JETTBlankURSWord文件下载.docx
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JETTBlankURSWord文件下载.docx
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1stRevisionoftheBlankTemplatebasedoninputfromusersviaJETTmonthlymeetings,email,andtheJETTwebsite.
2
09/15/2003
MRivera
FormatreviewbasedoninputfromusersviaJETTmonthlymeetings.
3
06/30/2004
RevisedtheBlankTemplatebasedoninputfromusersviaJETTmonthlymeetings,email,andtheJETTwebsite.
Therevisionhistorysectionshouldbeutilizedduringdevelopmenttoprovideinformationthatwillallowthereviewer/approvertounderstandwhatpart/partsofthedocumentis/arebeingrevised.Foraninitialrelease,provideanotethatthedocumentisbeingroutedforinitialreview/approval.Thiswillensurereviewers/approversevaluatetheentiredocument.IntherevisionsummaryincludetherevisionnumberoftheBlankTemplateusedtocreateanyequipmentspecifictemplates.
(ReminderofPageIntentionallyLeftBlank)
TableofContents
1.0Introduction(SCope)4
2.0Overview5
3.0OperationalRequirements6
3.1Capacity6
3.2ProcessRequirements6
3.3ProcessControl6
3.4Functions6
3.5DataandSecurity9
3.6Environment11
4.0Constraints13
4.1MilestonesandTimelines13
4.2EquipmentConstraints14
4.3CompatibilityandSupport14
4.4Availability16
4.5ProceduralConstraints16
4.6Maintenance18
5.0Life-Cycle19
5.1Development19
5.2Testing19
5.3Delivery19
5.4Support21
6.0Glossary22
7.0References23
8.0Approval24
9.0Attachments25
ProjectNo.:
InserttheuniqueprojectnumberassociatedwiththisparticularURS.
DocumentNo.:
InserttheDocumentIdentificationNumberandRevision.
DocumentDescription:
Insertdescriptionofdocument,e.g.PURESTEAMGENERATOR,JETTExampleUserRequirementsSpecification.
1.0Introduction(SCope)
Note:
Insertyourowndescriptionandintroduction.Youmaywishtoincludeyourownrequirementsandspecificstoprovidetheinexperiencedreader,contractors,andsuppliersanadequateexplanationtounderstandthescopeoftheequipment.
Describewhoproducedthedocument,underwhatauthority,andforwhatpurpose.
Describethecontractualstatusofthedocument.Includeorreferenceasanattachmentthe“legal”paragraphthatcommunicatespurchasingtermsandconditionsinthissection.
Describetherelationshipofthisdocumenttootherdocuments.ThisisimportantforequipmentthatispartofanintegratedprocessorlineandwillhelptheSuppliertounderstandandaskquestionsthatmayotherwisebeoverlooked.
RefertotheEquipmentValidationPlanthatoutlinestheSupplier’sresponsibilitiesisattached.
Removeanyoptionsthatarenotapplicableforthisproject,ifotheruseswillapplylisteachseparately.
Thisistobeutilizedasaguidefortheusertoanswerthemajorityofquestionsinvolvedinspecifyingthe“what”fortheequipment.Addendumsmaybeusedtoroundouttherequirements.
2.0Overview
Thisdocumentencompassesthenormalrangeofequipmentoperations.Thissectionshouldbeexpandedtoprovideahighleveldescriptionofthesystemexplainingwhyitisrequiredandwhatisrequiredofit.Includethebackground,keyobjectivesandbenefits,mainfunctionsandinterfaces,applicableGxPrequirements,andotherapplicableregulations.Obviously,technologyimprovementsandnewapplicationsmayrequiredeviationfromthistemplate.
TheUsershouldconsiderincludinginformationonthefollowing:
2.1Use:
Describewhatapplicationstheequipment/systemwillbeusedtosupport.Includeabriefexplanationofthegeneralfunctions.
Forexample(foraWideRangeFiller):
2.1.1Thewiderangefillerlineshallprocesspharmaceuticalvialsundersanitaryconditionswiththefollowingfunctions:
vialfilling,putstopperstovials,oxygenreduction,samplecheckweighing,andvialeject.
Forequipmentdealingwithsoliddosagepharmaceuticalproductsdirectly:
2.1.1Theproductsbeingdevelopedonthespecifiedequipmentareof:
2.1.1.1Lowactive(vitamins,supplements)
2.1.1.2Mediumactive(e.g.Aspirin)
2.1.1.3Highlyactive(e.g.Morphine)
2.1.1.4Exclusive(e.g.Penicillin)
2.2Capacity:
Provideabriefdescriptionoftheequipment/systemcapacityrequirements.
2.2.1TheequipmentshallbecapableofproducingXYZproductcontinuously,overan8-hourshift.
3.0OperationalRequirements
ThisSectionshallstatetheoperationalrequirements:
systemfunctions,dataandinterfaces.Itshallalsodefinetheenvironmentinwhichthesystemmustoperate.Criticalrequirementsshallbespecificallyidentifiedassuch.Includeprocessdescriptionsandflowchartsasappropriate.
3.1Capacity
3.1.1Rangeofproducts
3.1.2Commoditiestobeused(i.e.vials,bottles,tablets,etc.)
