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Top Ten Reasons to Implement ValGenesisdocshare01.docshare.tips/files/868/8688068.pdfof the...
Transcript of Top Ten Reasons to Implement ValGenesisdocshare01.docshare.tips/files/868/8688068.pdfof the...
Top Ten Reasons toImplement ValGenesis
Significant Functions and Features of ValGenesis
ValGenesis White Paper January 2007
Table of Contents
Overview ......................................................................................................................................3
Benefit1:TracktheValidationStatusinRealTime......................................................................4
Benefit2:EnforceConsistencyintheValidationProcess.............................................................6
Benefit3:ReducetheValidationCycleTime.................................................................................6
Benefit4:ElectronicExecutionofTestCases...............................................................................7
Benefit5:ManageTestCaseDeviationsthroughControlledWorkflow.......................................8
Benefit6:GreatAuditTrailToolforInternalandFDAAudits.......................................................9
Benefit7:WorkflowDrivenPeriodicReview/RevalidationSchedules.........................................9
Benefit8:AvailabilityofElectronicValidationDataandDocuments..........................................9
Benefit9:StayinCompliance.....................................................................................................10
Benefit10:ReducetheCostofValidationProcess.....................................................................10
Conclusion ................................................................................................................................. 12
Overview
Top Ten Reasons That ValGenesis Ensures Success!Making a Strong Impact on the Corporate Validation Process
Ithasbeensaidthatwithoutchangethereisnoprogressnorarethereincentivesforimprovement.Forthatreason,changeisanecessarycomponentinthebusinessworldasitgenerallyinspiresgreaterefficiencyandmoreadvancedbusinessideas.
ValidationhasbeenanessentialpartofFDA-regulatedindustriesforover20years,yetasthefieldhasevolved,littlehaschangedaboutthebusinessprocessofvalidation.Forthemostpart,validationstillrequiresahighdegreeofmanualeffortfortrackingandreporting,andtheexecutionofmostvalidationprotocolstakesplaceonpaper.Byandlarge,predominantlypaperandmanualbasedvalidationprocessesstifleinnovation,causecomplianceriskandcompromisealifesciencefirm’sabilitytobringproductstothemarketontime.Plus,withtheincreaseduseofcomputersalongwiththeprogressionofevolvingsoftwaretechnology,amoreadvancedvalidationsolutionhasbecomeessentialtothelifesciencesindustry.
Evolving Software Technology from ValGenesis
Inreality,bringingproductstomarketinatimelyfashionusingpaper-basedvalidationisnearlyimpossible.Andsincepaperbasedvalidationprocesshasbecomeoutdated,inefficient,timeconsuming,resourceintensiveandcostlytomanage,Val-Genesisisaninnovationthatreplacesinefficientpaperbaseddocumentationwithamoreadvancedelectronicbasedsystem.Inshort,ValGenesisisafarmoreeffectivesoftwaresolutionthatenhancescorporatevalidationprocessesandassurestheremovalofanydeficienciesinherenttopaperbaseddocuments.
Unique Tool Automates Corporate Validation Process
Asacoreresourceforcompliance-basedvalidationinregulatedcompanies,ValGenesisisintheforefrontofinnovativesoft-wareplatformswithfar-reachingresultsthatprovideend-to-endvalidationautomation.SeeingthatValGenesisexpeditesthe validation process and removes the inefficiencies that plague paper-based processes, implementing ValGenesis, is awisebusinesschoice.Inthatitallowscompaniestosaveupto30-40%intimeandmoney,ValGenesisnotonlyremovesthephysicalsecureddocumentstoragespacerequirement,butitalsoeliminatesthetimerequirementfortrackingthevalidationstatus.Inbrief,ValGenesisreducestheauditdurationfromafewdaystojustafewhours,improvestheefficiencyoftheentirevalidationprocess,enhancesqualityandconsistency,providesalineofdefenseagainst internalorFDAauditsandreducesthecostsofvalidatingentities.
