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TheIDMPChallenge–

PreparingforCompliancewithIDMPRequirements

November,2016

CunesoftGmbH,Luise-Ullrich-Strasse20,80636Munich,GermanyTel:+49-89-23514741

CunesoftInc.,103CarnegieCenter,Suite300,Princeton,NJ08540Tel:+1609-955-3468

Email:[email protected]

CunesoftWhitepaper–TheIDMPChallenge

©CopyrightCunesoftGmbH Page2

Contents1 IDMP:WhatisitandWhy?...................................................................................................3

1 LegislativeStatusofIDMP.....................................................................................................4

2 TheIndustryChallenge–OrganizationalReadinessforIDMP..............................................6

3 BestPracticesforIDMPreadiness........................................................................................9

3.1GeneralProcessSteps–Howtoeatanelephant?...............................................................9

3.2ScopeAnalysis–Analyzingyourdatasources.....................................................................9

3.3Createabusinessplan.........................................................................................................10

3.4UsingIDMP-savvytechnologyversusmanualdataentry..................................................10

3.4.1 MiningyourIDMPdatafromexistingsources.............................................................11

3.4.2 IDMPdatamappingwithcodingsystems....................................................................12

3.4.3 IDMPdatastagingandcurating...................................................................................12

3.4.4 IDMPdatamaintenanceandexpectedlifecycle..........................................................12

4 IDMPsolvedviaRegulatoryMasterDataManagement.....................................................14

4.1SingleSourceofTruth.........................................................................................................14

4.2BenefitsofsolvingIDMPviaaRegulatoryMasterDataManagement.............................14

4.2.1 ReduceIDMPsubmissiontime.....................................................................................14

4.2.2 ReduceIDMPpreparationtimetoaminimum............................................................15

4.2.3 Increaseworkingspeedfromhourstominutes...........................................................15

4.2.4 Reducedatamaintenancecostsby70%......................................................................15

5 SummaryandConclusions..................................................................................................16



1 IDMP:WhatisitandWhy?IDMP stands for the Identification of Medicinal Products and is a general term used whenreferencingthecollectionofISOdatastandards–ISO11615,ISO11616,ISO11238,ISO11239and ISO11240 – that arebeing refined and implementedby regulatory bodies in support ofimprovingpharmacovigilancevia the soon-to-bemandatory submissionof thisdata tohealthauthorities.

IncomparisontoxEVMPD(ExtendedEudraVigilanceMedicinalProductDictionary),thecurrentlegislativeformat,IDMPissubstantiallymoredetailedandcomplex. By standardizing the structure and

terminology used to describe healthcareproductsacrossallmarketsandallmarketingauthorizationholders(MAH),theimpactonhealth care delivery and patient safety hasgreatpotential:

• Improved safety analytics across abroaderspectrumofinformation

• Globally identifiable productinformation

• Complete product compositioninformation

• Enablement of information sharingbetweenstakeholders



2 LegislativeStatusofIDMPInorder tosuccessfully implement thecollectionof IDMP informationviaelectronic submission,astagedoriterativeapproachisbeingutilized.Thismethodcangreatlyimprovethechancesforsuccessforsuchamonumentaleffortandalsoaffordsadaptabilityandflexibilitythroughouttheentireeffort.Thisgraphicdescribesthecurrentgeneraltimelinesanditerations:

Thenextsignificantmilestonesinthisplanarethefollowing:

• PublicationofEUImplementationGuides1Q/2Q2017• StartofimplementationofIteration1forProductsandSubstancesQ1/2Q22018• EnforcementofIteration1forProductsandSubstancesQ3/Q42018

It is expected that Iteration 1 requirementswill include 79 data elements. The finalization of theimplementationguideswilldescribethefinallistofrequireddataelements.Another critical aspect for this implementation is the establishment of the EMA’s master dataroadmapresultinginthedeploymentandavailabilityofasystemofstandardsreferredtoasSPOR–Substance,Product,OrganizationandReferentials.TheEMAdescribesSPORasfollows:• Substancedata,describingtheingredientsofamedicine• Productdata,describingthemarketingandmedicinalinformationrelatingtoaproduct• Organizationdata,providingthecontactdetailsoforganizationsandindividualsresponsiblefor

variousaspectsofamedicine• Referentialdata,providingcontrolledvocabularies(e.g.dosage,pharmaceuticalforms,country

codes,packagecodes,weightcodes)foramedicine,whichareexplicitlydefinedforuseinEuropeEMAwill launchthereferentialsmanagementservice inthethirdquarterof2016,followedbyaninitialreleaseoftheorganizationsmanagementservice.EMAwillcontinuetoexpandthesesservicesincrementallyaftertheirinitiallaunch.



