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/Appendices

Included Attachments/Appendices:

Document Formatting Criteria, Document Identification Number and Version Identifier Formatting, File Server Directory Structure, Good Documentation Practices, Document Distribution Matrix

About 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 project
• Compare the quality of your documents against your industry peers
• Learn what other companies in your industry are actually doing

Who Will Benefit:

• Document Control Personnel
• Configuration Management
• Quality Assurance Managers