DOXPUB 15-0048-SOP

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