DOXPUB 12-0015-SOP

Summary:

Establishes the standardized style, format and content requirements for Qualification and Validation Document (QVD) protocols and reports. Applicable to any Qualification and Validation Document (QVD) protocols and reports. Includes style definitions, section describes, attchment handling instructions and examples of cover pages, table of contents, and data recording form attachment.

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 10-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
• Quality Assurance Managers
• Validation Technicians