摘要:提供了一个程序，用于鉴定分子设备公司ThermoMax读卡器上的动态定量内毒素分析的分析员和试剂。该程序旨在用于鉴定分子设备ThermoMax读卡器上的动态定量内毒素分析的分析员和试剂。包括仪器设置、模板设置、标准制备、微孔板制备、裂解液制备和接种，以及解释结果。包括的章节:目的、范围、责任、参考和适用文件、材料和设备、健康和安全注意事项、文件要求和程序包括附件/附录: 关于本文件:这不是一个通用模板，它是一个5页的程序，实际上是在FDA监管机构的质量控制操作中创建和使用的。公司特定信息（名称、地址、一些图片、专有产品信息等）已被编辑，但内容和格式已基本保留。购买理由:将其作为你自己文档项目的起点，将你文档的质量与你所在行业的同行进行比较，了解你所在行业的其他公司在做什么，哪些公司会从中受益: 质量保证经理制造经理质量控制人员

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 ProceduresIncluded Attachments/Appendices:NoneAbout 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 projectCompare the quality of your documents against your industry peersLearn what other companies in your industry are actually doingWho Will Benefit:Quality Assurance ManagersManufacturing ManagersQuality Control Personnel