概述:描述了FDA监管机构的纸质受控文件和记录管理系统的政策和程序。适用于产品开发和制造、临床研究、质量体系和监管活动中的文件和记录。包括审查、修订、纠正、批准、发布、分发、存储、使用和处置受控文件的规定。包括的章节:目的、范围、责任、参考文件和适用文件、定义、政策、主要程序步骤概述、程序、附件/附录包括的附件/附录:文件格式标准、文件标识号和版本标识符格式、文件服务器目录结构、良好的文件实践、，关于此文档的文档分发矩阵: 这不是一个通用模板，它是一个11页的程序，实际上是在FDA监管机构的文件控制操作中创建和使用的。公司特定信息（名称、地址、一些图片、专有产品信息等）已被编辑，但内容和格式已基本保留。购买理由:将其作为你自己文档项目的起点，将你文档的质量与你所在行业的同行进行比较，了解你所在行业的其他公司在做什么，谁会从中受益:文档控制人员配置管理质量保证经理

Summary:Describes the policies and procedures of a paper-based controlled document and record management system for FDA-regulated establishments. Applies to documents and records that are part of product development and manufacturing, clinical research, quality system and regulatory activities. Includes provisions for reviewing, revising, correcting, approving, publishing, distributing, storing, using and disposing of controlled documents.Included Sections:Purpose, Scope, Responsibility, References and Applicable Documents, Definitions, Policy, Overview of Major Procedure Steps, Procedure, Attachments/AppendicesIncluded Attachments/Appendices:Document Formatting Criteria, Document Identification Number and Version Identifier Formatting, File Server Directory Structure, Good Documentation Practices, Document Distribution MatrixAbout This Document:This is not a generic template, it's a 11-page procedure that was actually created and used in the Document Control operations of a FDA-regulated establishment. The company-specific information (names, addresses, some images, proprietary product information, etc.) has been redacted but the content and format have been largely preserved.Reasons to Buy:Use it as a starting point for your own documentation projectCompare the quality of your documents against your industry peersLearn what other companies in your industry are actually doingWho Will Benefit:Document Control PersonnelConfiguration ManagementQuality Assurance Managers