DOXPUB 09-0254-SOP PDF

Summary:

Describes a procedure for responding to customer complaints on products distributed for third parties. Applicable to complaints expressed by clinical investigators, customers and employees, during use of the products, are reported using this procedure. Covers the definition of a complaint, complaint initiation, evaluation, investigation and reporting.

Included Sections:

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

Included Attachments/Appendices:

Complaint Form, Customer Complaint Log On Third Party Products

About This Document:

This is not a generic template, it's a 5-page procedure that was actually created and used in the Quality Assurance 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:

• Quality Assurance Managers
• Clinical Research Managers
• Regulatory Affairs Managers