3.1.3ProcessedMaterialstobeusedorinvolved
3.1.4Productionrates
3.2ProcessRequirements
3.2.1Qualityofproductsandconcentrations
3.2.2Productlimitations(i.e.temperature,humidity,pH,etc.)
3.3ProcessControl
3.3.1MeasurementRange
3.3.2SetpointRange
3.3.3ParameterControlTolerance
Ataminimum,listthecritical,processparameters.Considerdocumentinghoweachoftheparameterrequirementswasdetermined.
3.4Functions
3.4.1Operation
Enteryourspecificoperationalrequirementshere.
3.4.1.1Cyclesexpectedthesystemwilloperateatare…
3.4.1.2Recipesthesystemwillcontainare…
3.4.1.3Operatorinteractionwiththesystemwillinclude…
Thefollowingisanexample:
3.4.1.1Thesystemshalloperatewithaminimumofoperatorinvolvement.Operationshallbesafefromanoperatorandenvironmentalstandpoint.
3.4.1.2Thesystemshallbeoperatedlocallyattheequipmentitself.
Controlsystemrequirements:
3.4.1.4Manualonly
3.4.1.5Manual/automatic
3.4.2Powerfailure/Recovery
3.4.2.1PowerFailure:
Insertyourspecificpowerfailure/recoveryschemehere.
Forexample:
Intheeventofapowerfailure,thesystemshallprotectinthefollowingpriority:
3.4.2.1.1Personnel
3.4.2.1.2Equipment
3.4.2.1.3Product
3.4.2.2RecoveryMethods:
Insertyourspecificrecoveryschemehere.
3.4.2.2.1Manuallyre-startbasedonoperatorinputs(Operatorinitiatespowerrecoverysequence).
3.4.2.2.2Re-startbasedonlaststatebeforelossofpower.(Systemrunsthroughpowerrecoverysequencewhenoperatorstartsignalisgiven)
3.4.2.2.3Ifthereisanautomaticbatchreportingsystem,theinformationshallberetainedintheeventofapowerfailure(AUPSisrequiredforautomaticbatchreportingsystemsfordataretention).
3.4.3“EmergencyStop”
Insertyourspecific“EmergencyStop”(E-Stop)strategyandcommunicationschemehere.
3.4.5.1ThesystemshallhaveanE-Stopmechanismdesignedtostopallphysicalmovementoftheequipmentimmediately.TheE-Stopmechanism(s)shallbelocatedineasilyaccessibleareasaroundtheequipmentasrequiredbynationalandlocalsafetystandards.
3.4.4AlarmsandWarnings
3.4.4.1“Criticalalarms”-Insertyourspecific“CriticalAlarm”actionschemehere.
3.4.4.1.1CriticalAlarmsshalltakeactionviainterlock(s)and/oroperatorproceduralresponsetoshuttheequipmentdownandnotifytheoperatorofthecondition(s).Theoperatorshallberequiredtoacknowledgethealarmbeforethealarmcanberesetandthesystemrestarted.Oncethealarmisreset,theoperatormayrestartthesystem.
3.4.4.2“InformationalMessages”shallnotifytheoperatorandtakenofurtheraction.
Foracustomizedequipmentapplication,includeanalarmtable,liketheexamplethatfollows.
3.4.4.2.1TheEquipmentshallhavethefollowingcriticalalarmsandwarnings:
AlarmorInformationalMessage
CriticalAlarm
StackpoleLightIllumination(color/flashing)
InformationalMessage
Response
Interlock(s)
OperatorProcedural
EmergencyStop
X
ControlPlatformCommunicationWatchdog
ControlPowerFault
MainAirFault
XXXX
YYYY
ZZZZ
MotorFaults
CONTROLPLATFORMBatteryLowWarning
Thelistofcriticalalarmsinthetableisnotintendedtobeacomprehensivelistofallalarmsforthesystem.AcompletealarmlistwillbedevelopedandincludedintheFunctionalSpecificationdocument.
Forastandardequipmenttypeapplication,requestthesuppliertosubmitthecompletealarmlistanddifferentiatebetweencriticalandnon-criticalalarms.
Considerdocumentinghow“criticalandinformationalmessage”criterionsweredetermined.
3.5DataandSecurity
ControlsprovidedwithDataCollectionsystemsintendedforuseinthemanufactureofpharmaceuticalproductsshallberequiredtomeet21CFRPart11compliance.
3.5.1UserInterfaces
Thissectionshouldaddressthefollowingissues:
3.5.1.1Userinterfaceaccesslevels
3.5.1.2Frequencyofdatapointcollection
3.5.1.3Hardcopy/electronicdatacollectionrequirements
3.5.1.4Compliancewith21CFRPart11(forEurope-ERECGuidelines)
3.5.1.5Dataretentiontimeonthesystem
3.5.1.6Datastoragemedia
AccesstoallInput/Outputvaluesandsystemstatusbitsshallbeprovidedthroughadata-communicationlink.Securityfordataandoperatoraccessisprovidedby(UserID/Password,CardReader,Biometric(Fingerprint,eyescan,voicerecognition,etc.).
3.5.2UserInterfacewithSupervisorsandOperators
Insertyourinterfaceschemehere.
3.5.2.1TheCONTROLPLATFORMsystemshallincludeinterfaceswiththeOperatorandSupervisorthatensureseasy,safe,andreliableoperation.
3.5.2.2Anoperator-interfacepanelsh
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