液相计算机系统验证报告Word格式.docx

液相计算机系统验证报告Word格式.docx

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王瑾

QA

王刚武

Approvedby

彭志霞

TABLEOFCONTENTS

1.STATEMENT1

2.SCOPE1

3.REFREENCEDOCUMENTS1

4.GLOSSARY1

5.RESPONSIBILITIES2

6.INSTALLATIONQUALIFICATION（IQ）3

7.OPERATIONQUALIFICATION（OQ）7

8.PERFORMANCEQUALIFICATION（PQ）19

9.ATTACHMENT29

1.Statement

TheobjectiveofthisprotocolistodefinethemainrequirementsandprocessesforqualificationofD-2000EliteHPLCSystemManagerusedinthelaboratoryanalysis.D-2000EliteHPLCSystemManagerisachromatographydatasystemsupportedbyHitachiusedtocontroltheTechcompLC2000HPLCinstrumentwhichalsosupportedfromHitachi,thesoftwarecanexecuteanalyzer’sinputautomaticallyincludingestablishinganalyticalmethod,executingmethodprogram,collectingsampleresponse,acquiringdata,reprocessingdataandinitiatingelectronicrecords.TechcompLC2000HPLClocatedinlaboratories（includingQClaboratoryandin-processcontrollaboratory）,havebeencompletedIQ,OQ,PQtestandapprovedforuse.InordertoprovethatD-2000EliteHPLCSystemManagerisappropriateforGMPrequirementsonlaboratorycomputerizedsystem,QCdepartmentwillexecutethequalification.

2.Scope

ThisprotocolappliestoD-2000EliteHPLCSystemManagerusedtocontrolTechcompLC2000HPLC.

ThisprotocoldoesnotapplytoLC2000HPLCQualification,itonlycontainsapplicablesoftware（ChromatographyDataSystem-PartNumber890-8305）qualification.TheinstrumentqualificationsareperformedaccordingtoQC-VAL-105-01.

ChromatographyDataSystemQualificationandHPLCQualificationconstitutegoodoperationandmaintenanceinHPLCapplication.

3.ReferenceDocuments

3.1GAMPGoodPracticeGuide:

ValidationofLaboratoryComputerizedSystems,2005.

3.2PDAtechnicalreport31,‘ValidationandQualificationofComputerizedLaboratoryDataAcquisitionSystems’,June1999.

3.3GMPRegulations（e.g.–21CFR211.194,91/356/EECCh6,andICHQ7A6.6）

3.4ICHQ7A–GoodManufacturingPracticesforActivePharmaceuticalIngredients,Chapter5.4ComputerizedSystems

4Glossary

4.1ComputerizedSystem:

Computersystem（hardwareandsoftware,includinginfrastructure）withassociatedfunctionsandcontrolledprocess（equipment,users,procedures）,initsoperatingenvironment

4.2Databackup:

Copyofthedataonadifferentmedium（forexamplefloppydisk,cartridge,CD-Rom）toallowdataretrievalincaseofafailureofthemainstoragemedium.

4.3Dataarchival:

Removalofsomesystemdataontomoredurableandhighcapacitystoragemedia（tapes,opticaldigitaldisks）,necessarywhenthedataisnolongerrequiredforroutineworkanddatavolumesaretoogreatforthemainstoragemedium.

4.4Audittrail:

Anaudit-trailisacomputer-generatedrecordingofchangestoGMPrecordsindicatingwhocreatedorchangedthedata,when,andifneeded,why.

4.5ElectronicRecord（orElectronicData）:

CombinationofinformationindigitalformthatismaintainedbyacomputerizedsystemandusedforaGMPregulatedactivity.

4.6Applicableprogram:

AdocumentfolderregisteredinD-2000EliteHSMusedtoestablishandstorageanalyticalmethod,sampletable,dataandreport.Forexample,createanapplicableprogram<

SampleA>

thenauthorizedanalystcouldestablishanalyticalmethod,sampletableinthisprogram,Moreovertheanalystcouldusethemethodandsampletabletoinitialorigindataandreport,

5Responsibilities

5.1SystemAdministrator:

Toinstallthesoftwarepertheuserrequirements,draftthevalidationprotocolandimplementthevalidation,maintainthesystemtocorrecterrors.Completetheprotocolandgenerateapaperreportforreviewandapproval.

5.2QCmanagement（QCsupervisorormanager）:

Toensurethatthesystemisincompliancewithregulatoryrequirementsandthatthevalidationprocessiskeptconsistentwiththeprotocol.

5.3QAmanagement（QAsupervisorormanager:

Toensurethatdocumentation（includingprotocolandreport）areconsistentwithapplicableGMPregulationsandtoverifythattheprocesscomplywithregulatoryrequirement.

6InstallationQualification（IQ）

InstallationQualification（IQ）mustbeperformedtoassurethatthehardwareandsoftwarecomponentsofthesystemareinstalledproperly,andthattherequireddocumentationisavailable.

