![]() ![]() (d) Packaging and labeling specifications, including methods and processes used and (c) Quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment to be used (b) Production process specifications including the appropriate equipment specifications, production methods, production procedures, and production environment specifications ![]() (a) Device specifications including appropriate drawings, composition, formulation, component specifications, and software specifications The following contents are listed in the relevant chapter of the CFR as part of the Device Master Record: Labels, Instructions for Use, drawings, Certificates of Conformity, and other documents might form part of a DMR. The physical appearance of the DMR can be a binder with documents, a document that can refer to other documents, or the same concepts in a computer as documents in a database. The term is used in Quality Management Systems that cover product design and production. A Device Master Record ( DMR) is a compilation of all the instructions, drawings and other records that must be used to produce a product.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |