*******************公司文件编号**********************公司口服固体项目页码ofNUMPAGES29CleanRoomInstallationQualificationProtocol洁净室安装确认方案CleanRoomInstallationQualificationProtocol洁净室安装确认方案SystemNo.系统编号:CLR-01ApprovalforProtocol方案批准Company/Title公司/职务Name姓名Signature签名Date日期Writtenby起草Reviewedby审核Approvedby批准Revision版本Issueddate颁布日期Reasonfornewissue颁布原因REV.00Initialissue首次发布Index目录TOC\o"1-3"\h\z\uHYPERLINK\l"_Toc369036447"1.Purpose目的PAGEREF_Toc369036447\h3HYPERLINK\l"_Toc369036448"2.Scope范围PAGEREF_Toc369036448\h3HYPERLINK\l"_Toc369036449"3.Responsibility职责PAGEREF_Toc369036449\h3HYPERLINK\l"_Toc369036450"4.RegulationandGuidance法规和指南PAGEREF_Toc369036450\h3HYPERLINK\l"_Toc369036451"5.Abbreviations缩略语PAGEREF_Toc369036451\h4HYPERLINK\l"_Toc369036452"6.SystemDescription系统描述PAGEREF_Toc369036452\h4HYPERLINK\l"_Toc369036453"7.GoodDocumentationPractice文件管理规范PAGEREF_Toc369036453\h5HYPERLINK\l"_Toc369036454"8.TestList测试列表PAGEREF_Toc369036454\h6HYPERLINK\l"_Toc369036455"9.PersonnelIdentification人员确认PAGEREF_Toc369036455\h7HYPERLINK\l"_Toc369036456"10.Procedure过程PAGEREF_Toc369036456\h8HYPERLINK\l"_Toc369036457"10.1先决条件PAGEREF_Toc369036457\h8HYPERLINK\l"_Toc369036458"10.2文件确认PAGEREF_Toc369036458\h10HYPERLINK\l"_Toc369036459"10.3图确认PAGEREF_Toc369036459\h11HYPERLINK\l"_Toc369036460"10.4房间组件检查PAGEREF_Toc369036460\h14HYPERLINK\l"_Toc369036461"10.5仪器仪表校验PAGEREF_Toc369036461\h16HYPERLINK\l"_Toc369036462"10.6洁净室建造装修检查PAGEREF_Toc369036462\h19HYPERLINK\l"_Toc369036463"10.7电器安装检查PAGEREF_Toc369036463\h23HYPERLINK\l"_Toc369036464"11.DeviationReport偏差报告PAGEREF_Toc369036464\h29Purpose目的本安装确认方案的目的是测试、检查和洁净室是按照相应设计要求和供应商的建议进行安装的。安装确认的测试和检查的结果将按照该验证方案进行记录。安装确认将确定直接影响系统的关键部件被正确地安装，并符合设计文件需求；确定支持文件、质量文件在现场。测试和检查的结果将按照该验证方案进行记录。Scope范围本方案确定了***********公司口服固体项目车间的洁净室（位号：***********）的安装确认。Responsibility职责RegulationandGuidance法