EmpowerEnterprise验证方案.docx
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EmpowerEnterprise验证方案
EmpowerSystemsQTforSoftware
ThisprotocoldocumentdescribestheprocessforperformingtheInstallationQualification(IQ)andOperationalQualification(OQ)forWaters®Empower
SystemsQT™forSoftware,withorwithoutMethodValidationManager(MVM)software.
Evaluatebeforequalificationbegins
Theowner'smanagementmustreviewthisprotocol,theEmpowerSystemsQTforSoftwarereleasenotes(partnumber716003298),theWatersQualificationOverview(partnumber715511111),andEmpower3softwarereleasenotes:
•Empower3(base)ReleaseNotes(partnumber715002704)
•ServiceRelease1ReleaseNotes(partnumber716003450)
Toperformthequalification,youmustberunningEmpower3FeatureRelease1,minimum.
•FeatureRelease1ReleaseNotes(partnumber716003561)
•FeatureRelease2ReleaseNotes(partnumber716003923)
•FeatureRelease3ReleaseNotes(partnumber716004689)
Identifythescope:
•Personal,Workgroup,orEnterpriseConsiderationsforIQorOQexecution:
•ExecutionfortheCitrix®serverrequiresittobelistedasanode.IftheCitrixserverisnotlistedasanode,logintotheCitrixserverandlaunchEmpower.InNodes,createanewnodeusingtheexactnameoftheCitrixserver.
•Ensurecomputerconnectiontoaprinter,howevereachnodedoesnotrequireprinteraccess.
•EnabletheRunEmpowerSQTprivilegeforyourUserType.
•IfintendingtouseElectronicSignatures,performthefollowing:
oEnabletheSignOffResults1foryourUserType.
oChecktheResultSignOfftabinSystemPoliciesforValidSignOff1Reasons.
◎DetermineifDefaultStringsforResultSignoffiMeaningsandResultSignoff2Meaningscanbecreated.Create、'Pass〃and''Fail"defaultstringsifpossible.
IntheQualificationOverviewdocument,ensurethattheseformsarecompleted:
•QualificationApproval
•IdentificationofPerformersandReviewers
WClt©rS715G05185,RevisionA
THESCIE^NC€OF'Empower,Millennium,NuGenesis,''TheScienceofWhat's.Possible",andWatersareregisteredtrademarks,
andApexTrack,LAC/E,andSystemsQTaretrademarksofWatersCorporation.
CitrixisaregisteredtrademarkofCitrixSystems,Inc.AHothertrademarksarethesolepropertyoftheirrespectiveowners.
Copyright®2016.WatersCorporationMarch2016
Overview
TheEmpowerSystemsQTforSoftwareisspecifictotheEmpower3FR1andabovereleases.TheEmpowerSystemsQTusesawizardtorunthesoftwareIQandOQ.Thereportscanbesignedoffelectronicallyorprinted.Reportsthatdisplaythemethodparametersusedmaycontainblankfieldsbecausetheparametersmaynotbeenabledorpopulatedinthemethod.
ThedatasetusedforIQisablankinjectionandisusedtocreatetheIQreportandallowsforelectronicsignature.TheIQdatasetwascollectedforEmpower3FR3.
ThedatasetusedforinternalstandardcalculationsisidenticaltothatusedinEmpower2154,Empower1154,orMillennium32®v3.2,v3.05.01,orv3.05.
ThedatasetusedforexternalstandardcalculationsisidenticaltothatusedinEmpower2154,Empower1154,orMillennium32v4.0orv3.2.
ThedatasetusedforthemethodvalidationmanagerisidenticaltothatusedinEmpower2154FR3.
YouneednotenableApexTrack™integrationifyourorganizationusestraditionalintegration.
Installationqualification(IQ)
TheIQrepresentstheinstallationqualificationprocessforaWatersEmpower3Personal,Workgroup,Enterprise,orLAC/E32™modulesoftwaresystemconsistingofsoftwareandassociatedhardwarecomponents.
ThepurposeoftheIQportionofthequalificationistoconfirmtheseconditions:
•Personal,Workgroup,Enterprise,and/orLAC/E32modulesoftwarecomponentsareproperlyinstalled.
•Empower3softwareisproperlyinstalled.
•Empower3filesyouinstalledonthesystemarenotcorruptedandremainidenticaltothefliesshippedfromWaters.
•AnyEmpower3softwareoptionsareproperlyinstalled.
•Thenameoftheoperatingsystem,buildnumber,andallservicepacksapply.
•ThetotalnumberofEmpower3nameduserlicensesandsystemlicensesforWorkgroupandEnterprise.
•AnyEmpower3servicepacksareproperlyinstalledandverified.
Softwarefileverification
DuringinstallationoftheEmpower3software,thesoftwareautomaticallyrunsafileverificationutility,whichverifiesthatthediskfilesshippedfromWaterswerenotcorruptedduringInstallation.Thefileusedforthecomparisonisin\Empower\SCRIPT\DIR.CKS.
Thefileverificationfocusesonthesefileattributes:
•CyclicRedundancyChecksum(CRC)
•Filesize
•Filedateandtimestamp
Ifthefileverificationutilitydetectsachangeinanyfile,theinstallationisaborted.Youcanreruntheutilityanytime,torequaiifytheinstallation.
