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.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
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
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