- Reviewing the challenges associated with implementation and integration of serialization and traceability technology - Best practice strategies for integrating technology with enterprise IT systems to support end-to-end business processes - Ensuring seamless data exchange between packaging infrastructures and your MES, ERP, repository, warehouse management, regulatory and partner IT systems - Common pitfalls and how to avoid them - Could blockchain be the answer?

1. Overcoming TechnicalInteroperability
and Integration Challenges
Planning,Preparationand CommonPitfalls
Standards, technologies, implementation and vendor overview
© Pasi Kemppainen, 2017

2. PleasureMeetingYou!
I’m entrepreneur and executive consultant for pharma digitalization strategic initiatives and advisory both for
biopharma and pharma companies. The customer assignments cover IoT and industrial internet projects, and range
from helping with the digitalization strategies to implementing global regulatory compliances such as
manufacturing IT GMP/GAMP, medicine serialization and traceability. In this capacity, I’m working as a global lead
serializationandtraceability programfor SantenPharmaceutical Co.Ltd.
In addition, I’m Principal Advisor for Epista Life Science, a leader in life science compliance consulting and advisory.
Prior to this, I worked as Senior Consultant and Advisor for NNE, Novo Nordisk engineering and consulting
company.
I served as Chief Executive Officer at Original1 GmbH (a joint venture of SAP, Nokia and Giesecke&Devrient -
leaders in enterprise IT, mobile and security) servicing a cloud and mobile platform for product serialization,
traceability and consumer authentication services in Europe and China. In Europe, Original1 focused in serialization
and traceability services for pharma, consumer products and manufacturing industries. In China, Original1
commercialized the first drug traceability and authentication cloud and mobile service for pharma companies and
consumers utilizing China FDAElectronic DrugMonitoringService.
Before joining Original1 I headed Nokia Authentication Solution business in Nokia China empowering consumers
and businesses to authenticate product originality and counterfeits using their mobile phones. The products
coveredconsumer products, drugs and ID cards and ultimately the solutionwas selected as the best anti-counterfeit
solution inChina by China RFID Journal and China Anti-counterfeit Association. Before heading Nokia Authentication
Solutionbusiness, I led the incubationof new businesses at Nokia Ventures Organization.
I am also working on Ph.D. dissertation on pharmaceutical digitalization technology and business disruption at
Lappeenranta University ofTechnology Faculty ofIndustrial Engineeringand Management.
© Pasi Kemppainen, 2017

3. The Big Picture
© Pasi Kemppainen, 2016

4. Serializationand Traceability Will Impact The
Entire Solutions Architecture and Costs
Source: TraceLink

5. Serializationand Traceability Integrationand
Interoperability– Why so Difficult and Expensive?
• Serialization investments and costs can be roughly divided based on the organizationaland
technology responsibilities
New packaging line equipment
Serialization vendor (line + site + project)
Enterprise IT (ERP, repository, archiving, …)
Regulator, customer and partner connectivity
InternalFTEInternalFTE
ExternalFTEExternalFTE
Packaging
Art work
Validation
Production
Maintenance
PMO
Architecture
Security
Platforms
Validation
Project management
Vendor management
Installation
Validation
Documentation
Training
Project management
Vendor management
Installation
Validation
Documentation
Serialization Aggregation
Warehousing IT
Supply Network IT
Investments CostsCosts
© Pasi Kemppainen, 2015
Enterprise IT
Online Coding Tamper Evidence
Compliance

6. Infrastructure Integration and Interoperability
© Pasi Kemppainen, 2016
In addition, SOP and WI
changes,competence
developmentand
training
© NNE, 2016

7. SerializationImpacts on OEE and Production
Output and Costs
© Novo Nordisk, 2016

8. Infrastructure Integration and Interoperability
© Pasi Kemppainen, 2017
In addition, SOP and WI
changes,competence
developmentand
training A
B
C D
EF G
© NNE, 2016

9. Infrastructure Integration Points
*) Enterprise ApplicationIntegration:http://www.slideshare.net/PeterREgli/enterprise-application-integration-technologies
• Currently,”theintegration” is mostly based on either (closed) proprietary interfacesor
non-interoperable interfaces(no common data vocabulary and process orchestration)
• Futureintegration should be based on the open and standardized interfacesand
platforms already used in the industry for Manufacturingand Enterprise Application
Integration*
© Pasi Kemppainen, 2017

