DOXPUB 09-0011-SOP

Summary:

Describes how responds to a complaint, such as those expressed by clinical investigators, customers and employees during use of the product. Applies to all finished goods. Covers definitions of complaints, sources of complaints, initiation of complaint forms, review of complaint forms, investigation and documentation of complaints, trending, MRB review, follow up actions, close out of the complaint actions, vendor communication, and documentation.

Included Sections:

Purpose, Scope, Responsibility, References and Applicable Documents, Materials and Equipment, Health and Safety Considerations, Documentation Requirements, and Procedures

Included Attachments/Appendices:

Workflow Diagram of Complaint Handling Procedure, Customer Action Report (Car) Form, Car Evaluation Form, Car Closure Form, Car Investigation Form, and Car Log.

About This Document:

This is not a generic template, it's a 14-page procedure that was actually created and used in the Regulatory Affairs 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:

• Regulatory Affairs Managers
• Quality Assurance Managers
• Manufacturing Managers