液相计算机系统验证报告Word格式.docx
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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
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