PARTNERING WITH CUSTOMERS TO MAKE DIGITAL QUALITY A …axendia.com/blog/wp-content/uploads/2019/09/Axendia-Sparta-Conn… · anticipated disruptions to their business. Much of this

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PARTNERINGWITHCUSTOMERSTOMAKEDIGITALQUALITYAREALITYSPARTACONNECTION2019EVENTBRIEFBy:DanielR.Matlis,President

INTRODUCTION

Thethemeatthisyear’sSpartaConnectionwas:“MakingDigitalQualityaReality.”UndertheleadershipofDanaJones,CEOofSpartaSystems,thecompanycontinuestofocusoncustomersuccessbydeliveringoncommitments,ensuringtransparency,andbuildingrelationshipstoearncustomertrust.

“We’re100%committedtoputtingcustomersatthecenterofeverythingwedo,andtopartneringwiththemtoacceleratetheirtransformationtodigitalquality,”saidMs.Jones.“We’realsocommittedtogivingourcustomersmaximumfreedom,flexibilityandchoicebyprovidingarangeofoptionswithourcloud,on-premiseandhybridoptions.”

Tosupportitscommitmenttoprovideflexibility,freedomandchoicetodeliverqualitybasedoncustomerneeds,Spartaisinvestingacross3dimensions:

TrackWise®QMS–SpartaannouncedtheircontinuedcommitmenttotheTrackWiseon-premiseproductforexistingcustomers.Theyalsoannouncedthatthenextversionoftheproduct,TrackWise10,willbecomingoutin2020.TrackWisehybridsolution-TrackWisecustomerscanexpandthefunctionalityoftheirexistingon-premiseinstancesbyseamlesslyaddingTrackWiseDigitalcloud

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SPARTACONNECTION2019EVENTBRIEFmodulestoTrackWise.ThisincludescloudmodulessuchasComplaints,IntakeandSupplierQualityManagement.

TrackWiseDigitalSM–over120customerhaveselectedTrackWiseDigital

USINGAITODRIVEPREDICTIVEQUALITYThecompanyannouncedthelaunchofitsAI-augmenteddecisionmakingcapabilitiestoenableashiftfromreactivetoproactivequalitymanagement.AxendiahasadvisedSpartaontheuseofAI.(Read:AIDrivesShiftfromReactivetoPredictiveQuality)OurresearchshowsthatAIsoftwareisspurringpositivedisruptionandinnovationinQMS.AIissupportingtheshifttoaproactiveandpredictiveapproachtoqualitymanagementsinceitcandetectandaddressqualityproblemswellinadvanceofwhatcanbedonetoday.SpartaisapplyingmachinelearningandnaturallanguageprocessinginTrackWiseDigitaltoauto-categorizeintakeofcomplaintsandqualityevents,drivingimprovedproductivityandintelligentdecisionmakingacrosstheorganization.ThenewAIcapabilitiesenableorganizationstoimproveusers'productivitybyleveraginghistoricalqualitydatafromTrackWiseandTrackWiseDigitaltodeterminethelikelylevelofriskofanewcomplaintorqualityeventsothatthemostimportanteventscanbeidentifiedandresourcesallocatedmoreeffectivelyandefficiently."We’retremendouslyproudtobethefirstcompanytoembedartificialintelligenceintoQMSforLife-Sciences,”saidVinitDoshi,ChiefOperatingOfficeratSparta.“ThisisthefirststepinourinnovationroadmaptobuilddeepAIcapabilitiesintoourproducttoassisthumandecisionmakingandultimatelyhelpourcustomersrealizethevisionofpredictivequality.”

EXPANDINGSPARTA’SSOLUTIONFOOTPRINTSpartaalsoannouncedtheavailabilityofthenextversionofTrackWiseDigitalDocumentManagement(DMS).TrackWiseDigitalDMShasexpandedcapabilitiestosupportlargeenterpriseimplementations.IntegratingdocumentmanagementwiththeTrackWiseDigitalQMSinstancemakesiteasytoorganizealldocumentsinasingleplace.Built-inworkflowsandaudittrailshelpeliminateredundancyandlowerstheriskofmanufacturingproductswithunapprovedoroutofdateSOPs.ItalsomakesiteasiertooverseesuppliersandContractManufacturingOrganizations(CMOs).

