mind your own businessSERIALIZATIONGET ON THERIGHT TRACK2013
Getontherighttrack2preparefor combatIn an effort to combat counterfeiting, regulatorybodies all over the world are introducing newrequirements for enabling tracking and authenti-cation of pharma and biotech products. Primarilyaimed at codification, serialization (internal andexternal tracking) and e-Pedigree (external track-ing), the new requirements will have major impli-cations for manufacturers, distributors and retail-ers alike.In many countries, such legislation has alreadybeen put into effect and by the end of 2013, theEuropean Medicine Agency (EMA) will introduceserialization legislation, to which all life sciencebusinesses must comply by 2017.Get on the right track – and start preparing forcombat today.A Blessing in disguiseFew will question that serialization requirements serve a greater good: Combatting coun-terfeit is in every pharmaceutical company’s interest - for ethical and economic reasons.However, the imposement of yet another set of mandatory rules - and a short deadline forachieving compliance - is also costly and resource demanding and makes pharmaceuticalmanufacturing even more complex. Even though compliance is of course a goal in itself, it’smoney and efforts well spent to implement serialization – and it is for a number of otherreasons:Combat counterfeitThe chief advantage of applying serializationmeasures is also the fundamental driver behindthe legislation: It combats counterfeit.According to the World Health Organization(WHO), counterfeit drugs account for 7-15 per-cent of all the medicines circulating in developedcountries – and up to 25 percent in developingcountries. It threatens the health and safety ofthe consumers, weakens national economies,emboldens criminal organizations and erode therespect for intellectual proporty rights.When genuine products become more identifi-able, so do the fake ones. Counterfeit drugs areeasily stopped at the point of sale, and whenthere are no money to be earned, the counter-feit business will become less and less attractive.The results are undeniable: Billions of lives aresaved and companies avoid counterfeit-relatedeconomic losses.Optimization of supply chainApplying serialization technology and proce-dures will bring major business benefits, basedon providing more accurate and timely track andtrace information across the entire supply chain,including:• Improved demand, production and distribu-tion planning based on better understand-ing of supply chain dynamics across distribu-tion channels and markets• Improved inventory control across internaland external warehouses• Improved shell life management, reducingscrap• Improved and more cost effective recallmanagement across the entire supply chainProtection of brand valueand integrityIf your product is subject to counterfeit, yourcompany’s image may be compromised.Anti-counterfeiting becomes an ethical dif-ferentiator, as consumers expect companies totake responsibility for combatting fake drugs.Protection of your commercial product by meansof anti-counterfeit thus also protects your brandvalue.Improvement of sales planningand forecastAn effective serialization system can improveyour ability to predict sales developments andmake more precise sales forecasts. The serializa-tion system, in parallel to it’s prime purpose, canalso work as a “early warning system” that canhelp you optimize e.g. sales campaigns.Getontherighttrack3an End-to-EndSerialization solutionNNE Pharmaplan and NNIT have joined forces tooffer consulting and engineering services cover-ing all aspects of serialization, from packaging tothe point of dispense.Together we will take turnkey responsibility foryour serialization project, and we will stay atyour packaging site until the serialization solutionworks perfectly and you have reached your OEEtarget.Both NNIT and NNE Pharmaplan have an insid-ers’ understanding of pharma and biotech pro-duction and are highly experienced in workingwith large complex systems such as SAP objectevent repository (OER) as well as other SAPmodules supporting the supply chain. We canrun projects from consulting through implemen-tation to on-going support, leveraging provenmethodologies and adhering to superior qualitystandards.We work based on a proven model whichprovides an effective method for structuring aserialization project with minimal business riskfor the customer.
