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ID:39504491
大小:207.24 KB
页数:14页
时间:2019-07-04
《MHRA Data Integrity Consultation 2016》由会员上传分享,免费在线阅读,更多相关内容在学术论文-天天文库。
1、12MHRAGxPDataIntegrityDefinitionsandGuidanceforIndustry34DraftversionforconsultationJuly201656789Background1011Thewayinwhichregulatorydataisgeneratedhascontinuedtoevolveinlinewiththeintroduction12andongoingdevelopmentofsupportingtechnologies,supplychainsandwaysofworking.Systems13tosuppo
2、rtthesewaysofworkingcanrangefrommanualprocesseswithpaperrecordstotheuseof14computerisedsystems.Howeverthemainpurposeoftheregulatoryrequirementsremainsthesame;15havingconfidenceinthequalityandtheintegrityofthedatageneratedandbeingabletoreconstruct16activitiesremainsafundamentalrequiremen
3、t.171819Introduction:2021Thisdocumentprovidesguidanceonthedataintegrityexpectationsthatshouldbeconsideredby122organisationsinvolvedinallaspectsofthechemicalandpharmaceuticaldevelopmentlifecycle.2324Thisguidanceshouldbereadinconjunctionwiththeapplicableregulationsandthegeneralguidance25s
4、pecifictoeachGxP.WhereGxP-specificreferencesaremadewithinthisdocument(e.g.ICHQ9),26considerationoftheprinciplesofthesedocumentsmayprovideguidanceandfurtherinformation.2728Arrangementsinplacewithinanorganisationwithrespecttopeople,systemsandfacilitiesshouldbe29designed,operatedandwhereap
5、propriateadaptedtosupportaworkingenvironmentand30organisationalculturethatensuresdataiscompleteconsistentandaccurateinallitsforms,i.e.paper31andelectronic.Theeffortandresourceappliedtoassurethevalidityandintegrityofthedatashould32becommensuratewiththeriskandimpactofadataintegrityfailure
6、tothepatientorenvironment.33Whentakencollectivelythesearrangementsfulfiltheconceptofdatagovernance.3435Organisationsarenotexpectedtoimplementaforensicapproachtodatacheckingonaroutinebasis,36butinsteaddesignandoperateafullydocumentedsystemthatprovidesanacceptablestateof37controlbasedonth
7、edataintegrityriskwithsupportingrationale.Inadditiontoroutinedatareview,the38widerdatagovernancesystemshouldensurethatperiodicauditsarecapableofdetecting39opportunitiesfordataintegrityfailureswithinthecompany’ssystem,e.g.routinedatareviewshould40considertheintegrityofanindividu
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