PCS-DQ-VP-001 - 设计确认方案-A1

Validation编号:No.PCS-DQ-VP-001-A1设计确认DesignQualification页码:Page1of14******************（Longfengtang）ComputerizedSystemValidation设计确认DesignQualificationPlan编制角色AuthorizedRole部门Department签名Signature签名日期Date编制人Draftedby天甘科技审核人Reviewedby车间主任制造部部长设备主管IT主管验证管理员QA主管批准人Approvedby质量管理部部长颁发部门：IssuedDepartment质量管理部QualityManagementDept执行日期：Executiondate分发部门：DistributionDepartment版本号：VersionNo.A1修订历史RevisionHistory版本号VersionNo.更新日期UpdatedDate修订作者Author主要修订摘要AbstractValidation编号:No.PCS-DQ-VP-001-A1设计确认DesignQualification页码:Page2of14A1批准版ApproveValidation编号:No.PCS-DQ-VP-001-A1设计确认DesignQualification页码:Page3of14目录TableofContents1目的Purposes...................................................................................................................................42缩略语Abbreviations......................................................................................................................43培训Training...................................................................................................................................44测试说明和接受标准TestInstruction&AcceptanceCriteria...................................................45参考文件Reference.........................................................................................................................56方案前提条件ProtocolPre-Requisites..........................................................................................57测试总览TestOverview.................................................................................................................87.1系统范围TestScriptNo.1–SiteWide....................................................................................97.2编写Preparedby........................................................................................................................97.3测试完成TestCompletion........................................................................................................97.4测试签名登记TesterSignatureRegister..................................................................................97.5前提条件Pre-Requisites..........................................................................................................107.6意见（签名/日期）Comments(Initial/Date)..........................................................................14Validation编号:No.PCS-DQ-VP-001-A1设计确认DesignQualification页码:Page4of141目的Purposes本方案详细描述了******提取1号车间PCS系统设计确认的活动和文档。ThisprotocolspecifiesthedesignqualificationactivitiesanddocumentationrequiredforPCSsystemofChinesemedicineextractionworkshop.2缩略语Abbreviations缩略语Abbreviations描述DescriptionDQ设计确认DesignQualificationIQ安装确认InstallationQualificationOQ运行确认OperationalQualificationTRS技术需求说明TechnicalRequirementSpecificationDCS离散控制系统DistributedcontrolsystemRA风险评估RiskAssessmentVP验证计划ValidationPlanERES电子记录和电子签名ElectricalRecordandElectricalsignatureQPP质量和项目管理计划QualityandProjectManagementPlan3培训Training在测试执行前，测试人员以及供应商的支持测试人员都应该经过培训。Tester/sandvendor/ssupportingtestexecutionshallbetrainedonbasicsystemoperationandthisprotocolpriortotestexecution.4测试说明和接受标准TestInstruction&AcceptanceCriteriaDQ的测试范围如测试总览所列。包含了DQ交付物的确认。测试完成后允许系统放行到下一步项目阶段。详细的测试说明已经在各自的测试脚本内显示。测试脚本中的所有测试步骤都应该完成。AnoverviewofDQtestscopeislistedinTestOverview.ItcoversverificationofDQdeliverables.Thisallowsthereleaseofsystembyprocessareatosubsequentprojectphaseupontestcompletion.Detailedtestinstructionsareprovidedintherespectivetestscripts.Allteststepsinthetestscriptshallbecompleted.在测试执行中生成的所有的附件应该规范标记（附件号，方案文件号，页码和签名/日期）Allattachmentsgeneratedduringtestexecutionshallbeproperlylabeled(withattachmentnumber,protocoldocumentnumber,paginationandinitial/date)andrecordedintheattachmentlog.如下表示附件号：Attachmentnumbershallbedenotedasfollows:测试脚本号-步骤-Attxx（xx表示该步骤的附件顺序号）Validation编号:No.PCS-DQ-VP-001-A1设计确认DesignQualification页码:Page5of14Testscriptnumber-Step#-Attxx(wherexxdenotesrunningsequentialnumberofaspecificstep)例如Examples:主文件：1-Att01ForMainprotocol:1-Att01测试脚本：TS01-1-Att01ForTestscript:TS01-1-Att01测试完成后，执行的测试脚本应该由主题专家和项目经理来审核其完整性和技术的合规性Upontestcompletion,eachexecutedtestscriptshallbereviewedbySMEandPMforcompletenessandtechnicalcompliance.验证QA根据测试脚本的审核结果及相关偏差的处理结果对此验证文件进行批准、放行。ThereleaseofsystemshallbeapprovedbyQAvalidationinTestOverviewbasedonthereviewedtestscriptandanyoutstandingdeviation5参考文件Reference文件编号DocumentID文件名称DocumentnamePCS-QPP-001质量和项目管理计划QualityandProjectManagementplanPCS-DMP-001文档管理规程DocumentManagementProcedurePCS-TRS-001技术需求规范TechnoicalRequirementsSpecificationPCS-ERES-001电子记录和电子签名ElectricalRecordandElectricalSignaturePCS-RA-001风险评估RiskAssessment6-00001验证管理规程ValidationManagementProcedure7-00001计算机化系统管理规程ComputerizedSystemManagementProcedure6方案前提条件ProtocolPre-Requisites在脚本测试执行前，前提条件必须满足Pre-requisitesmustbemetpriortotestscriptsexecution.编号ItemNo.描述Description确认？（是/否）Conformed?(Yes/No)签名/日期Initial/DateValidation编号:No.PCS-DQ-VP-001-A1设计确认DesignQualification页码:Page6of14编号ItemNo.描述Description确认？（是/否）Conformed?(Yes/No)签名/日期Initial/Date1确认TRSVerificationTRS已经批准TRSVerifythatTRShasbeenapproved.记录文件名称，版本和批准日期Recordthedocumentreference,revisionandapprovaldate