Emerging legislationEstablished legislationGetontherighttrack4 Getontherighttrack5serializationlandscapeThe concept of serialization is the same globally, but the scopeand status of requirements differ from region to region.south koreaBackground: Ministry of Health and Welfarenotification 2011 – 58.Timeline: January 2013Timeline aggregation: January 2015Technology: GS1 standard. Data matrix and linearcode GS1-128Based on: Unit level: KD codeSales level: KD code, Exp and LotShipping level: AggregationData scope: KD code (sGTIN), expiry date, lot num-ber, S/N and SSCC codes are mentionedChinaBackground: SFDA, April 9, 2008. Mandatory for275 EDL (Essential Drug List) therapeuticclasses.Timeline: December 2012EDL expanded with +800 classes by2015Letter from the SFDA Department ofDrug Safety Supervision will be issuedwith a two week response period and sixmonths implementation period.Technology: Special 128c codeBased on: Chinese developed authentication code.PIATS (Product Identification,Authentication and Tracking SystemSales level: YesShipping level: Yes, aggregation neededData scope: CNMC (China National Medical Code),S/N and encryption codemiscellanousAlgeria: No regulations, no drafts but authorities are very positive about the EU modelBelgium: Sequential stickersUS: DOD (Dept. of Defense) RFID, Track Trace, inventory management in focusFrance: Vignette stickers and CIP13Egypt: No regulations, no drafts but authorities are very positive about the EU modelGreece: EOF (National Organization for Medicines authenti-cation stickersGermany: Pilot in Q1 2013, national lawItaly: Bollini authentication stickers. Drift towards replace-ment with 2D.Spain: 2006, Article 87 exist but the Royal Decreeis still in draft. Code PDF 417. RFID consideredJapan: Special rules for special drugs regarding staticand dynamic data in code format. No S/N however.Serbia: Stickers solution has been postponedRussia: No regulations, no drafts but authorities are verypositive about the EU modeleuBackground: July 1, 2011 of the EU FalsifiedMedicines Directive (FMD) implementedthroughout 2014 – 2017.Each member state to plan minimumrequirements. Each member state canact earlier when readiness has beenestablished.Each member state can addrequirements (blue box principle)Technology: GS1 data matrix / EAN-13Based on: GS1 standardsItem level: GTIN (minimum)Sales level: GTIN (minimum)Data scope: GTIN-14, lot number, expiry date andS/N was part of prior version of tenderdemands but has been taken out“technical guidance regarding Identifica-tion key, May 17, 2011, version 2IndiaBackground: Directorate General of Foreign TradeDGFT PUBLIC NOTICE No.21/(RE2010)/2009-14, October 1, 2011.Export pharmaceuticals only.Likely to be expanded to import alsobut no deadline. Delays and lawsuitsare rumbling.Will hit low cost generics manufacturedin India hard.Technology: GS1 2D data matrix or GS1-128 1DlinearBased on:Unit level: GTIN, Lot, Exp and S/N, January 2013Sales level: GTIN, Lot, Exp and S/N, January 2013Shipping level: GTIN, Lot, Exp and S/N, July 2012Data scope: GTIN, Lot, Exp and S/N on all levelsTrack Trace mandatoryturkeyBackground: Phase 1, 2009: Mass serialization Phase 2, 2011: Full aggregation Original purpose to stopreimbursement fraud and taxationavoidanceTechnology: GS1 data matrix or GS1-128 linearBased on:Unit level: NoSales level: GTIN, Exp, Lot and S/NShipping level: Yes. Aggregation neededData scope: GTIN, Exp, Lot, S/N and SSCC Database owned by Turkish healthauthorities.AfricaBackground: Counterfeit products on the Africancontinent.Tender and purchasing requirementsstated trough relief organizations andagenesis (WHO, MSF, Red Cross/Crescent and similar). Used since 2005/07with very positive result.Expanded use to be anticipated.Technology: Simple numerical SMS code Can be supplemented by AIDC’s(Automatic identification and datacapture)Hidden (tamper proofed) by means ofMultilayer or “Scratch Lottery Ticket”Based on: Unique numbers Readable for humansData scope: A serial number for verification by SMSbrazilBackground: ANVISA, Brazil law N° 11.903Timeline: January 2012Since “Special Security” label havebeen abandoned, there has been a drifttowards the Turkish model.Technology: GS1 data matrix. Tamper evident(label / hot melt)Based on: Unit level: NoSales level: GS1 data matrixShipping level: Tracking likely to be implementedaccording to Turkish modelData scope: GTIN, IUM (Unique Identifier for Medi-cines), drug registration number, productlot number, expiration dateargentinaBackground: ANMAT Official Bulletin #32.160,regulation 3683/2011. Resolution435/2011Timeline: June 15, 2011 – June 15, 2012 forspecific APIsTechnology: GS1 data matrix / GS1-128 linear / RFID.Tamper evident labeling and visual codeson labels.Based on: Item level: NoSales level: GS1 data matrix with GTIN and S/NShipping level: RFID on shipper boxes and palletsare preferred.Data matrix not banned.Data scope: GTIN (Global Trade Item Number),GLN (Global Trade Location Number)optional but recommended, S/N(Serial Number)Batch number and expiry