Risk-based_Approach_to_Validation

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1、Risk-basedApproachtoValidationDevoraPerichGriecoManager,Quality&ComplianceTheClassicandRisk-basedApproachesTheFDAdefinesvalidationas“establishingdocumentedevidencethatprovidesahighdegreeofassurancethataspecificprocesswillconsistentlyproduceaproductmeetingit

2、spredeterminedspecificationsandqualityattributes.”Thephrase“highdegreeofassurance”enablescompaniestodetermineforthemselvestheManyappropriateleveloftestingforthesystembeingimplemented.organizationsTheclassicapproachtovalidationinvolvestestingeachsystemrequir

3、ementinthesamecomprehensivemannerwithouttakingusingarisk-basedintoaccounthowmuchriskafailureofthefunctionwouldaddtoapproachtothepatient.Allfunctionsarecomprehensivelytested,whichmayresultintestingofpositiveandnegativescenariostoensureallvalidationfailtogofa

4、ultpointsareequallyandexhaustivelytested.Thisapproachthroughalloftheensuresthateveryrequirementisthoroughlytested,butitcancauseunnecessarydelaysinthereleaseofcriticalsystems,andsteps,thusassuch,mayactuallyincreasetherisktoapatient’shealth.increasingtimeandI

5、nrecentyears,companieshavebegunmovingfromthiscostinsteadofclassic,all-encompassingvalidationstrategytoamoretargetedreducingeffort.methodologybasedonrisk.GoodAutomatedManufacturingProcesses(GAMP)5seekstoupdatetheindustry’sthinkingregardingvalidationresourcin

6、gandtheappropriatewaytoallocateresourcestogetasystemreleased.Afunctionalriskassessmentisawaytoanalyzeasystemanddeterminetherisklevelsofindividualfunctionssothattestingcanbeappropriatelyscaledtotherisk.Thiscontrastswiththeclassicapproachwhere,bynotassessingt

7、herisklevelsofeachfunction,oneisinessenceassigningallrequirementsthesamerisklevelof“High.”2Figure1comparestheclassicapproachtovalidationtotherisk-basedapproach.ClassicApproachRisk-basedApproach1.Defineallrequirements.1.Defineallrequirements.2.Choosesystemto

8、meetallrequirements.2.Choosesystemtomeetallrequirements.3.Performvendorauditorassessment.Vendor3.Performvendorauditorassessmenttogainahasabusinessinterestincreatingaqualitysys-highlevelofconfidenceinth