DOXPUB 12-0005-SOP

Summary:

Describes the procedures for creating a complete and comprehensive record of laboratory work using notebooks. Applicable to bound laboratory notebooks and other records of laboratory activities. Includes general guidelines and provisions for handwritten data entries and notations, data entry organization, attachments, reviewing and countersigning, and confidentiality.

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 3-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
• Intellectual Property Managers
• Research & Development Associates