Ensures and Enforces Compliance and Consistency
ValGenesis’suniquetechnologyautomatesthevalidationprocess,dynamicallytrackingvalidationstatusinrealtime,stream-liningtheprocess,improvingcommunicationacrosstheboardbetweenallstakeholders,andensuring/enforcingcomplianceand consistency throughout the entire corporate validation process. Fully modularized with elements for tracking, devel-opment,execution,revalidationschedulesandcontentmanagement,ValGenesiscomplimentsanyexistingframeworkandcloselymatchesthewell-establishedpaperprocess.Inbrief,ValGenesisdoesitall,exceptthatitdoesitelectronicallywithareductioninthevalidationcycletimeframealongwithlesscostforvalidation.
Top Ten Reasons ValGenesis Assures SuccessThebenefitsassociatedwiththeimplementationoftheValGenesissystemaremanyandresultsarequicklyobvious.Todem-onstratetheadvantagesofValGenesis,thefollowingexplainsindetailthetoptenbenefitsassociatedwithValGenesisandexplainshowValGenesismakesastrongimpactonthevalidationprocess.
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Benefit 1: Track the Validation Status in Real Time
Inthecurrentpaper-basedvalidationprocess,trackingvalidationstatusofanysystem,equipmentorinstrumentistimeconsumingandveryoftensubmergedinaseaofpaper.
Overall,validationmanagersandsupervisorsspendaninordinateamountoftimesearchingoutbothvalidationstatusanddocumentsduringtheprocess.ValGenesisisdesignedtoproviderealtime,corporatewidevalidationstatusinjustafewmouseclicks,providingaholisticviewofacompany’svalidationstatusandeasilyidentifyingbottlenecks,whichexpeditethevalidationprocess.Toensureitsefficiency,ValGenesisoffersthreeintuitivewaysoftrackingtherealtimevalida-tionstatusofanyentity(system,instrument,equipmentetc.)corporatewide.
• Tracking the Validation Status with Inventory Report Manager
ValGenesisisdesignedwithadrilldownInventoryReportManagerthatallowsforthetrackingofthevalidationstatusonanyentitythatisregisteredinthesystem.TheInventoryReportManagerstoresentitiesinauser-friendlytreehierarchyforsim-plifiednavigation.Similarentitiescanbegroupedintosubcategories,whilesimilarsubcategoriescanbegroupedunderonecategory.ValGenesisdoesnotrestrictthenumberofcategories,subcategoriesorentities.Below,inFigure1isanexampleoftheInventoryReportManager.
Asdemonstrated,theInventoryReportManagersavesasignificantamountoftimethatwouldotherwisebespenttrackingthevalida-tionstatusofanentity.InValGenesis,anentitycanbelocatedinjustafewmouseclickscompletewithdetailsoutliningthevalidationstatusalongwithUserIDandTimeStampscapturedforeachassociatedactivity,includingdevelopment,executionreview,approvaletc.Figure2,foundbelowisanexampleoftheMetadataassociatedwiththedevelopmentandexecutionofavalidationdocumentthatisgeneratedbyValGenesisandviewedthroughtheInventoryReportManager.
Fig. 1: Inventory Report Manager
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Fig. 2: Validation Document Report
• Tracking Validation Status with Dashboard
ValGenesisalsoprovidesadashboardthatfurnishesinstantaccesstothevalidationstatusofanyvalidationdocumentcurrentlyinthedevelopmentorexecutionphaseofthevalidationlifecycleincludingdocumentsawaitingassignment,underprocess,orpendingapproval.UponloggingintoValGenesis,asshowninFig.3,userswithanappropriaterolecanviewthevalidationdocumentstatusofanyentityregis¬teredinthesysteminrealtime.Thedashboardfeatureisdesignedwithpiechartswitheachpiechartsubdividedintosectionsthatprovideamoregranularlookateitherthedevelopmentorexecutionstages.