date areoptional but there must be a linkbetween S/N and Lot/Exp.californiaBackground: California Business and ProfessionCode section 4034 – 4169 Pedigree requirements goes all the wayback to 1987 and is mandatory in manystates. However it’s only in a paperbased hard copy version and fromwhen shipments enter the USTimeline: January 1, 2015 – July 1, 2017Technology: Not definedBased on: Not definedData scope: Full Pedigree in an electronic format(ePedigree) from the original manufac-turing site/lineSource name, registration number(NDC), address, drug name, quantity,dosage form and strength, date of trans-action, sales imvoice number, containersize, number of containers, expiry date,lot number, unique identification num-ber. business name, registration number,addresses and certifying person’sname and address. Certification thatinformation is true and accurate.US OverallBackground: PREDICT database run by DIOP(Division of Import Operations Policy) SNI guideline March 2010 OSD guideline GDP guideline Rx Tec delegated act Tracking guideline (upcoming) FDA will adapt the same angle as EUTechnology: UPC-A or EAN-13Based on: Unit level: NDC codeSales level: NDC codeShipping level: NDC codeData scope: National Drug Code (Static ID code of drug similar to GTIN)denmarkBackground: AMGROS (Danish purchasingassociation for hospitals and clinics).“Demands on barcodes for tendering2013 and expected demands for2014 and 2015”, May 8, 2012.Minimum tender and purchasingdemands 2014-2015 are subjectto changes.Technology: GS1 data matrix / EAN-13Based on: GS1 standardsItem level: GTIN (minimum)Sales level: GTIN (minimum)Data scope: GTIN-14, lot number, expiry date andS/N was part of prior version of tenderdemands but has been taken out“technical guidance regarding Identifica-tion key, May 17, 2011, version 2”canadaBackground: Canadian pharmaceuticalbar coding project.Joint technical statement v002.February 24, 2012Timeline: Phase 1: January 2008, Phase 2: April,2009, Phase 3: 2010, Phase 4: December2012 – December 2017Technology: GS1 data matrix / GS1 Linear / RFID(as supplement)Based on: GS1 standardsItem level: GTIN (minimum)Sales level: GTIN (minimum)Shipping level: GTIN, lot number, expiry date (minimum)Pallet level: GTIN (minimum)Data scope: GTIN, lot number, expiry date, no S/N butcan appear .If end user (hospitals and clinics) wishes.The same goes for RFID. Stated trough purchasing tender require-ments (similar to AMGROS)5
the supply chainlandscapeA Manufacturer1. Production of medicine2. Application of UMI to second-ary packaging3. Case packing4. Pallet packing5. Decommissioning UMIs6. Shipping UMIsi authorities custom officers1. UMIs verification by inspectorsor customs2. Batch recall reportmedicines verification repositoryauthenticate numberupload numberh patients1. Verifying UMIsby mobile phone2. Verifying UMIsthrough a callcenter3. Verifying UMIson the internet4. Verifying UMIs ina retail pharmacyB distribution hub1. Verifying UMIs at goods receipt2. Shipping UMIsC wholesaler1. Decomissioning UMIs2. Re-packagingD re-packagers1. Decomissioning UMIs2. Re-packagingE internetpharmacies1. Verifying UMIsof goods receipt2. Dispensing UMIs3. Decomissioning UMIsf hospitalpharmacies1. Dispensing UMIsof goods receipt2. Decomissioning UMIsg retailpharmacies1. Verifying UMIsat goods receipt2. Dispensing UMIs3. Decomissioning UMIsA 360º approachto serializationj ManUfacturers packaging line1. Serialization and tamper evident packagingof sales units2. Sales unit3. Bundle4. Shipper box5. PalletGetontherighttrack7Getontherighttrack6Serialization affects all steps on your product’s way from the manufacturingline to the patient. Hence, you need to take a 360 look at your production,packaging and distribution when developing and implementing your chosenserialisation technology.NNE Pharmaplan offers full circle support and we have the skills and resourc-es needed to guide you smoothly and effectively through the multi-facetedserialization challenges that arise in early planning and throughout the imple-mentation project.We can help you improve your business case by priori-tizing and coordinatinglocal and functional inputs, e.g. by balancing regulatory requirements withtechnological wishes and possibilities and market requirements.We are familiar with the critical interfaces between the various scientific andfunctional aspects and know how to balance them to reach the most opti-mum solution, which accommodates relevant regulatory requirements andmarket and technology demands. Ultimately, this means increased control-lability and efficiency and minimized risk for you.Organisationalchange managementEnsuring cross-organisational awareness,understanding, capabilities and commitment• Project kick-off and milestone reassessment• Project communication• Design effective organizational setupand procedures• Design and implement tools• Build new competences andunderstanding - trainingABC de fgijhUMI: Unique Medicine Identifierbenefit realizationAligning serialization effort with strategicintend and other business