EmpowerEnterprise验证方案Word格式.docx

资源描述

EmpowerEnterprise验证方案Word格式.docx

《EmpowerEnterprise验证方案Word格式.docx》由会员分享，可在线阅读，更多相关《EmpowerEnterprise验证方案Word格式.docx（18页珍藏版）》请在冰豆网上搜索。

EmpowerEnterprise验证方案Word格式.docx

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.

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.

Requirements:

•Torunthequalification,youmustactivatetheEmpow

展开阅读全文