Full Description

This document describes a paper-based process for controlling GxP documents throughout their entire lifecycle. Includes instructions for creating, reviewing, and approving documents, as well as numbering, filing, distribution and archiving. Also includes the following attachments: Document Flow Chart, Document Number Scheme, Draft Document Review Matrix, Document Approval Matrix, Document Change Request form, Materials Control Review form, Document Change Order form, Document Archiving and Distribution form, Regulatory Assessment Review form, and Annual Document Review form. This SOP is used in conjunction with the Document Change Request Form, 09-0001-FRM-1.0.

Product Details:

Edition: 1.0 Published: 08/01/2004 Number of Pages: 28