Oncetheseservicesareinplace,stakeholdersshouldstartpreparationstoreplacetheircurrentdatasubmissionformat,theeXtended EudraVigilance ProductReportMessage(XEVPRM)format,withtheHL7SPLformatbasedontheISOIDMPstandards,ISOIDMPtechnicalspecificationsandHL7CommonProduct Model. In parallel, EMA will implement the substance data and product data

management services.Thismasterdatamanagement(MDM)initiativewillprovidefutureservicesaroundmasterdataandenablethebenefitstoberealizedthroughdeliveringvaluetostakeholders.Keygoalsforthisprojectinclude:

• ImplementationofanintegratedMDMsolutionwhichwilldeliverstandardscompliantmasterdataforSubstances,Products,OrganisationsandReferentials(SPOR)

• Collectionofdatathatwillbemanagedandmadeavailabletothenetwork,industryandwiderstakeholder community, in compliance with legislative requirements and the relevantstandardsforprivacy,dataprotectionandsecurity.

• Implementationofanewportfolioofserviceswhichwillbesupportedbystandardiseddatagovernanceandlifecyclemanagement.

• Optimizationofprogrambenefitsrealisedthroughouttheimplementationoftheroadmapbyinvolving and engaging effectively with stakeholders, leading to operating modelsimplificationandefficiencyimprovements.

Theobjectiveofthiswhitepaperistoofferseveralbestpracticesapproachesonhowtoprepareyourorganization for IDMP compliance. Organizations of all shapes and sizes can benefit from theobservationsmadeinthisdocument.



3 TheIndustryChallenge–OrganizationalReadinessforIDMPThe basic fact is simple: IDMP will becomemandatory for everyMarketing Authorization Holder(MAH). It isalso true that IDMPwill require thecuration,managementandsubmissionofamuchwider collection of data when compared to xEVMPD – for example, information such as clinicalparticulars, medicinal products, manufacturers, marketing authorizations, packaged medicinalproductsandpharmaceuticalproducts.Itisalsoverylikelythattherequireddataforthesecategorieswillcomefromseveraldifferentdatasources.Oneprimarysourcewilltypicallybecompanyinternalsystemssuchasspreadsheetscombinedwithdata in internal regulatory informationmanagement(RIM)systemsandotherinternalsourcessuchastheERP(EnterpriseResourcePlanning)system.This internaldatawillneed tobecombined,harmonizedand synchronizedwithdata fromofficialdatabases such as Global Substance Registration System (G-SRS1) previously known as GlobalIngredientArchivalSystem(GinAS)forsubstancerelateddata,theUnifiedCodeforUnitsofMeasure(UCUM)forstrengthdefinitionsandthePharmaceuticaldoseforms,unitsofpresentationandroutesofadministration(EDQM).AtCunesoftwehaveanalyzedofallrequireddatafieldsdefinedwithintheISOguidelinesandofferthefollowingresults:

*EuropeanUnionNetworkDataBoard

1https://tripod.nih.gov/ginas/#/gsrs/

*



Theproposeddataelementsincludethefollowingdataentities:IDMPArea IDMPAttributesMedicinalProduct CombinedPharmaceiticalDoseFormMedicinalProduct AdditionalmonitoringindicatorMedicinalProduct OrphanDesignationStatusMedicinalProduct Name(Med.Product)MedicinalProduct InventedNamePartMedicinalProduct ScientificNamePartMedicinalProduct StrengthNamePartMedicinalProduct PharmaceuticalDoseFormPartMedicinalProduct FormulationPartMedicinalProduct IntendedUsePartMedicinalProduct TargetPopulationPartMedicinalProduct ContainerorPackPartMedicinalProduct DeviceNamePartMedicinalProduct TrademarkorCompanyNamePartMedicinalProduct Time/PeriodPartMedicinalProduct FlavourPartMedicinalProduct ClassificationSystemMedicinalProduct ClassificationSystemValueMarketingAuthorisation MarketingAuthorisationNumberMarketingAuthorisation CountryMarketingAuthorisation AuthorisationStatusMarketingAuthorisation AuthorisationStatusDateMarketingAuthorisation ProcedureIdentifier/NumberMarketingAuthorisation ProcedureType(e.g.MRP/DCP)MarketingAuthorisation Country(nationalauthorisation)MarketingAuthorisation MarketingAuthorizationNumber(nationalauthorisation)Organisation LocationAddressIndication IndicationTextIndication Indicationas"Disease/Symptom/Procedure"Indication Co-MorbidityIndication IntendedEffectPharmaceuticalProducts AdministrableDoseFormPharmaceuticalProducts UnitofPresentationPharmaceuticalProducts RouteofAdministrationIngredient IngredientRoleIngredient SubstanceIngredient StrengthRange(Concentration)Packagedescription PackageDescriptionPackagedescription PackageItem(Container)TypePackagedescription PackageItem(Container)QuantityPackagedescription Material



Thechallengeofcollectingandmanagingthisbroadarrayofdataimpactstheentireorganization–notjustRegulatoryAffairs.RegulatoryAffairsatboththeheadquartersaswellaswithaffiliateswillsharedatamanagementresponsibilities,productregistrationinformation,andultimatelyowntheharmonizationofthis‘masterdata’.

Figure1DepartmentalInvolvementinIDMPfrom2016IRISSForumIndustrySurveyonIDMP2

YourCMCteamswillneedorwantaccesstoasubstancedatabasesuchasG-SRSoraninternalIDMP-compliant system and they will also bear responsibility for collecting data about establishedsubstancesinusewithyourproducts,possiblydefinenewsubstancesnotcurrentlyfoundinG-SRSandinterfacewithCMO’stocollectinformationaboutsubstancesutilizedfromthirdparties.

Medical Affairs will be expected to provide information about clinical particulars – indications,interactions,undesirableeffects–insupportofandencodedwithinyourSmPCs.FamiliaritywithandresponsibilityforcodingterminologysuchasMedDRA,ATCandG-SRSwillalsobeneeded.

Finally,yoursupplychain,qualitycontrolandmanufacturingfunctionswillbeimpacted.Fromtrackinglicensing information for all manufacturers associated with your product to details related topackagingtoawarenessofandadherencetotheregisteredphysicalcharacteristicsofyourproducts.

IDMP readiness and compliancewill beanorganizational responsibility andultimate is astrategicinitiativeinmostcompaniestoday.

Nearlyalloftheleadingmultinationalpharmaceuticalcompanies(i.e.thetop50pharma)wehavespokenwithhavedefinedIDMPasastrategicprojectandhaveallocatedbudgetsrangingbetween5and50millionEurotoaccomplishIDMPcompliance.MostofthemhavealreadycompletedtheirIDMPscopeanalysisandhavestartedimplementingmethodologiestogathertherelevantIDMPdatafromvariousdatasources.

2https://www.iriss-forum.org/news/iriss-publishes-the-results-readiness-surveys-for-idmp



4 BestPracticesforIDMPreadiness

4.1 GeneralProcessSteps–Howtoeatanelephant?With IDMP, there are andwill be significant challenges to face and overcome. Yet, aswith everyjourney,thefirststepsneedtobetaken.Or,inotherwords,answeringthequestion“Howtoeatanelephant?Theanswer?Onebiteatthetime!IDMPreadinesscanandshouldbetreatedasaformalprojectinvolvingprocessstepsthatlogicallybuilduponeachother.TherecommendedbestpracticesprojectstepsforIDMPareoutlinedbelow:

4.2 ScopeAnalysis–AnalyzingyourdatasourcesThechallengeforasuccessfulIDMPimplementationisthefactthatstructureddataoutputisrequired,whilethedatasourcesandexistingdataaretypicallyunstructured.Therefore,akeyelementforasuccessfulIDMPprojectwillbeacomprehensivedatasourceanalysis.Werecommendthefollowingsteps:

1. UnderstandtheISOIDMPscopea. Iteration1b. BeyondIteration1

2. AssessthedifferencesbetweenthedatasubmittedinxEVMPDversusIDMP3. Prioritizedatagaps(mandatory,optional,conditional)4. Analyzedatasources

a. xEVMPDb. Externaldatabases(G-SRS,EDQM,UCUM,MedDRA)c. Externalpartners(CMO,CRO)d. Internal(Medical,Clinical,Legal,PV,Regulatory)e. InternalsystemsRIM,ERP,LIMS,DMS,eCTDf. Legacydata:fileshares,excelg. Documents

i. Electronic



ii. Paper5. Collectsampledatainordertodeterminethelevelofdifficulty(i.e.collectdatafromanERP

systemoranexternalbusinesspartner).Cunesoft offers a structured Excel-based data analysis tool to its clients. The tool contains astructuredlistofallrelevantISOIDMPdatafields,mappedwiththeavailableIDMPimplementationguidelines.In the IRISS Forum’s 2016 Industry Survey on IDMP3, over 80% of the respondents are currentlyconductingagapanalysisoftheirinformationassets.Byconductingthedatasourceanalysis,youwillbeabletounderstandyourinformationlandscapeandtoidentifyyourhighestriskareasforgapsandcomplexities.

4.3 CreateabusinessplanBasedonthedatasourceanalysis,itwillbepossibletodeterminetheeffortsandcostsforcollectingtherelevantdatafromthebestpossibledatasources.Thebusinessplanshouldincludeariskanalysis,i.e.whathappensifIDMPcomplianceisnotachieved.(i.e.calculatethepotential5%penaltyofannualnetsalesrevenueaspotentialriskfactoragainstthecosts).Itisalsoimportanttoincludedatavisibilityandrelatedauditrisksintothecalculation.i.e.abroadsetofdatawillbesubmittedtotheauthority.WhilebecomingcompliantwithIDMPrequirementsimpliescertaincosts, it isequallyimportanttobuildabasecasethatalsoidentifiesthebenefits.GatheringabroadsetofdatasuchastheIDMPdatais a very powerful source for regulatory reporting and improving organizational effectiveness. Forexample,drugefficacycanbeanalyzedonamuchmoregranular(countryorevenpatient)levelandinsightscanbeusedtoincreasetheoveralldrugefficacyandpatientsafety.

4.4 UsingIDMP-savvytechnologyversusmanualdataentryAn importantconsideration for theexecutionof the IDMPprojectwillbewhether toperformtheIDMPdataentrymanually,tooutsourcethecurationtoanoutsidefirm,ortobuild/acquireasoftwaretooltosupporttheIDMPsubmissioncreationprocess.In May 2015, Cunesoft conducted a survey with 75 life sciences companies across Europe. Thisrevealedthatmorethan85%areconsideringtheacquisitionanduseofatacticalsoftwaretoolorastrategicsoftwaresolution.Lessthan5%planmanualdataentry.

3https://www.iriss-forum.org/news/iriss-publishes-the-results-readiness-surveys-for-idmp



TheIRISSForumsurveyalsolookedintotheintendedtechnicalapproachforprovisionofIDMPdataandfoundthat69%ofrespondentsintendtosubmittheinformationviathegateway:

4.4.1 MiningyourIDMPdatafromexistingsourcesThe reality is that IDMP can be collected and enteredmanually. However, the reasons for usingtechnology to gather andmaintain IDMP are driven by initial and ongoing operational costs. Thepotential costs for manual data maintenance of hundreds of data fields per European marketauthorization can be significantly higher when compared to using usable and efficient softwaredesignedspecificallyforIDMPsubmissioncompilationandmaintenance.IntermsoftheinitialcurationofthedataneededforpopulatingIDMPinformation,recenttechnologyinnovationshavemadetheconceptofdocumentdataminingareality.WithasubstantialpercentageoftheIteration1datacurrentlylivingindocumentssuchasanSmPC,anopportunitypresentsitself



toutilizeintelligentdocumentdataminingtechnologiestoautomatetheextractionandencodingofnearlyhalfoftherequireddata.Cunesoft’scune-Distillerisadocumentdataminingsolutionthatisspecificallyconfiguredtoextract,encodeandmergeIDMPdatafromSmPCdocuments,xEVMPDfilesandevenCTDdocumentssuchasthosefoundinthe3.2.Psectionofasubmission.