Fig. 3: Dash Board
Thedrilldowndashboardprovidesacompleteau-dittrailwitheachactivitycapturedduringreviewandapprovalworkflowscompletewithuserIDandtimestamps.Thisprovidesavaluabledecisionsup-porttoolforallocatinghumanresources,maximiz-ingvalidationteamefforts,andlocatingthecauseofanydelays.
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• Tracking Validation Status with Barcode
AnotherimportanttrackingfeaturebuiltintoValGenesisisthebarcodefeaturethatallowsforthegeneratingofuniquebarcodesforeachentityregisteredinthesystem.Thebarcodefeatureisatremendousaideforanumberofreasons.Asthebarcodesareprintable,theycanbephysicallyattachedtotheentityandusedforidentifyingvalidationdetailsofanentitysimplybyscanning.Whenscanninganentityontheproductionfloor,userscandeterminetherealtimevalidationstatusoftheentityduringanaudit.Thissignificantlyreducesthetimecurrentlyspentonretrievingdocumentsfromadocumentrepositoryandprovidesassurancetowithstandscrutinybyanyinternal,FDAorotherexternalaudits.Inshort,atremendousamountoftimeissavedthroughthebarcodefeatureasitallowsentityspecificvalidationinformationinrealtimeontheproductionfloor.
Benefit 2: Enforce Consistency in the Validation Process
Oneoftheprimarychallengesinthepaperbasedvalidationprocessismaintainingtheconsistencyofthevalidationdocu-ments.Infact,validationconsultantsandengineersmayusedifferenttemplatesforthevalidationdocumentdevelopment,whichmayleadtoinconsistenciesinthevalidationprocess.Buttheenduser—whoisultimatelyresponsibleforthecompli-ance—mightnotwantseveralconsultantsadoptingseveraldifferentvalidationtemplates,eachwithdifferentcoursesofactions,vocabularies,anddocumentstructures.Tothatend,thecorporatevalidationprocedurerequirestheincorporatingofcertainentityrelatedinformationsuchasmodelnumbers,versionnumbers,etc.,inthevalidationdocuments.Oftentheserequirementsareoverlookedandmayleadtonon-compliance.
• Enforce Consistencies through Templates
InValGenesisvalidationconsistencyisenforcedthroughtheuseofvalidationdocumenttemplates.Anynumberofvalida-tiontemplatescanberegisteredinValGenesisandboundtospecificvalidationdocumenttypessuchasDQ,IQ,OQ,PQ,CQetc.OnceatemplateisregisteredinValGenesisandboundwithspecificvalidationdocumenttypes,validationengineersorconsultantsresponsiblefordevelopingthevalidationdocumentsmustusetheconfiguredtemplate.Thisleadstovalidationdocumentconsistencyandenforcescomplianceinthevalidationprocess.Inaddition,whencreatingavalidationdocumenttemplate,headersandfootersareattachedtothetemplatewithtagsforversionnumber,modelnumber,etc.Duringthede-velopmentandexecution,thedocumentwillbepopulatedwithentityrelatedinformationsuchasamodelnumber,versionnumber,etc.,fromthedatabase.Aswiththetemplatecreation,headerandfootertemplatesareconfigurableandeasytocreate.Consistencyinthevalidationprocesscanbeenforcedacrossthesite/companyforusewiththesametemplateforthespecificvalidationtask.ValGenesisuseswordtemplatesandcapturestheMetadataassociatedwiththeentities,whicharepopulatedintheheaderandfooterofthedocuments.
Benefit 3: Reduce the Validation Cycle Time
Duringthemanualvalidationprocess,thereviewandapprovalcyclesaretimeconsuminganduncontrolledbytheinitiator.InValGenesis,thevalidationdocumentdevelopmentworkflowisfullycontrolledbytheapplicationtherebyimprovingthequalityofvalidationdocumentsproduced.Whenadocumentdevelopmenttaskisassigned,thevalidationengineerassignedtothetaskwillbealertedthroughtheTaskAlertFeatureaswellasthroughcorporateemail.Oncethedocumentisdevelopedandsubmitted,reviewersandapproversarenotifiedthroughboththeTaskAlertFeatureandcorporateemailsystem.Essentially,ValGenesisimprovesthecommunicationbetweenassigners,developers,reviewersandapproversresultinginamoreefficientdocumentdevelopmentprocess.
