Periodic Reviews of Computerized Systems文档格式.docx
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Periodic Reviews of Computerized Systems文档格式.docx
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Someoftheinterpretationsofthisclauseare
∙Youhavetoconductperiodicreviewsofcomputerizedsystems.
∙Therearenoexceptionstothisregulation(forexample,onlycriticalsystemsneedtobeevaluated);
allsystemsmustbereviewed.
∙Thefrequencyofthereviewisdeterminedbythecompany'
squalityassuranceorlaboratorymanagementandjustifiedwherenecessarytoaninspector.Implicitinthisstatementisthatyoushouldapplyariskassessmenttodeterminethefrequency.Also,itisexplicitlystatedinclause1ofAnnex11thatriskassessmentisconductedthroughoutthelifecycleofacomputerizedsystem.
∙Theaimofanyreviewistoensurethatthesystemiscompliantwiththeapplicableregulationsandthatitremainsinavalidatedstateoverthetimeperiodsincethelastreview.
∙Thescopeoftheperiodicreviewcancoverthelastfullvalidation,changecontrolrecordssincethelastvalidation,problemsandtheirresolution,useraccountmanagement,usertraining,andITsupportsuchasdatabackup.
Whatisnotstatedintheregulationhowever,istheformalityoftheprocess.Sohowcanwedemonstratetoaninspectorthatperiodicreviewshavebeencarriedout?
Unlessthereviewsareformallydocumented,thenyoucan'
t;
it'
sassimpleasthat.Sowewilllookattheoverallprocessofaperiodicreviewinthiscolumnandtheninthenextinstallmentwewillexaminethepracticalitiesofperformingandreportingsuchareview.
ASmallRegulatoryProblem
Whyperformaperiodicreview?
Thisisprobablyonequestionthatyoumayaskwhenreadingthesectionabove.Inlife,itisalwaysbettertouserealexamplestoillustratepointsyouaretryingtomakebecauseitdemonstratesthatotherorganizationscansometimesmakebiggermistakesthanyoudo.Take,forexample,thefollowingcitationfromaFoodandDrugAdministration(FDA)warningletter(3):
6.Yourfirmfailedtochecktheaccuracyoftheinputtoandoutputfromthecomputerorrelatedsystemsofformulasorotherrecordsordataandestablishthedegreeandfrequencyofinput/outputverifications[21CFR§
211.68(b)].
Forexample,theperformancequalificationofyour<
redacted>
systemsoftwarefailedtoincludeverificationoftheexpirationdatecalculationsinthe<
system.Inaddition,thereisnoestablisheddegreeandfrequencyofperformingtheverification.Discrepancyreportshavedocumentedthatproductlabelingwithincorrectexpirationdateshavebeencreatedandissuedforuse.
YourresponsestatesthatyouopenedInvestigationT-139andyouprovideaJanuary29,2010throughFebruary26,2010completiontimeline.Youhavenotprovidedaresponsetocorrectthisviolationandestablishacorrectiveactionplantoassurethatcomputersystemsareproperlyqualified.
Thepointisthattheinitialvalidationfailedtocheckcalculationsinacomputersystemresultingindruglabelsthatwereprintedwithincorrectexpirydatesonthem.Whopickedupontheproblem?
Theinspector!
Ifthecompanyhadconductedaperiodicreview,thisproblemshouldhavebeenidentifiedbythereviewer,sinceitisanexplicitrequirementoftheUSGMPregulations,asnotedinthewarningletter.Itisanobviouspointforpotentialproblemswithanycomputerizedsystemandtheissueshouldhavebeenidentifiedandresolvedlongbeforetheinspectorstrolledthroughthedoorforteaandcookies.
What'
sinaName?
AlthoughtheAnnex11regulationtalksaboutaperiodicevaluation(Ihavecalleditaperiodicreview),therearealsolaboratoryauditscarriedoutbythequalityassurancedepartments.Soareperiodicevaluations,periodicreviews,orauditsthesame,oraretheydifferent?
Inmyopinion,periodicreviewsorperiodicevaluationsareoneandthesame,andarefocussedonacomputerizedsystem,theprocessitautomates,andthesupportprocessesforit.Incontrast,anauditcancoveracomputerizedsystem,alaboratoryprocess,qualitysystem,orasubsetofanyportionofthelaboratory.Therefore,anauditcanbethesameasaperiodicrevieworevaluation,butcanalsobeawidercheckoflaboratoryoperationstoensurecompliancewithregulationsandinternalprocedures.Anauditalsocancovercomputerizedsystemsthatarepartoftheprocess,butgenerallythescopeofanauditiswiderthanaperiodicreview.Therefore,lookedatfromanotherperspective,periodicreviewsareasubsetoflaboratoryaudits.Thus,inthiscolumnIwillreferonlytoperiodicreviewsbutthiswillincludeperiodicevaluationandgeneralauditsthatincludecomputerizedsystems.