initiativesBuild and manage business case andbenefit realization plan• Identify and prioritize business driversand requirements• OEE baseline and improvement plan• Prioritize and coordinate activities,resources and deliverables acrossprojects, sites and functions• Programme managementFacility designSpecifying, selecting, implementingpackaging lines• Conceptual design• Equipment specification• Vendor management andcommunication• Design for OEEsupply chainmanagementAnalysing, designing and implementinglogistics• Product supply chain analysis• Contract manufacturing assessmentand management• Cold chain, logistics and warehousingautomation itIdentifying, developing, validatingand implementing robust it automation systems• Manufacturing information systems• PLS/SCADA• System interfaces• Serialization software configuration• Vendor managementand communication• Project managementGxP complianceEnsuring right level of GxP compliance,balancing risk, flexibility and efficiency• Risk assessment• Test plans• Validation documentation• SOPscost elementsSCADA / PCS / PLCintegrationOrganisationalchange managementProgram projectmanagementBusiness case developmentcommunicationVendor managementOEE/optimizationperformanceWarehouse solutionMaster data managementTrainingSystems integrationCMO implementationOtherERP implementation Systems InterfaceimplementationVerification validationSerialization SystemimplementationPackaging line equipmentmodificationSOP developmentImproveSolution Price range per line EURFully integratedwith ERP500.000 – 1.500.000Serialization+ Aggregation200.000 – 700.000Serialization 50.000 – 300.00040%40%20%Typical cost distributionCorp Site LineSerialization software• Configuration• Communication with vendor• Interfaces• Systech expertise
8 9Understand• Regulatory status (serialization, GDP, pedigree, codification, etc.)• Best practise in pharma industry• Communication• Stakeholder management (corporate, sites,CMO, partners, suppliers, customers)first deployment• Pilot production• Live test of roll out approachRoll out• Local interpretation of global implementation script• Installation• SAT/IQ/OQ• PQ• OEE optimization• Training• Securing harvest of benefits• Setup of regulatory maintenanceAssess• Checklist-based assessment• Regulatory requirements• Product and market overview• Analysis of requirements vs. capability of processes• Supply chain overview• IT automation strategy• Alignment with other intitiaves (corporate/sites/ partnerships)• Stakeholder engagementPlan• Roll-out master plan (including change management approach)• Business case including benefits,risks and budget estimation (+/-20%)• Recommendations (technology, project organization,vendors, compliance, turnkey vs. individual siteimplementation, etc.)Scope• Execution model• Time schedule• Team set-up• Pre-budget (+/-30%)• Opportunities for business benefits• Business case (key figures from industry)• Risk (prioritized)• Alignment with other initiativesFrom corporate levelwho does whatto site level to Packaging line / Ware houseGetontherighttrackGetontherighttrackInitiate – 1 monthWhat is the scope and consequences of the new regulations,and how do they correlate to other changes and develop-ments in production, planning, supply chain management,it, sales and marketing, etc., which take place concurrently?How can I take advantage of the demanded changes toimplement other changes?A demand for changes can often be exploited to make other, op-tional changes, which can potentially bring huge business benefits.Such changes could entail late stage customization, oursourcingto contract manufacturers, exchange or upgrade of technology orprocesses and streamlining of production flow related to change-overs, release, sampling, etc.What is the business case, and what are the risks?Typically, there is a lot of insecurity in relation to the financial im-plications and risks associated with new requirements. What is theinvesment level?, how does it influence operational results?, andwhat are the risk factors involved in making the necessary changes?All those questions are essential in building a solid business case.Analyse – 1-3 monthsIs it necessary to re-assess the product portfolio in light ofthe added costs and new opportunities/requirements forchanges in package format and design?You may encounter challenges in terms of product profitability one.g. small product series for small markets. You need to make anassessment of whether that should lead to changes in your productportfolio.What are the specific implications for the product flow fromAPI production through packaging lines and supply chain toend-distributor on the different markets?You have to identify which packaging lines, etc. are to supply whichmarkets at which volumes – and thereby determine the requiredtechnology level for each line.What is the level of technology readiness of my packainglines and IT systems (ERP and MES) and in my supply chain?Does anything require change/upgrade/replacement/development?You need a clear assessment of the scope of changes that need tobe