• Time Bound Review Workflow
Thereviewfunctioncreatedfordocumentdevelopmentandexecutionprovidestheuserwiththeabilitytoroutethedocu-mentforreviewafterthedevelopmentandexecutionprocess.Thisfeatureallowsselectedreviewersaccesstothedocumentsimultaneously,permittingcommentsbyallthoseinvolved.Byroutingthedocumentforreviewintandem,thelengthoftimeforreviewisreduceddramatically.Moreover,grantingreviewerstheabilitytoviewallcommentspertainingtothedocumentallowstruecollaborationaswellasincreaseddocumentquality.Oncethereviewperiodhasendedandeachofthereviewers
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hasconfirmedreviewofthedocument,thedeveloperisabletoassessallcomments,makinganyrequiredchangesbeforeroutingthedocumentforapproval.• Approval Workflow with Proxy Approvers
ApprovingvalidationdocumentsinValGenesisisaccomplishedinagenuinelycollaborativemannerwherebyeachapproverintheapprovalworkflowhastheabilitytocommentonthedocumentandrerouteittothedeveloperforrevision.AsValGenesisisequippedwithcontrolledandconfigurableapprovalworkflowscompletewithaproxyapprovaloption,theproxyapprovaloptioneliminatesdelaysassociatedwithpaper-basedapprovalworkflows,whichincludeapproversfailingtocompleteap-provaltasks.Withtheproxyapprovaloption,oncetheallottedtimehaspassedwithoutresponsefromtheprincipalapprover,theapprovaltaskisroutedtotheproxyapproverforapproval.Eachtimeadocumentisroutedbacktotheoriginaldeveloperforrevision,ValGenesisforcesthedevelopertoassignanewversionnumbertothedocument.Oncethechangeshavebeenacceptedand/orrejected,thevalidationdocumentisreroutedthroughtheapprovalworkflow.
TheapprovalworkflowinValGenesisalsoeliminatesdelayscausedbylostormisplacedvalidationdocuments.Sincetheapprovaliscompletedelectronically,thepossibilityoflosingormisplacingadocumentiseliminatedentirely.Eachtimeanapprovaltaskawaitsaresponsefromthedesignatedapprover,amessageissentthroughtheTaskAlertFeatureaswellasthecorporateemailsystemensuringthattheapproverisnotifiedimmediatelyoftheapprovaltask.ElectronicsignaturesavailablewithValGenesiscanbeconfiguredtofollowthecorporatespecificchainofcustodyrequirementsandtoenforcevalidationproceduresandrequirements.
Benefit 4: Electronic Execution of Test Cases
ValGenesisisthefirstproductavailableinthemarketcapableofconductingatestscriptexecutionelectronically,achievinga100%paperlessvalidationprocess.Issuesrelatedtopaper-basedvalidationprocessessuchasphysicallystoringdocuments,manipulatingexecuteddocuments,losingormisplacingexecutedtestscripts,andscanningexecutedvalidationdocumentstoanelectronicformatarecompletelyeliminatedwithelectronicexecution.Executedtestscriptsarestoredelectronicallyinasecuredcentrallocationforeasyretrieval.Inaddition,ValGenesisimprovescommunicationbetweenexecutors,review-ersandapproversofvalidationdocuments,plusspellingmistakesandillegibledataentriesduringtheexecutionaretotallyeliminated.OneofthemostimportantfeaturesofValGenesisandtheexecutingofvalidationdocumentselectronicallyisthefactthatitisfullycompliantwithFDAregulationssincetheUserIDandTimeStampsarecapturedforeachtestcaserow.ValGenesisenforcesaccountabilityduringtheentireexecutionprocessfromtaskassignmenttoapprovals.Duringtheexecution,screenshotsoranysupportingdocumentscanbeattachedashyperlinksatthetestcaserowlevel.Plus,anynumberoffilescanbeattachedwitheachtestcaserow.Theseattachmentsareavailableduringthereviewandapprovalprocessashyperlinks.
