PDA-数据完整性行为守则要素

ParenteralDrugAssociationPointstoConsider□□□□□□□□□ElementsofaCodeofConductforDataIntegrity□□□□□□□□□□□Introduction□□DataIntegrityhasbeenandcurrentlyisamajorglobalconcernofHealthAuthoritiesandthepharmaceuticalindustry.Althoughnotanewissue,numerousrecentHealthAuthorityenforcementactionssuchasWarningLetters,ImportAlerts,ProductDetentions,andsuspensionorrevocationofMarketingAuthorizationshasfocusedattentiononDataIntegrity.DataIntegritycanresultfromlackofawarenessofregulatoryrequirements,employeeerrors,failuretocheckaccuracyofdata,softwareorsystemmalfunction,orconfigurationproblemswithelectronicdatahandling,ormalfeasancebyemployees.ToholisticallyaddressDataIntegrity,theParenteralDrugAssociation(PDA)isdevelopingasetoftoolsintheformofPDATechnicalReports,PDATrainingProgram,DataIntegrityWorkshops,andPointstoConsiderdocumentsthatcanbeusedbyindustrytoaddressthisseriousissue.ThisdocumentpresentstheviewsoftheParenteralDrugAssociation(PDA)onthebenefitsforcompaniestovoluntarilyadoptaCodeofConductforassuringdataintegrity.□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□(PDA)□□□□□□□□□□□□□PDA□□□□□PDA□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□(PDA)□□□□□□□□□□□□□□□□□□□□□□□□HowtoUsethisDocument□□□□□□□Thisdocumentwasdevelopedbyateamwithexpertiseinthefieldsofquality,regulatoryaffairs,auditing,andmanufacturingandreviewedbyattorneysspecializedinfood,drugandlaborlaw.Thisdocumentiswrittenforeasyadoption,inpartorinitsentirety,bycompanies,iftheysochoose,withouttheneedforextensiverewritingofthedocument.Therefore,theterms□shallUand□mustDhavebeenusedtopermittheCodetobeenfor...