DOXPUB 09-0068-SOP

Summary:

Provides aprocedure for qualifying analysts and reagents for kinetic quantitative endotoxin assays on the ThermoMax reader from Molecular Devices, Inc. Intended to be used for qualifying analysts and reagents for kinetic quantitative endotoxin assays on the ThermoMax reader from Molecular Devices. Covers instrument setup, template setup, standard preparation, microplate preparation, lysate preparation and inoculation, and interpreting results.

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 5-page procedure that was actually created and used in the Quality 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:

• Quality Assurance Managers
• Manufacturing Managers
• Quality Control Personnel