Inaddition,duringtheexecution,theWitnessfunctiongivesuserstheabilityto‘witness’duringthevalidationexecutionandcanbeenforcedbasedonqualificationrequirements.BecausethewitnessfunctionalityisbuiltintotheValGenesissystem,itcloselyfollowsapaper-basedprocessandallowsforasecondusertosignoff,verifyingtheexecution.TheabilitytoadaptthewitnessrequirementiscompletelyconfigurablebytheValGenesissystemadministratorattheprotocollevelandcanbeadaptedforspecificGxPentitiesand/orqualifications.
Benefit 5: Manage Test Case Deviations Through Controlled Workflow
Duringtheelectronicexecutionofavalidationdocument,ValGenesistracksalldeviationsthathaveoccurred.Onceadevia-tionisdetectedbythesystem,thedeviationtemplatewillappearwherebytheexecutorwillassessandassignaseverityleveltotheoccurrence.TheInitiatorcanreviewthedeviationsandroutethedeviationsthroughaconfigurableworkflowtoapproverstherebyallowingremedialactiontobetaken.Whenthedeviationisinitiatedandroutedforreviewandapproval,thereviewersandapproversarenotifiedasrequiredthroughtheTaskAlertFeatureandcorporateemailsystem.Essentially,ValGenesisgreatlyimprovescommunicationbetweentheinitiator,reviewersandapproversresultinginamoreefficientex-ecutionprocess.Below,inFigure4istheTestScriptDeviationTemplate.
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Fig. 4: Test Script Deviation Template
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Benefit 6: Great Audit Trail Tool for Internal and FDA Audits
ValGenesishasseveralbuilt infeaturesdesignedtomeetFDAcompliancerequirementsthatwithstandauditinspections.Thesefeaturesincludeaudittrailsfordocuments,administratoraudittrailsforchanges,securitysettingsanduseraccesspermissions,compliantelectronicsignatureswithdateandtimestamps,andasecuredatabasetostoredocumentsandothervalidationrelatedinformation.TheaudittrailsforapprovedandexecuteddocumentsinValGenesisaredesignedtodisplayareportofthevariousstepsduringdocumentcompletionwithassociatedelectronicsignatures,dateandtimestamps.Basedonthecorporatewiderealtimevalidationtracking,ValGenesisreducestheauditdurationfromafewdaystoafewhours.
Benefit 7: Workflow Driven Periodic Review/Revalidation Schedules
Inthecurrentpaperbasedmanualsystem,managinganeffectiverevalidationprogramtoensurethatallcriticalGxPentitiesarerevalidatedontimeiscomplexanddifficulttomaintain.FailingtorevalidatecriticalGxPentitiescouldresultinFDAis-suedwarninglettersandcitations.
WithValGenesis,complexrevalidationschedulesaremanagedbytheapplication.Therevalidationschedulermoduleisde-signedtoalertusergroupsofanyupcomingordelayedrevalidationtasksensuringthatcriticalGxPentitiesarerevalidatedontime.Oncearevalidationschedulehasbeendefinedandapproved,thescheduleisautomaticallywrittentotherevalidationschedulecalendarandusergroupsareautomaticallyalertedofanyupcomingordelayedrevalidationtasksthroughemail
RevalidationschedulerinValGenesisimprovesthelinesofcommunicationbetweenthevariousdepartmentsthroughacon-figurableapprovalworkflowandtherevalidationschedulecalendar.Approvalofrevalidationscheduleswithdifferentgroupshelpstominimizetheimpactoftherevalidationschedulesonotherregularactivitiesincludingproduction.
