制药行业PLM解决方案白皮书

PLMOracle20081PLM..................................................................................................................................................3..................................................................................................................................................3.......................................................................................................................................4PLM..........................................................................................................7...........................................................................................................................8...........................................................................................................9.....................................................................................................10.....................................................................................................................10.........................................................................................................................11.........................................................................................11.................................................................................................................................11.....................................................................................................................12................................................................................................................................................12(PLM)OraclePLMPLMOraclePLMOracleAgileR&DAgilezzzzzzzz1Agile81015215PhRMATuffs1995zzzzzz3zzzR&DzzzzzzOraclePLMPLMAgilePLM270PLMAgile()Agile1zzz2zzzz3zzzz4zzz5zz(CMO)(CPO)z(GoodManufacturingPractice)z6z(SOP)(QA)zz(CAPA)7zzzUK-92480(Viagra)(U.S.Hatch-WaxmanAct)FDA5350CROAgileAgileR&DMBR(masterbatchrecord)MBRMicrosoftWordAdobePDFAgileMBRMBRSOPMBROracleAgile4(SurveyReflectsGrowingMaturityofCMCOutsourcingPharmTech20028)PDX(ProductDefinitioneXchange)(CRO)CMPCPOPDXPDX(XML)(CFR)2111PDX~40%AgileAgile()Agile(CAPA)AgileCAPACAPAAgileR&DAgileAgile(CFR)21112111Agile11Oracle(U.S.DataManagement)FDAAgileFDA(CFR2111)AgileFDAOracleFDAFDAOracleOracleFDAOracleOracleAgile(AgileFoodandDrugAdministrationValidationPack)FDAzzzzzzAgilePLMAgileAgileAgileAMRPLMKevinOMarahOracleAgileProductLifecycleManagementinthePharmaceuticalIndustryUpdatedJanuary2008OracleCorporationWorldHeadquarters500OracleParkwayRedwoodShores,CA94065U.S.A.WorldwideInquiries:Phone:[phone]Fax:[phone]oracle.comCopyright©2003,2008,OracleCorporationand/oritsaffiliates.Allrightsreserved.Thisdocumentisprovidedforinformationpurposesonlyandthecontentshereofaresubjecttochangewithoutnotice.Thisdocumentisnotwarrantedtobeerror-free,norsubjecttoanyotherwarrantiesorconditions,whetherexpressedorallyorimpliedinlaw,includingimpliedwarrantiesandconditionsofmerchantabilityorfitnessforaparticularpurpose.Wespecificallydisclaimanyliabilitywithrespecttothisdocumentandnocontractualobligationsareformedeitherdirectlyorindirectlybythisdocument.Thisdocumentmaynotbereproducedortransmittedinanyformorbyanymeans,electronicormechanical,foranypurpose,withoutourpriorwrittenpermission.OracleisaregisteredtrademarkofOracleCorporationand/oritsaffiliates.Othernamesmaybetrademarksoftheirrespectiveowners.