OverviewofaPeriodicReview
ThetopicofaperiodicreviewthatwewilldiscussisshowninFigure1andconsistsoftwophases:
planningandexecution.
Figure1:
Flowchartforaperiodicrevieworauditofacomputerizedsystem.
Sowehaveestablishedthattheperiodicreviewisanindependentauditofacomputerizedsystemtodetermineifthesystemhasmaintaineditsvalidationstatusand,assaidbefore,itisalsoaplannedandformalactivity.Thefirstrequirementforconductingareviewisastandardoperatingprocedure(SOP)coveringthewholeprocess.Asaperiodicreviewisasubsetofanaudit,theauditSOPshouldberelativelysimpletoadoptforacomputerizedsystemoryoucanuseanexistingauditSOPwithasubsectionforperiodicreviews.Thewholeprocessshouldbedescribedintheaudit/reviewSOPandisshowninFigure1.
Ihavedepictedtheprocessastwoparts:
∙Theplanningphase(coveringallsystems).Thislinkstheinventoryofcomputerizedsystemsforthelaboratorywithariskclassificationofeachsystem(thefiguresuggestscritical,major,orminor,butthisisonlyasuggestion)totheSOPforperiodicreviewsandauditsandtheannualself-inspectionschedule.Theprincipleisthatthecriticalsystemsarereviewedmorefrequentlythanmajororminorsystems,andmajorsystemsarereviewedmorefrequentlythanminorones.Theperiodicityofreviewforeachtypeofsystemisdeterminedbyyourcompany.
∙Theexecutionphase(foreachsystemreviewed).Foreachsystemselectedforreviewthereisacommonprocessthatconsistsofplanningandpreparationforthereview,theopeningmeeting,performingtheaudit,includingacheckontheeffectivenessofcorrectiveactionsfromapreviousreview,thereviewer'
sclosedmeetingwheretheobservationsareexaminedtodetermineifthereareanyfindingsornoncompliances,theclosingmeetingwherefindingsandobservationsarediscussed,andfinallythewritingofthereviewreportandanactionplanforanycorrectiveactionsorpreventativeactions.
Inthisinstallment,wewillfocusmostlyontheplanningphaseandwillpresenttheexecutionphaseinanoverview.Thenextinstallmentwillcovertheexecutionphaseinmoredetail.
ObjectivesofaPeriodicReview
Thereshouldbetwomaingoalsforaperiodicreviewofacomputerizedsystem:
∙Toprovideindependentassurancetotheprocessownerandseniormanagementthatcontrolsareinplacearoundthesystembeingreviewedandarefunctioningcorrectly.Thesystemisvalidatedandcontrolsareworkingadequatelytomaintainthevalidationstatus.
∙Toidentifythosecontrolsthatarenotworkingandtohelptheprocessownerandseniormanagementimprovethemandthuseliminatetheidentifiedweaknesses.Theimpactofafindingmaybeapplicabletoasinglecomputerizedlaboratorysystemorallsystemsinalaboratory.
Itisthesecondobjectivethatisthemostimportant,inmyview.Moreover,itisanimportantoutcomefromanyperiodicreviewforseniormanagementtorealizethatsomecontrolsmayrequiresystematicresolution.Ifaproblemisfoundinaprocedurethatisusedforallsystems,theresolutionofthismayaffectallcomputerizedsystemsusedinthelaboratoryratherthanjusttheonebeingreviewed.
WhoPerformsaPeriodicReview?
Annex11doesnotsaywhoshouldcarryouttheperiodicreview.Solet'
sconsiderthepossibilities:
∙Theprocessowner(thelaboratorypersonwhoisresponsibleforthesystem)
∙Thesystemowner(thepersonresponsiblefortheavailabilityandsupportofthesystem)
∙Qualityassurance(QA)
Hmmm,Icanguesssomeofyouranswers.ThepointIwanttomakeisthatpeopledirectlyinvolvedwithacomputerizedsystemhaveavestedinterestintheirsystemandcannotmakeanobjectivedecisionifanactivityisundercontrolandincomplianceornot.QAmaybeappropriatetoconductaperiodicreview,buttheindividualshavetoknowaboutcomputerizedsystemvalidationandunderstandtheregulationsandcompanyproceduresinrelationtocomputerizedsystems;
notmanyinQAfitthesecriteria.
Sotohelpusanswerthequestion,whatdotheregulationssayaboutthis?
EuropeanUnion
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