6.1Inventoryofsupplierdocumentation

Item

Pieces

PartNo

PartName（Description）

1

890-5705

HitachiModelD-2000EliteHSMinstallationCD

2

890-5186

SoftwareValidationcertificate

3

890-9605

D-2000EliteHSMInstallationManual

4

890-9611

InstructionManual（ForAdministrator,ElectronicVersion）

5

890-9631

InstructionManual（ForUser,ElectronicVersion）

6

890-9646

BeforeusingD-2000EliteHSMversion2.0

Remark:

AlldocumentationwillbearchivedinQCdocumentroomandanyelectronicversionwillbebackedupondifferentmedium.

Checker/Date:

_____________________Reviewer/Date:

__________________________

6.2Verificationofhardwareconfiguration

Hardware

LowestConfiguration

Verification

CPU

Pentium4microprocessor,2GHz

Celeron（R）,1.8GHz

Memory

512MB

1G

DisplayMonitor

1024×

768pixels

1280×

960pixels

Harddisk

2GB

250G

CD-ROMdrive

AtleastoneCD-ROMdrive

oneCD-ROMdrive

USBport

AtleastoneUSBport

fiveUSBports

RS-232Cport

AtleastoneRS-232Cport

oneRS-232Cport

Mouse

CompatiblewithWindowsXP

conforms

Printer

Checker/Date:

6.3Verificationofsensors

ForcontrollingtheHPLCinstrumentfromthePC,itisrequiredtoprovidetheUSBinterfaceboard（IFB）andinstalltheIFBdriversoftware.InstalltheAnalogInputDevice（AID）andconnectitwithPCandHPLCperthefollowingfigure:

Installation

Verification（Yes/No）

AIDwasinstalledontotheautosamplercorrectly

Yes

IFBwasinstalledontothepumpcorrectly

PCwasconnectedwithIFBcorrectly

AIDwasconnectedwithdetectorcorrectly

e-lineconnectorwasconnectedwithIFBandAIDcorrectly

Pumpandautosamplerwereconnectedcorrectly

6.4Verificationofinstruments

MakesureHPLChasbeenperformedwithIQ,OQ,PQ.Qualificationmeetstheacceptancecriteria,allinstrumentsbeingusedwithintheexpirydates.

InstrumentNO

QualificationDocumentNO

Meetacceptancecriteria（Yes/No）

ExpiryDate

S-08-H-11171

QC-VAL-105-01

2011.03.25

6.5Verificationofsoftwareversion

D-2000EliteRequirement

OperatingSystem

MicrosoftWindowsXPProfessional

StandardFileSystem

NTFS

NTFS:

Aseniorfilesystemthatprovidesperformance,safety,reliabilityandadvancedcharacteristics.Itkeepstheconsistencyoftherollbystandardaffairslogfunctionanditsrecoverytechnology.InWindows2000andWindowsXP,NTFScanalsoofferadvancedfeaturessuchasdocumentsandfolderspermissions,encryption,diskquotaandcompression.

6.6Verificationofsoftwareinstallationprocedure

ExecuteD-2000EliteHSM（HPLCSystemManager）installationaccordingtoD-2000EliteHSMInstallationManual,recordthewholeprocesstoassuremainsequenceanddetailedoperationofinstallationmaintainingconsistencywithvendorrequirement.

Step

Description

InstallationofD-2000EliteHSMintheWindowsXP

MountingofIFBontheHPLCmoduleunit

InstallationofIFBdriverinthewindowsXP

6.7Recordingthesoftwareconfiguration

SoftwareConfiguration

Setanalysismethodparameter

Dataacquisition

Chromatographydataprocess

Initializeanalysisreport

Documentationmanagement

Moduleoperation

6.8Verifytheconfigurationofbackupsystems

Backupsystems

USB

TheremustbeaprocedureavailabledescribingUSBshouldbeformattedbeforebackuptoavoidviruscontaminationanddamagetooperationsystemandoriginaldata.

6.9IQshouldbecompletedandapprovedforsystemspriortocommencingtheOQ.Anydeviationshouldberecorded.ASummaryTableiscreatedconfirmingthattheIQwasperformedaccordingtoplanand/orexplaininganydeviationsobserveandtheirresolutionorfollow-upactions.

IQSummaryTable

IQitems

verification

deviation

Inventoryofsupplierdocumentation

None

Verificationofhardwareconfiguration

Verificationofsensors

Verificationofinstruments

Verificationofsoftwareversion

Verificationofsoftwareinstallationprocedure

7

Recordingthesoftwareconfiguration

8

Verifytheconfigurationofbackupsystems

Deviationdescription:

Deviationresolutionorfollow-upaction:

IQConclusion:

IQiscompletedpriortoOQ,nodeviationisobserved.IQtesthasbeenpassedandapproved.

_______________________

7OperationQualific