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Benefit 8: Availability of Electronic Validation Data and Documents
ValGenesis isbuiltonanopenarchitecture toeasily integratewithotherqualitysystems includingchangemanagement,deviation,ERPanddocumentmanagementsystemssoastohaveeffectivebi-directionaldataflow.Inapaper-basedprocess,documentsecurityisoftenchallengedandqualityoftencompromised.Asaresult,developedandexecuteddocumentscanbemisplacedorlostduringthereviewandapprovalprocess.Thenatureofpaperdatatiesittoonephysicallocation,anddistributingcopiesofdatacanbehardtotrackandsecure.
FDAencouragescompaniestomoveintoanelectronicsystemsoastoimprovetheprocessandtoenforcetheconsistencyandquality.BecauseValGenesisprovidesend-to-endvalidationautomation,fromvalidationdocumentnumbergenerationallthewaytoexecutionanddeviationmanagement,itturnsthevalidationprocessintoa100%paperlessandelectronicsystem.ThedevelopedandexecuteddocumentsareavailablewithMetadataappendedinthePDFformatwith128-bitencryption.
TheGoodAutomatedManufacturingPracticeGuide(GAMP),fortestingofGxPsystemsstates,“Computerizedtestmanage-menttoolscansignificantlyreducetheamountofpaperusedduringtestingandcanprovidehelpfultestmanagementsup-port.Thisincludestheabilitytoreportonthestatusoftestactivitiesandfacilitatetestactivitiesbytheuseofwork-flow.Inmostlargetestingprojects,theuseofsuchatoolcanreducetestingtimescales.”ImplementingValGenesisvalidationmanagementsystemofferssignificantvalue,asitiseasytolocate,plusdifferentuserswithdifferentrolesindifferentlocationscanbegivensecureandnon-exclusiveaccesswithcompleteaudittrailandtraceability.
Benefit 9: Stay in Compliance
RecentwarninglettersandcitationsfromtheFDAindicatethatmissingvalidationdocuments,inconsistentdocumentation,disobediencetoValidationProceduresand/orMasterValidationplansetc.,arecontributingfactorsfornon-compliance.Thecostofnon-compliancecanbeexorbitantandincludesarangeofpenaltiesfromtherelativelyminor--suchasadditionalin-spections,lostproductiontime,orun-sellableproducts--tomoreseverecosts--suchasrecalls,plantshutdownsandcompanyfines.Anotherdifficultandsignificantcostcanberelatedtopublicrelations.Themediamaydecidetofeaturenon-complianceissues,withoutregardtohowseriousaproblemmayactuallybetoanorganization.Thefinancialaffectsofnon-complianceonamid-marketbusinesscouldcomeclosetocatastrophic,causingthesmallmanufacturertogooutofbusiness.
ValGenesiscanbeconfiguredtoenforcetheconsistencyinthevalidationdocumentationthroughtemplates.Asengineersandconsultantsarecompelledtousethepreconfiguredtemplateforspecificvalidationdocumenttypes,ValGenesistakescareofpopulatingtheentityinformationincludingmodelnumbers,versionnumbers,etc.,fromthedatabaseasconfigured.DocumentreviewandapprovalworkflowsfollowtheGoodDocumentPractice(GDP).TherevalidationschedulemodulewithrevalidationcalendarandtaskalertfeatureeliminatesthepossibilityofmissingtherevalidationtaskofGxPentity.Duringtheexecution,userIDandtimestampsarecapturedateachrowandscreenshotsonanysupportingdocumentscanbeaddedateachrowtoquantifytheexecution,therebymeetingthestringentcompliancerequirements.SpellingmistakesandtyposarealsocapturedandcanbecorrectedalongwithareasonforthechangewithUserIDandtimestamp.Alldeviationsarehandledthroughcontrolledworkflows.Thedevelopedandexecuteddocumentsareavailableintheelectronicformatwithreadonlyaccessandwithprintcontrols.Inbrief,ValGenesiscanbeconfiguredtoimposecomplianceandconsistencyinthecorporatevalidationprocess.