developed and implemented in order to proceed.Execute - 6-8 monthsHow do I implement changes and improvements to mypackaging lines, in my supply chain and at my CMOs and stillkeep my obligations to deliver? And how do I make sure Itake full advantage of planned shutdowns and maintanceperiods?How do I ensure that authority approvals are in sync withthe changes in production and package design, so thatthe number of variants and the capital tied up in stock areminimized?If you’re dealing with different approval levels in different markets,the number of new products variants can grow quickly, creating aneed for larger safety stock. This concern must be addressed.How do I ensure effective implementation of new proce-dures, processes and technology on the factory floor withminimal reduction of OEE?The required changes may have significant concequences for workflow and work procedures, which all factory staff, QC and QApeople, etc. have to understand and comply with.Design• Global implementation script (templates, policies, change,checklist)• Detailed design• FAT• Training setup (global, local)• Shipment• GMP• Global ERP/MES• Risk approach• Pre-installation• Regulatory (registration)all foroneTo successfully implement a serialization concept – mitigating risks andleveraging possibilities – it requires careful investigation into a number ofexternal and internal issues. From early planning and throughout the en-tire implementation process, there are important aspects which requirescrutinizing, and this requires involvement from practically all divisions ofyour organization.In this section, we highlight the key questions that companies need toask themselves when converting their processes and business to newrequirements. Our approach to executing serialization projects are basedon a model containing three phases, and we have identified the mostcritical questions in each of the phases.For every project phase, we make available expert resources that willensure successful completion. Hence, we can jump in whenever andwherever you need assistance. We can put together the ideal projectteam, whether we supply resources for the entire team or supplementyour own resources.ManufacturerTaskNNEPharmaplan nnitEquipment vendorSystem vendorReadinessassessmentX(X)ProjectmanagementXXAutomationsolutionX(X)Commissioningand go-live(X)XURSXLineintegrationXXQualificationX(X)XOrg. imple-mentationXSolution design(CD,BD,DD)XXX
10ReferencesA package solutionFIRST IN LINEEstablishing a serialization pilot line to pioneerfor global applicationOur customer offers a wide range of healthcareproducts within pharmaceuticals, vaccines and diag-nostics, generics and consumer health to patients allover the world.With patient safety at top of mind, the customer isputting much effort and many resources into apply-ing anti-counterfeit and product authenticationmeasurements into their production machinery.In October 2012, the company reached a major mile-stone, when they completed the upgrade of thefirst packaging line to comply with the US ePedigreeFactboxAutomation/IT services:• Defining interface between serializationsystem and existing automation and IT systems• Writing conceptual design for local siteserialization solutions• Writing URS/blue print for corporate and localsite serialization system to be implemented• Rollout planning• Creation of local and central staffing plansfor analyze and execute phases• Calculation of serialization solution price• Screening and selection of serializationsolution vendors• Implementation and validation of warehousesolution• Assistance to corporate serialization teamin local site implementation at packaging line• Detailed implementation planning includingcritical shutdown period• Implementation of tamper evidence onsecondary packaging material in parallelwith serialization implementationProcurement services• Procurement management of serializationequipment to local manufacturing sites• Procurement management of corporateserialization solution• Negotiation of price and contract with vendorsValidation services:• Preparation of validation master plan• Validation planning• Control corporate and local CR cases• Writing of overall solution URSrequirements for serialization and aggregation. Theupgraded packaging line – which is placed in thecustomer’s key pharmaceutical plant – is to work asa pilot line for testing the new serialization concept.Over the next four years, the concept will be rolledout to all packaging lines at sites across the world.The upgrade of the pilot line entailed a changeoverfrom manual end packaging to an automized solu-tion. This presented a challenge in terms of fittinga large robot into the limited space of an existingproduction hall. Also, scanners and label printershad to be installed for each aggregation stage tofacilitate the necessary data collection.BETWEEN THE LINESUnique barcodes to prevent counterfeitA vast number of people were involved in the projectwhich entailed work ranging from building a newIT-infrastructure and adapting the logistics chain andproduction