including approved substitutions) and manufacturing process requirements, as more particularly defined in the Quality Agreement. Device Master Record is wholly owned by Company and Company shall be responsible for the adequacy and sufficiency of the Device Master Record and any procedures or specifications contained therein. Jabil is responsible for maintaining the Device Master Record (Document and Data Control). Any changes to the Device Master Record must be approved by Company before they are implemented.