液相计算机系统验证报告.docx

液相计算机系统验证报告.docx

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液相计算机系统验证报告

D-2000EliteHPLCSystemManager

QualificationReport

ValidationNO：

QC-VAL-151-01

SuzhouHomesunWanqingPharmaceuticalCo.,Ltd

Oct,2010

ReportConfirmation

Responsibility

Department

Name

Signature

Date

Writtenby

QC

李智达

Reviewedby

QC

朱旭平

Auditedby

QC

王瑾

QA

王刚武

Approvedby

QA

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,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

1

890-5705

HitachiModelD-2000EliteHSMinstallationCD

2

1

890-5186

SoftwareValidationcertificate

3

1

890-9605

D-2000EliteHSMInstallationManual

4

1

890-9611

InstructionManual（ForAdministrator,ElectronicVersion）

5

1

890-9631

InstructionManual（ForUser,ElectronicVersion）

6

1

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

CompatiblewithWindowsXP

conforms

Checker/Date:

_____________________Reviewer/Date:

__________________________

6.3Verificationofsensors

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

Installation

Verification（Yes/No）

AIDwasinstalledontotheautosamplercorrectly

Yes

IFBwasinstalledontothepumpcorrectly

Yes

PCwasconnectedwithIFBcorrectly

Yes

AIDwasconnectedwithdetectorcorrectly

Yes

e-lineconnectorwasconnectedwithIFBandAIDcorrectly

Yes

Pumpandautosamplerwereconnectedcorrectly

Yes

Checker/Date:

_____________________Reviewer/Date:

__________________________

6.4Verificationofinstruments

MakesureHPLChasbeenperformedwithIQ,OQ,PQ.Qualificationmeetstheacceptancecriteria,allinstrumentsbeingusedwithintheexpirydates.

InstrumentNO

QualificationDocumentNO

Meetacceptancecriteria（Yes/No）

ExpiryDate

S-08-H-11171

QC-VAL-105-01

Yes

2011.03.25

Checker/Date:

_____________________Reviewer/Date:

__________________________

6.5Verificationofsoftwareversion

Item

D-2000EliteRequirement

Verification

OperatingSystem

MicrosoftWindowsXPProfessional

MicrosoftWindowsXPProfessional

StandardFileSystem

NTFS

NTFS

NTFS:

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

Checker/Date:

_____________________Reviewer/Date:

__________________________

6.6Verificationofsoftwareinstallationprocedure

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

Step

Description

Verification

1

InstallationofD-2000EliteHSMintheWindowsXP

Yes

2

MountingofIFBontheHPLCmoduleunit

Yes

3

InstallationofIFBdriverinthewindowsXP

Yes

Checker/Date:

_____________________Reviewer/Date:

__________________________

6.7Recordingthesoftwareconfiguration

SoftwareConfiguration

1

Setanalysismethodparameter

2

Dataacquisition

3

Chromatographydataprocess

4

Initializeanalysisreport

5

Documentationmanagement

6

Moduleoperation

Checker/Date:

_____________________Reviewer/Date:

__________________________

6.8Verifytheconfigurationofbackupsystems

Backupsystems

Description

USB

TheremustbeaprocedureavailabledescribingUSBshouldbeformattedbeforebackuptoavoidviruscontaminationanddamagetooperationsystemandoriginaldata.

Checker/Date:

_____________________Reviewer/Date:

__________________________

6.9IQshouldbecompletedandapprovedforsystemspriortocommencingtheOQ.Anydeviationshouldberecorded.ASummaryTableiscreatedconfirmingthattheIQwasperformedaccordingtoplanand/orexplaininganydeviationsobserveandtheirresolutionorfollow-upactions.

IQSummaryTable

IQitems

verification

deviation

1

Inventoryofsupplierdocumentation

Yes

None

2

Verificationofhardwareconfiguration

Yes

None

3

Verificationofsensors

Yes

None

4

Verificationofinstruments

Yes

None

5

Verificationofsoftwareversion

Yes

None

6

Verificationofsoftwareinstallationprocedure

Yes

None

7

Recordingthesoftwareconfiguration

Yes

None

8

Verifytheconfigurationofbackupsystems

Yes

None

Deviationdescription:

None

Deviationresolutionorfollow-upaction:

None

IQConclusion:

IQiscompletedpriortoOQ,nodeviationisobserved.IQtesthasbeenpassedandapproved.

Checker/Date:

_____________________Reviewer/Date:

_______________________

7OperationQualific