冷库验证方案(12 页)Good is good, but better carries it.精益求精,善益求善。冷库验证方案部门人员日期编制会审批准目 录一 引言..................................................................................................................................................31.1 概述......................................................................................................................31.2 主要技术参数........................................................................................................3二 验证目的:......................................................................................................................................3三 验证范围:......................................................................................................................................3四 验证程序..........................................................................................................................................44.1 文件资料的确认.....................................................................................................44.2 仪器的确认............................................................................................................44.3 安装确认...............................................................................................................44.4 设备运行确认........................................................................................................44.5 设备性能确认........................................................................................................5五 验证结果分析和评价.....................................................................................................................5六 验证周期..........................................................................................................................................6一 引言1.1 概述冷库安装在仓库,占地面积约 10.5 平方米, 内室容积约 23m3,主要用于需要 2-8℃保存的诊断试剂产...