MHRA数据完整性指南-2018(中英文)

MHRAGXPDataIntegrityGuidanceandDefinitions;Revision1:March2018Medicines&HealthcareproductsRegulatoryAgency(MHRA)‘GXP’DataIntegrityGuidanceandDefinitionsGXP数据完整性指南和定义March2018MHRAGXPDataIntegrityGuidanceandDefinitions;Revision1:March2018目录1.Background背景....................................................................................................................32.Introduction概述....................................................................................................................33.Theprinciplesofdataintegrity数据完整性原则......................................................................44.Establishingdatacriticalityandinherentintegrityrisk建立数据关键性和内在完整性风险.......55.Designingsystemsandprocessestoassuredataintegrity;creatingthe‘rightenvironment’.设计系统和流程确保数据完整性，创建“正确环境”............................................76.Definitionoftermsandinterpretationofrequirements术语定义和要求诠释............................86.1.Data数据.....................................................................................................................86.2.Rawdata(synonymouswith‘sourcedata’whichisdefinedinICHGCP)原始数据（与ICHGCP中定义的“源数据”为同义词）........................................................................96.3.Metadata元数据........................................................................................................106.4.DataIntegrity数据完整性...........................................................................................106.5.DataGovernance数据管理........................................................................................106.6.DataLifecycle数据生命周期......................................................................................116.7.Recordingandcollectionofdata数据记录和采集......................................................116.8.Datatransfer/migration数据转移/迁移......................................................................126.9.DataProcessing数据处理.........................................................................................126.10.ExcludingData(notapplicabletoGPvP):除外数据（不适用于GPvP）.....................136.11.Originalrecordandtruecopy原始记录和真实副本....................................................136.11.1.Originalrecord原始记录..............................................................................................136.11.2.Truecopy真实副本......................................................................................................146.12.Computerisedsystemtransactions:计算机化系统处理..............................................156.13.AuditTrail审计追踪...................................................................................................156.14.Electronicsignatures电子签名...................................................................................176.15.Datareviewandapproval数据审核和批准.................................................................186.16.Computerisedsystemuseraccess/systemadministratorroles计算机化系统用户权限/系统管理员角色.........................................................................................................196.17.Dataretention数据保存.............................................................................................206.17.1.Archive归档..............................................................................................................206.17.2.Backup备份..............................................................................................................216.18.Filestructure文件结构...............................................................................................216.19.Validation–forintendedpurpose(GMP;SeealsoAnnex11,15)根据既定用途进行验证（参见附录15和GAMP5）...................................................................................226.20.ITSuppliersandServiceProviders(includingCloudprovidersandvirtualservice/platforms(alsoreferredtoassoftwareasaserviceSaaS/platformasaservice(PaaS)/infrastructureasaservice(IaaS)).IT供应商和服务提供商（包括云服务提供商和虚拟服务/平台（也请参见SAAS/PAAS/IAAS））..............................................227.Glossary术语.......................................................................................................................248.References参考文献...........................................................................................................25MHRAGXPDataIntegrityGuidanceandDefinitions;Revision1:March20181.Background背景Thewayregulatorydataisgeneratedhascontinuedtoevolveinlinewiththeongoingdevelopmentofsupportingtechnologiessuchastheincreasinguseofelectronicdatacapture,automationofsystemsanduseofremotetechnologies;andtheincreasedcomplexityofsupplychainsandwaysofworking,forexample,viathirdpartyserviceproviders.Systemstosupportthesewaysofworkingcanrangefrommanualprocesseswithpaperrecordstotheuseoffullycomputerisedsystems.Themainpurposeoftheregulatoryrequirementsremainsthesame,i.e.havingconfidenceinthequalityandtheintegrityofthedatagenerated(toensurepatientsafetyandqualityofproducts)andbeingabletoreconstructactivities.随着支持性技术的持续发展，法规数据的生成方式也在继续进化，例如越来越多地使用电子签名捕获、系统自动化和使用远程技术；以及供应链复杂性和工作方式复杂性的增加，例如，通过第三方服务商提供服务。支持这些工作方式的系统可能包括有从手动处理