processes through procurement of newequipment and change of packaging materials torelease of new standard operating procedures.NNE Pharmaplan provided support for factory andsite acceptance tests (FAT/SAT) and was responsiblefor ensuring compliance with GMP requirements.Moreover, we were in charge of coordinatingand supervising commissioning and for completequalification in all phases in connection with theimplementation of the serialization system and pal-letizing robot.NNE Pharmaplan’s pool of resources counts 350 highlyskilled consultants and project managers withinAutomation IT and packaging lines as well as 30consultants focusing exclusively on serialization.All have hands-on experience from the pharma andbiotech industries.NNE Pharmaplan has provided consulting services inthe serialization field to numerous customers, andimplemented and validated more than 60 packaginglines worldwide to incorporate serialization technology.Below we have highlighted three of our most recentprojects.Our customer has initiated a Global Serializa-tion Programme (GSP) to implement the equip-ment and systems required to comply withglobal codification and serialization require-ments.The program sets out to define a common standardfor serialization processes across the entire supplychain from production to warehouses includingequipment, automation and IT solutions. Each stepin the supply chain checks and reports which serialnumbers have been received and shipped (from/to whom) in order to constantly track the individualproduct.So far, major implications have included the replace-ment of packaging lines, changes in warehouseprocesses and implementation of new IT solutions.All solutions are designed with high flexibility in mindin order to accommodate a diverse and continuouslychanging landscape of requirements.NNE Pharmaplan is assisting in all aspects of the pro-gramme realization effort and is providing resourceswithin the fields of automation and IT, procurementand validation.Even though our customer is not one of thecompanies to be most affected by counterfeit,the company has taken important steps to pre-vent counterfeit issues going forward.In close collaboration with NNE Pharmaplan andNNIT, they are currently introducing a unique 2Dbarcoding system into their worldwide productionplants. The barcode is printed on the packaging andcontains information on where the product origi-nated as well as a unique identification number.From the drawing board to productionThe company initiated their serialization efforts in2009, when they asked NNE Pharmaplan and NNITto assist them in making the right choice of technol-ogy and subsequently to develop a solution whichwould be eligible for global rollout throughout theorganization.The collaboration continued through the implemen-tation phases, where NNE Pharmaplan and NNITperformed impact assessments of all global sites toidentify the amount of work to be done to introducethe 2D barcoding system to each site.The effort requires the production machinery and ITsystems to be converted in order to accommodatethe 2D barcode system.Getontherighttrack11Getontherighttrack10
Project referencesBaselClarens-Sur-MontreuxSan FranciscoIrvineMoscowTianjinTEDAKuala Lumpur(Selangor)BangaloreNoidaNew DelhiMumbaiFrankfurt(Bad Homburg)StockholmUppsalaLundShanghaiLyonCopenhagenKalundborgHillerødHjørringGuangzhouBoston(Cambridge)Research Triangle Park(Morrisville)Philadelphia(Berwyn)Cork(Kinsale)ChartresMarburgSkt. PetersborgOfﬁcesCuritibaBrusselsTangerangJakartaSão Paulotrack record– local projects for a global issueNNE Pharmaplan is the world’s leading engineering and consulting company in the complex fieldof pharma and biotech. We cover all segments from biopharmaceuticals and vaccines to medicaldevices and help our customers develop, establish and improve their product manufacturing.NNE Pharmaplan employs 1,700 people at more than 30 locations around the world.Engineering for a healthier world – our role in an industry that improves people’s lives worldwide.To learn more about our company, please visit our website.NORDICLars OlsenSubject Matter Expert+45 3075 email@example.comThomas BillSerialization Business Consultant+45 3079 firstname.lastname@example.orgNNITTorben VogtSubject Matter Expert+45 3075 email@example.comUSAGilad LangerSubject Matter Expert+1 firstname.lastname@example.orgScan to visitnnepharmaplan.comGlobal Danishmanufacturer of insulinProject:Global solution -serialization + aggregationChinese solution -serialization + aggregationGlobal Swiss pharma-ceutical manufacturerProject:End of line serialization+ aggregation solutionGlobal american pharma-ceutical manufacturerProject:Serialization requirementand product analysisProduct tracking strategyGlobal manufacturerof skin treatmentsProject:Serialization requirementand product analysisProduct tracking strategyGlobal Danishmanufacturer of anti-infection treatmentsProject:Serialization requirement andproduct analysisProduct tracking strategyScoping and planning of globalserialization solutionVersion2-April2013