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QVD Protocol and Report Preparation QVD协议和报告准备
发布日期: 2007-08-01
总结:确定鉴定和验证文件(QVD)协议和报告的标准化风格、格式和内容要求。适用于任何鉴定和验证文件(QVD)协议和报告。包括样式定义、章节描述、附件处理说明和封面示例、目录和数据记录表格附件。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10页的程序,实际上是在一家FDA监管机构的文件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,谁会从中受益:文档控制人员质量保证经理验证技术员
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 ProceduresIncluded Attachments/Appendices:NoneAbout 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 projectCompare the quality of your documents against your industry peersLearn what other companies in your industry are actually doingWho Will Benefit:Document Control PersonnelQuality Assurance ManagersValidation Technicians
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