10. MasterData Integrationis Essential in the
IntegrationStrategy
SupplyChain
Network
Integration
Serial Number
Management &
Global
Repository
Packaging Line
Integration
Warehouse & ERP
Integration
Master Data
Integration © Tracelink, 2016
© Pasi Kemppainen, 2016

11. © Teva, 2015
TevaGlobal Serialization and Traceability
Architecture

12. Open Serialization Communication Standard
(Open-SCS)*
• Open-SCS initiativeaddresses the pharma industry’s serializationand traceability
implementation interoperabilityand integration requirements
• The Open SCS Working Group is partnered with OPC Foundation to develop an open
source standard for the use cases, specifications and implementation guidelines
• The work is focused on the standardizing the integration points between enterprise
serialization management functions and packaging lines
• Enterprise and site level interfaces (levels 3-to-4, C integrationpoint))
• Packaging line and site level interfaces (levels 2-to-3, A integration point)
• Specifications based on GS1, OPC Foundation and ISA-95/88standards
© Pasi Kemppainen, 2016
*) https://opcfoundation.org/open-scs-working-group/
https://www.youtube.com/watch?v=-odjnefDHIM

13. Open-SCS Packacing Line System Configurations
© Open-SCS, 2016
Open-SCS
PSS 1.0
(2017)
Open-SCS
PSS 2.0
(2018)

14. Open Serialization Communication Standard
(Open-SCS)
• Open-SCSPackaging Serialization Specification 1.0(PSS 1.0) is now ready with the
supportfor L3-L4integration and interoperability in
• Serial number provisioning
• Serialization report transmission
• Batch & master data repository
• Unused serial number return
• Open-SCSPSS 2.0 (ready in 2018) will cover L2-L3integration and interoperability,
potentially the supportfor*
• Batch data management: Batch master data request and full batch import
• Serial number management: Request, inquiry, reporting and unused serial number return
• Aggregation and reconciliation (?)
*) https://opcfoundation.org/wp-content/uploads/2015/09/Serialization-Standard-Feasibility-Study_Draft_2015-0903.pdf © Pasi Kemppainen, 2017

15. Why Open-SCS is Important for Pharma Industry
“The OPC Foundation strongly supports this important standards
effort launched by leading vendors and pharma companies across
the global pharmaceutical supply chain. The developmentand broad
adoption of practical open standards has been our mission since day
one and this effort will be a key foundation in realizing the benefits
of the Internet of Things (IoT) across the pharmaceutical
serialization ecosystem.”
Tom Burke, President and Executive Director of the OPC Foundation
http://www.logisticsforthelifesciences.com/logistics/regulatory/open-scs-reports-track-and-trace-model-progress

16. Strategizing Infrastructure IntegrationArchitecturesandinterfaces
Processanddatagovernance
SecutiryandAAA*
Platforms,servicesandsolutions
Competencesandqaulifations
Partnersandvendors
Competences
Internal External
*) AAA = Authentication,AuthorizationandAccounting
Programand projectgovernance
Financial management
• Standardizeon interfaces,
platformsand systems
• Select right partners
• Have a competentteam
• Engage the product supply
partnersearly on
• Plan for the long-term
• Engage the decision makers
• Prepare for unexpected costs
and problems
• Have a faith and trust
© Pasi Kemppainen, 2017
Strategic planning

17. Multivendor Integrationand Interoperability
Scenario
Regulator,customerand partner connectivity
0-2
3
4
5
SAP ECC SAP ATTP
Site Server
Systech Optel
Master data
Recipes
Process Order
Batch reporting
Serial numbering
Post-lot operations
Warehouse integration
GS1 EPCIS SAP PML Vendor specific interfaces
MES (Werum)
TraceLinkLife Sciences Cloud
Company data
Master data
Partner data
Master data
Recipes
Process Order
Batch reporting
Master data
Recipes
Batch reporting
Serial numbering
Post-lot operations
Serial numbering
Aggregation
Production
key processes
Serializationand
traceability
key processes
CMO/CPO network management
Serial numbering
Logistics operations
Regulatory reporting
© Pasi Kemppainen, 2016