Rule:
ThesoftwaredoesnotoverwritetheoriginalCHECKSUM.TXTfileeachtimeyouruntheVerifyFilesutility.Instead,eachsubsequentCHECKSUM.TXTfilenameisannotatedwiththedateandtime:
forexample,\Empower\SCRIPT\Checksum_il.01.2010_12.23.41.txt.
Operationalqualification(OQ)forEmpowerSystemsQTforSoftwareonly
EvaluateanddetermineiftraditionalintegrationorApexTrackintegrationwillbeusedwhenexecutingtheOQ.
Restoretheappropriateprojectsbasedupontheintegrationchosen:
•TraditionalIntegration一RestoretheValid_OQlproject
•ApexTrackIntegration-RestoretheValid_OQlandValid_OQApexprojects
Ensureallappropriateprojectsarerestored.Ifalloftheprojects(Valid_OQl,Valid_OQApex,andValid_OQMVM)arenotrestoredthefollowingmessagewillappearwhenmakingrequestsfromtheSQTwizard:
Itisnotrequiredtorestorealltheprojects,onlythoseappropriate.Iftheappropriateprojectsarerestored,click、'No〃andcontinue.
TheprojectsprovidedbyWatersarelimitedtoverifyinganddocumentingtheabilityofEmpower3softwaretoperformthesetasks:
•Restoreprojects
•Processstandards
•Processunknowns
•Performpeakintegration
•Performquantification
•Performcalibration
•Generateaprintedreportorsavearesulttothedatabase
Notes:
•WhentheApexTrackIntegrationoptionisenabledandboththeVaiid_OQlandValid—OQApexprojectsarerestored,theresultsetsfortheInternalStdSampleSetandExternalStdSampleSetwillbeavailableinbothprojectswhenanOQrequestisinitiated.
•Thereportscontainan''IntegrationAlgorithm"fieldthatindicateswhethertraditionalorApexTrackintegrationwasused.
OperationalqualificationforEmpowerSystemsQTforSoftwarewithMethodValidationManager
IfyouactivatedtheEmpowerSystemsQTforSoftwareMVMqualification,theOQusestheValid_OQMVMproject.
TheValid_OQMVMprojectisprovidedbyWatersandlimitedtoverifyinganddocumentingtheabilityoftheEmpower3MethodValidationManagertoperformthesetasks:
•Restoringavalidationworkingtypeproject.
•Generatingstatisticalvalidationresultsforallvalidationtests.
•Ensuringthecorrectvalueisgeneratedduringvalidationprocessing.
•EnsureyourestoretheappropriateprojectfoldersforEmpower3FeatureRelease3.
Thereportincludesmethodvalidationresultsandprotocolforthesemethodvalidationtests:
•Linearity
•Linearitycomparison
•LDL/LQL
•Specificity
•Accuracy
•Repeatability
•Reproducibility
•Intermediateprecision
•IntermediateprecisionDOE
•Robustness
•Stability
•Filtervalidation
•Systemprecision
NodeProperties
TheSQTlicenseenablesadditionaltabsinthenodeproperties:
IQInfoandIQ/OQ.
1.InConfigurationManager,selectNodesandthenselectanodetoupdateitsproperties.
2.Right-clickproperties.
3.SelecttheIQInfotab.
•IdentifythecomputercomponentsassociatedwiththissoftwareIQinthespacesprovided.
•WhenyoucompletetheComputerComponentsform,comparetheinformationenteredonitwiththepurchaseorderfortheEmpower3softwaresystem.
•Whenyouinstallsoftwareaspartofareloadingoperationorsoftwaresupportplanupgrade,thepurchaseorderissometimesunavailable.Insuchacase,type''RELOAD"or''UPGRADE"onthePurchaseOrderNumberlineoftheComputerComponentforthatclient.
4.Identifythedocumentationinformationrequiredforqualification.WhenyoucompletethedocumentationInformation,identifyeachdocumentasfollows:
•Ifthedocumentwasreceived,selectYes.
•Ifthedocumentwasnotreceived,selectNo.
•Ifthedocumenthasarevision,entertherevision.
•Ifthedocumentismissingornotapplicable,enterthatinformationinthecomments.
5.IdentifythecomponentsandperipheralsoftheEmpower3systemassociatedwiththissoftwareIQ.
•WhenyoucompletetheConfiguringtheComputerandPeripheralssection,selecteither''Installed"or、'N/A"onthelinecorrespondingtoeachdeviceyouinstall.
•Ifanycommentsapplytotheinstallation,entertheminthecommentssection.
Note:
IftheEmpower3systemwaspurchasedfromWaters,youneednotverifytheconfiguration.Instead,intheconfiguringcomponentsandperipheralssection,certifythatthecomputerwasconfiguredatthefactorybyselectingYes.
6.ClickOK.
RunningtheEmpowerSystemsQTforSoftware
ToruntheEmpowerSystemsQTforSoftware,performthesetasks:
1.LogintoEmpower,usingtheProinterface,asadesignateduserwithafullname.Donotloginasoneofthedefaultusers.
2.Beforethequalificationbegins,ensuretheseconditionsaremet:
a.Theowner'smanagementreviewedtheQualificationOverview,thisprotocol,andanyapplicablereleasenotes.
b.TheQualificationProtocolApprovalForm1-1andtheIdentifyingPerformersandReviewersForm1-2(bothavailablemtheQualificationOverviewdocument)arecompletedandsigned.
3.FromtheEmpowerProwindow,clickConfigureSystem,andthenselectProjects.