Description
Summary:
Describes a guideline for Development Reports created by Research and Development, or Engineering, prior to transfer of the product/process to manufacturing. Includes a development report table of contents and provisions for compliance with 21 CFR Part 820 and 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:
Development Report Template
About This Document:
This is not a generic template, it's a 4-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
- Engineering Research & Development Personnel
- Quality Assurance Managers
Product Details
- Edition:
- 1.0
- Published:
- 08/01/2007
- Number of Pages:
- 4
- File Size:
- 1 file , 300 KB