18. Case:Pfizer and McKessonEPCIS Interoperability
Pilot (2012)
• Pfizer coordinated with McKesson an EPCIS pilot with all participants well-versedin
EPCIS, yet they still ran into interoperability issues becausedifferentcompanieswere
using and interpretingthestandardsin different ways.The learnings fromthe pilot
were
1. All trading partners must adopt the EPCIS guidelines in the same way
2. All trading partners must follow a common interpretation of EPCIS events and
extensions for each use case
3. Watch out for dependencies, repurposed data elements, and precedence relationships
Proposal: If in doubt,checkwith yoursupply chain partnersto confirmyou are both
following and interpretingguidelinesin the same way beforeyou begin exchanging
eventdata.
Source: http://www.healthcarepackaging.com/trends-and-issues/traceability-and-authentication/avoid-these-epcis-interoperability-pitfalls

19. Case:Novartis ”Industrial Internet” Platform
(RUTH)
• Novartis has created a standardized automation infrastructure backbone ‘RUTH’ to reduce
procurement costs as well as both engineering and qualification effort
• CentralizedOSIsoft PI System as the ’IoT platform’connectingwithlevel 2 systems
• Eachlevel 3 application has a standardizedinterfacewith the PI System
• Standardizedequipmentandoperatingproceduresenablethe flexibility withproducttransfers
• As datastructures and transfersare harmonized,thisalso enables faster andcheaper
technologytransfer from R&D to manufacturing
Source: Novartis

20. Will Blockhain be the Answer?
• Blockchain is essentially a highly distributed,secureand trusted ledger (list of records) for
recordingtransactionsbased on cryptography and decentralized architecture
• Blockchain is unparelled in enabling uncompromized consensusand tamper-proof
transactions between the untrustingstakeholders(i.e. recording undeniableand non-
reversibleevents)withoutintermediaries
• Blockhain is the answerwhen
• High level of transaction security is needed
• The transactions need to public and everyone can hold a copy of all transactions
• There’s no trust between the stakeholders
• Centralized system with an intermediary party is not wanted
• Privacy is critical
• Transaction non-reversibility and tamper-proof is required
• Low transaction processing performance (and high cost) is not an issue*
© Pasi Kemppainen, 2017*) There are proprietary high-performance blockchainplatforms

21. Will Blockhain be the Answer?
© NNE
© Pasi Kemppainen, 2017

22. Will Blockhain be the Answer?
• As a very secure, scaleableandinteroperabletechnology,blockchain coudbe a perfect fit for
serializationandtraceability
• Store securily the batch serial numbers and supply network EPCIS events in blockhain
• Provide everyone with the permission to read and hold a copy of the all transactions in the network
• Unlimited network scaling with no transaction interoperability problems
• However, the reality is more complicatedthanthat
• Pharmaceutical regulation requires a legal entity accountable for the blockchain network
• Pharma blockchain can’t be public (like in Bitcoin), so it must be setup and operated as a private blockchain by
the customer and authority audited and approved entity
• Decentralization of transactions is not wanted (everyone having a copy of all supply chain transactions/events)
• There must be a contractual trust between the trading parties – company/facility audits to validateíng the trust
• Privacy is important but the identities must be available between the trading partners
• Transaction performance is critical (i.e. proof-of-work cant’ be used for securing the block)
• Transaction non-reversibility and tamper-proof is required but can be implemented already with the current
solutions – we can’t trust on the current systems and processes data integrity?
• You still need to integrate your serialization system (L3 or L4) with the blockchain network(s)
• For serialization and traceabilityinthe pharmaceutical industry,blockchainissolving the serialization
and supplynetwork integrationproblemsyet anotherway (very novel waythough!)
• Don’t get me wrong – I’m big fan of the blockchain but let’s be realistic with the pharma industry regulatory
requirements and implementation complexities © Pasi Kemppainen, 2017

23. Ironically…
© Pasi Kemppainen, 2017

24. THANK YOU
WISH YOU A FANTASTIC END OF THE YEAR AND MERRY XMAS!© Santa Claus, 2017