4.4.2 IDMPdatamappingwithcodingsystemsOne of the new challenges with IDMP are coding requirements and controlled vocabularies. Asdescribed in a previous section, external databaseswill need to be used tomap IDMP datawithmultiplestandardcodingsystems.Lookingatiteration1,forexample,clinicalparticularssuchasindicationshavetobeextractedfromtheSMPCandalsoneedtobereferencedwiththecorrespondingMedDRAcodes,lowleveltermsandSOCclassifications.ActivesubstancesandExcipientsusedinmarketedproductsneedtobemappedwithG-SRScodes.Additionally,otherstandard terminologiessuchasDosageForms,OrganizationsandRoutesofAdministration(tonameafew)willhavetobecodedviayettobereleasedreferentialandorganizationdatabasesbytheEMA.

4.4.3 IDMPdatastagingandcuratingFollowing curation of the initial data, companies looking to utilize a technology solution considermanagementplatformsthatalignwiththeIDMPdatamodelandcanproducecompliantIDMPdatafilesforsubmission.UnstructuredIDMPdata,preparedasdescribedinthesectiondatamininganddatamapping,willberequiredtobematchedandstagedwithotherstructureddata,comingfromRIM,MDM,ERPorothersystems.Cunesoftofferscune-IDMP–amoduleinitsRegulatoryOperationsPlatform–withagrowingnumberofcompaniesacrossEuropeutilizingthesoftwaretogatherandmanagetheirIDMPdata.Innearlyallcases,thesecompanieshaveachievedanROIinlessthan6months.

4.4.4 IDMPdatamaintenanceandexpectedlifecycleTheentireIDMPdatamodelincludes1200datafields.Mostlikely,whenreachingiteration3,500-750datafieldswillneedtobesubmittedandmaintained.Manualmaintenanceofsuchlargeamountsofdatawillnotscale. It isrecommendedthateachIDMPproject includesastrategyforongoingdatamaintenance.WefullyexpectthattheIDMPsubmissionlifecyclemanagementwillfollowthecurrentxEVMPRMlifecyclemanagement,whichincludeelectronicmessagereceiptofauthorityacknowledgments.



WhenusingsoftwaretechnologyforIDMPdatamaintenance,agatewayconnectortofacilitatethedatatransfer(sendandreceipt)toandfromthehealthauthorityshouldbeconsidered.Furthermorethesoftwaretechnologyusedshouldincludebusinessrulestomanagedatachangesasautomatedaspossible. For example, an alert shouldbe sent internally to the IDMP responsibleperson, if IDMPrelevantdataischanginginanyothersystem.Ideallysuchchangeswillautomaticallybeupdatedbyawell-designedIDMPsoftwaresolution.



5 IDMPsolvedviaRegulatoryMasterDataManagement

5.1 SingleSourceofTruthMasterDataManagement(MDM)approachesarebeingusedinmanyorganizationstocreateasinglesourceoftruthforrelateddata.Forexample,themanufacturingdivisionusesanEnterpriseResourceManagement (ERP) system,which contains production-relatedmaster data. Finance typically usesanotherinstanceormoduleoftheERPsystemorhasitsownfinancemasterdatasystem.SalesusesaCustomerRelationshipManagementSystem(CRM),whichconsolidatesallcustomerrelateddatainonesystemforsalesandmarketing.Insomecase,theCRMsystemmaybeconnectedandintegratedintotheERPsystem.Withinlifesciencesorganizations,RegulatoryAffairshassignificantstrategicimportance.However,inmost cases, no regulatory master data management systems are available or implemented.Unfortunately, in many companies, we have observed an Excel sheet-based regulatory datamanagementapproach.RegulatoryInformationManagementSystem(RIMS)havebeenthefirstattempttomanagebroaderregulatorydatawithinasinglesystem.Insomecases,theexistingRIMSenvironmentcanbethebaseformanagingIDMP-relateddata,butwouldneedtobecustomizedsignificantlytoalsobecomethesinglesourceoftruth.Thegraphicbelowdescribesthehighlevelconceptforaregulatorymasterdatamanagement.Why is a single source of truth important? Let’s look at a very simple example and its compleximplications-Ibuprofen5mg:Thesubstanceitselfwouldbedescribedinthesubmissiondossier.TheIDMPrelevantsubstancecodewouldneedtobeextractedviaG-SRSandthestrengthterminologywouldcomefromUCUM.WithinanIDMPsystem,youwillneedtoconsolidatethesedifferentdatasetsandcombinethemtoonecompounddataset,theIDMPdataset.Conductingthisdatacollectionmanuallyjustforasinglemedicinalproductcanbetimeconsuming.Now,let’sexploreaveryrealisticscenarioofadatachangethatishappeninginoneoftheinternalsourcesystems:If,forexample,G-SRSisapplyingachangebutthereisnonotificationinplacethattellsyoutoalsoupdateyourIDMPcompounddatasetintheIDMPsystem,theabilitytokeepeverythingsynchronizedandharmonizedbecomesnearlyimpossible.

