Description
Summary:
Describes the procedure for maintaining the controlled external document file. Includes provisions for international and domestic regulations and standards applicable to product design, quality systems, manufacturing operations, and compliance with ISO 9001.
Included Sections:
Purpose, Scope, Responsibility, References and Applicable Documents, Materials and Equipment, Health and Safety Considerations, Documentation Requirements, and Procedures
Included Attachments/Appendices:
None
About This Document:
This is not a generic template, it's a 2-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
Product Details
- Edition:
- 1.0
- Published:
- 08/01/2007
- Number of Pages:
- 2
- File Size:
- 1 file , 270 KB
