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General Laboratory Procedures: Quality Assurance (QA) 一般实验室程序:质量保证(QA)
发布日期: 2007-08-01
概述:描述了一种程序,以确保在实验室执行的所有样本接收、处理、免疫染色和解释程序的适当质量保证。还包括每月的质量保证测试和抽样。适用于处理、处理、免疫染色或解释患者标本结果的实验室人员。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的附件/附录:无关于本文件:这不是通用模板,这是一个长达3页的程序,实际上是在一家FDA监管机构的实验室研发运营中创建和使用的。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。购买原因: 把它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:流程开发人员方法开发人员质量控制人员
Summary:Describes a procedure to assure proper quality assurance of all specimen receiving, processing, immunostaining, and interpretation procedures performed in the laboratory. Also covers monthly QA testing and sampling. Applies to laboratory personnel who handle, process, immunostain, or interpret the results of patient specimens.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 3-page procedure that was actually created and used in the Laboratory R&D 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:Process Development PersonnelMethod Development PersonnelQuality Control Personnel
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