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SPARTACONNECTION2019EVENTBRIEFCONNECTINGQMSANDLMSCAPABILITIESSEAMLESSLYSpartaSystemsandULLLCannouncedapartnershiptobringtogetherSparta'scloud-enabledqualitymanagementsystem(QMS),TrackWiseDigital,andUL'slearningmanagementsystem(LMS),ComplianceWire®.ThispartnershipwillallowcustomerstoconnecttheirQMSandLMScapabilitiesseamlesslyandrealizemorevaluethanwithtwosystemsoperatingindependently.Thetwocompanieshavecommittedtoinnovatetogethertocreatestronglinkagebetweenqualitycontent,learning,humanperformanceandrelatedqualitymanagementprocesses.DELIVERINGJUST-IN-TIMEGUIDEDWORKINSTRUCTIONSTODIGITALFACTORYFLOORANDLABORATORYWORKERSSpartaandProceedixareworkingtogethertodeliverjust-in-timeguidedworkinstructions.Thissolutionprovidesaccesstostep-by-stepworkflowprocedurestosupporta"rightfirsttime"qualitycultureonaninnovativeplatformforexecutinginstructionswithmobileandwearabletechnology.Throughthispartnership,SpartaandProceedixwilldevelopsolutionsthatenabledigitalfactoryfloorandlaboratoryworkerstoaccessimportantdocumentsandjust-in-timecontentatthepointofneed.ThegoalistotransformStandardOperatingProcedures(SOP)andworkinstructionsintojust-in-timeresourcesthatarepresentedwithclearlanguageandvisualsinastep-by-stepformat.WHYAREREGULATORSINCENTIVIZINGTECHNOLOGYMODERNIZATION?

Inmykeynoteaddress,Idiscussedwaysregulatorsareincentivizingtechnologymodernization.Unfortunately,industry’shyper-focusoncomplianceisoftenanobstacletoquality,innovationandmodernization. AxendiaanalysisshowsthatLife-Sciencecompaniesdonotofteninvestinsystemsortechnologybecauseofcostandanticipateddisruptionstotheirbusiness.MuchofthisisduetoalackofclarityontheFDA’sexpectations.Theagencyhasmadeitclearthatitwantstoencouragethepharmaceuticalindustrytoimplementstate-of-the-art,innovativequalitymanagementsystemsforpharmaceuticalmanufacturing(readDoYouWantLessFDAInspections?HereisFDA’sRX).

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SPARTACONNECTION2019EVENTBRIEF AccordingtoDr.ScottGottlieb,23rdCommissionerUSFDA“…attheFDA,we’refocusedonpropellingtheseinnovations,collectivelyreferredtoas‘advancedmanufacturing’.Advancedmanufacturing,whichincludesvarioustechnologies,suchascontinuousmanufacturingand3Dprinting,holdsgreatpromiseforimprovingtheAmericanmarketfordrugsandbiologicals.”Tosupportindustry’smodernizationanddigitaltransformation,theAgencyhasanumberofkeyinitiativesunderwayincluding:

UsingDigitalEvidencetoAccelerateInnovation QualityConsiderationsforContinuousManufacturing FDA’sNewApproachtoCSV

Ialsoshared,indetail,Axendia’sperspectiveontheroleofArtificialIntelligence(AI)playsdrivingtheshiftfromreactivetopredictivequality.Additionally,IdiscussedtheregulatoryconsiderationforAIenabledQMS.Tolearnmore,readourlatesteBookhere:AIDrivesShiftfromReactivetoPredictiveQuality.INBRIEFSpartaismakingsignificantinvestmentstoprovideflexibility,freedomandchoicetodeliverqualitysolutionsbasedoncustomerneedstobemorenimbleandresponsivetochange.Byofferingarangeofcloud,on-premiseandhybridsolutions,thecompanyisprovidingitsconsiderablecustomerbasetheabilitytoundergodigitaltransformationattheirownpace.Atthesametime,Spartahasmadesignificantinroadsontheadoptionofitscloudoffering,TrackWiseDigital.SpartaisinvestingheavilyininnovationwiththerolloutofnewAIfeaturesthatsupportpredictivequalityandarobustroadmaptohelpcustomersachievedigitaltransformation.Spartaisalsoexpandingitsofferingsthroughorganicdevelopmentandpartnerships.WewillcontinuetomonitorandreportonhowSpartaexecutesitsvisiontomakedigitalqualityareality. ThisBriefwaswrittenbyAxendia,Inc.TheopinionsandanalysisexpressedinthisBriefreflectthejudgment of Axendia at the time of publication and are subject to change without notice.Informationcontainedinthisdocumentiscurrentasofpublicationdate. Informationcitedisnotwarranted by Axendia but has been obtained through a valid research methodology. Thisdocumentisnotintendedtoendorseanycompanyorproductandshouldnotbeattributedassuch. AboutAxendia:

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SPARTACONNECTION2019EVENTBRIEFAxendia is a leading analyst and strategic advisory firm that focuses exclusively on the Life-Sciences markets. Since 2005, Industry stakeholders and regulators have relied on Axendia for trusted advice on Business, Regulatory and Technology issues and trends based on trusted sources. Axendia serves the entire Life-Science ecosystem ranging from start-ups to Fortune 100 companies including: Life-Science Organizations, Technology & Service Providers, and Regulatory Agencies. Axendia professionals offer a unique combination of deep hands-on industry experience coupled with forward thinking insights. We contribute to our client’s success by providing long-range visibility and helping them navigate the increasingly complex landscape. Formoreinformation,[email protected]

ReadAxendia’sblog:Life-SciencePanoramaathttp://LSP.axendia.com

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PublishedAugust2019