Benefit 10: Reduce the Time and Cost of Validation Process
Oneofthegreatestchallengesfacingregulatedcompaniesisthehighcostassociatedwiththeinitialvalidation,subsequentchangemanagementandrevalidationtomaintainthevalidationstatusthroughoutthelifeoftheentities.Infact,costsas-sociatedwithtraditionalpaperbasedvalidationcanrepresentapproximatelyone-thirdofthetotalresourcesrequiredforanoverallimplementation.Withtraditionalmanualvalidationprocesses,thehardcostsalsoincludesignificantamountsoftimeforreviewsandapprovalsofdevelopedandexecuteddocuments,aswellastimetomanagetheresultsandtrackthevalida-tionstatusandprotocols.Unfortunately,thesehighcostscanalsodiscouragelifesciencecompaniesfromnewinnovation,andcompromisetheabilitytobringnewproductstomarket.
ValGenesis reduces the validation cycle time and costs by 40-50% by proving the following featuresand functions:
• RealtimeValidationStatus:Eliminatesthetimerequirementtotrackthevalidationstatus anddocuments
• ProxyApprovals:Designatedalternateapproverstoexpeditetheapprovals
• TaskReminder:Emailalertsforthevalidationtasks
• TimeboundReviewandApprovals:Enforcedtimelimitsforthereviewandapprovaltasks.
• WebAccessforValidationTasks:Documentscanbereviewedandapprovedvirtually fromanywhere.
• ElectronicStorage:ElectronicStorageremovesthestoragedocumentspacerequirement.
• Instantreleasetoproduction:Validatedsystemscanbereleasedintoproduction quicklybyaccessingtherealtimevalidationstatus.
• Eliminatestheresourcerequirementsforrevalidationschedulingprocessbyproving revalidationtaskalertsandcollaborativecalendar.
• IntangibleBenefits:IntangiblebenefitsofValGenesisincludeconsistent,compliantand efficientcorporatevalidationprocess.Overall,ValGenesisreducestheriskofwarning lettersandrecallsbyFDA.
Asanout-of-the-boxsolution,ValGenesis requires lessoverall implementationandvalidation time,andallows the infor-mation technology and validation experts within an organization to manage other projects simultaneously. By combiningpre-configuredValGenesisapplicationsoftwarewithuserrequirements,templatesandrapidimplementationmethodology,implementationofValGenesiscanbeachievedinaveryshortperiodoftime.Therapidimplementationmethodologynotonlyprovidesfasterservicebutitalsoaffordsaquickerreturnoninvestment(ROI),lessertotalcostsofownership(TCO)forclientsaswellasgainingacriticalcompetitiveadvantage.
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In Conclusion
Asanintuitive,user-friendlyapplication,ValGenesisismostassuredlyatoolthatcanbeconfiguredtoenforceanyspecificbusinessrulesthatmeetandcomplywiththevalidationprocess.ThoughmanylifescienceorganizationsarecautiousaboutimplementingautomationtechnologiesinFDA-regulatedenvironments,manyothersarediscoveringthatthesetoolsactuallyhelptoreducecomplianceuncer-taintyaswellasdecreasingcostofvalidation.Asvalidationhasbecomeveryimportanttothesuccessandsurvivalofcompanies,automationhasproventogreatlystreamlineoperations.Ineffect,properlydeployedautomationtechnologyactuallylowerscompliancerisk,therebymakingthevalidationpro-cessfarmoreefficient.Onceconfigured,verylittletrainingisrequired,thereforecompaniescanquicklybenefitfromtheadvantagesofferedbyValGenesisandimmediatelybeginrealizingasignificantROI.
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Email:[email protected]•www.valgenesis.com
IssueNo.:02PublicationRef.:VG/11/07
DateofPublication:January2007
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