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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IssueNo.:02PublicationRef.:VG/11/07

DateofPublication:January2007

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