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As a core resource for compliance-based validation in regulated companies, ValGenesis is in the forefront of innovative softwareplatforms with far-reaching results that provide end-to-end validation automation. Seeing that ValGenesis expeditesthe validation process and removes the inefficiencies that plague paper-based processes, implementing ValGenesis, is awise business choice. In that it allows companies to save up to 30-40% in time and money, ValGenesis not only removes thephysical secured document storage space requirement, but it also eliminates the time requirement for tracking the validationstatus. In brief, ValGenesis reduces the audit duration from a few days to just a few hours, improves the efficiency of theentire validation process, enhances quality and consistency, provides a line of defense against internal or FDA audits andreduces the costs of validating entities.
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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:info@valgenesis.com•www.valgenesis.com
IssueNo.:02PublicationRef.:VG/11/07
DateofPublication:January2007
©2004.ValGenesisInc.,Allrightsreserved.MicrosoftWindowsandMicrosoftWindows,NTand2000aretrademarksorregisteredtrademarksoftheMicrosoftCorporationintheUnitedStatesand/orothercountries.OracleisaregisteredtrademarkofTheOracleCorporation
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