5.2 BenefitsofsolvingIDMPviaaRegulatoryMasterDataManagementImplementingaregulatorymasterdatasystemforthepurposeofIDMPwillenableorganizationstogainprocessbenefits,costsavings,increasedproductqualityandultimatelywillsetthefoundationtoincreasetheircompetitivepositioning.Thefollowingbenefitscanbeachieved:

5.2.1 ReduceIDMPsubmissiontimeWith an information management platform specifically designed to meet IDMP data collection,



validation and submission creation requirements, the process of actually producing an IDMPsubmissionisquiterapid.

5.2.2 ReduceIDMPpreparationtimetoaminimumByleveragingaregulatorymasterdatamanagementapproach,there-useofdataandmetadatawillbeenabled.Dataredundanciesareeliminated.Dataaccuracyisguaranteed.Organization-widedatacollaborationisachieved.Externaldataproviders(i.e.manufacturingpartners)canalsobeintegratedinthedatacollectionprocess.

5.2.3 IncreaseworkingspeedfromhourstominutesByprovidinguserswithuniqueprocessoptimizationfeaturessuchasintegratingexternaldatabases(i.e. G-SRS, EDQM, UCUM etc.), the data collection and data management process are reduced.Familiarandusefultaskmanagementallowsuserstodistributeworkitemsandtrackthecompletionofthesetasks.

5.2.4 Reducedatamaintenancecostsby70%AsolutiondesignedwithIDMPneedsinmindcanensureautomaticdataupdatesviadefinedbusinessrulesaswellasautomaticdatacollectionfromanytypeofotherinternalsourcesystem.



6 SummaryandConclusionsSubmissionsofIDMPdataforalreadyapprovedproductswillbecomelegislativelyeffectiveinEuropeinmid-2017.FDAandHealthCanadahavegiventheircommitmenttoISOIDMPandareexpectedtofollow with a legislative deadline shortly thereafter. And once the FDA publishes the legislativetimeline,companieswillhavea24-monthwindowuntiltheFDAlegislationbecomeseffective.PMDAJapanisparticipatingininternationalISOIDMPupdatemeetingsandisexpectedtojoinIDMPaswell.Inotherwords,theconclusioncanbemadethatIDMPwillbecomeaglobalstandard.Cunesoftrecommendsthatallorganizationssee IDMPasa“opportunityforastrategicevolution”.Publiclyavailablestudiesconfirmthatfortoday’spharmacovigilancerelatedpharmaceuticalproductmanagement,upto100minutesperproductperyeararebeingusedtosimplykeepingthedatauptodate.WiththeincreasedcomplexityofIDMP,thisyearlyeffortwillincreasebyafactorof3to5times.AccordingtoarecentstudyconductedbytheUniversityofLeipzig,Germany,it isestimatedthatwithmasterdatamanagement,theyearlymaintenancetimeforcomparabledatarecordssuchaspharmaceuticalproductdata,canbereducedto20minutesperyear.Therefore,whenlookingatthecomplexityofIDMP,thelogicalsolutionistheimplementationofaregulatorymasterdatamanagementsystemthatnotonlyfulfillsIDMPcompliancerequirements,butwill also provide tremendous efficiencies – and savings – for your regulatory informationmanagement.

ContactDetails:CunesoftGmbHLuise-Ullrich-Strasse2080636MünchenGermanyPhone:+49(0)89-23514741

CunesoftInc.103CarnegieCenter,Suite300Princeton,NJ08540USAPhone:+1(609)955-6348

Website:www.cunesoft.com Email:[email protected]

Cunesoftcanprovidehelpwith: IDMPTraining IDMPDataAnalysisToolsandServices BusinessCaseCreationWorkshop RegulatoryMasterDataManagementWorkshop IDMPsoftwarecune-IDMP&cune-Distiller