cmo-mah integration challenges & success...

1© 2017 TraceLink Inc. Confidential with No Further Distribution

Stanley Samuel, Group Manager, EMEA (CMO/3PL)

CMO-MAH Integration Challenges & Success Factors


Global Track and Trace Becoming Business as Usual

N. & S. America

Asia

EMEA

Additional Draft Regulations in DevelopmentEgypt, UAE, Mexico, Columbia, Libya, Algeria, South Africa, Albania, Cameroon, Ukraine, and more

Argentina Argentina

US US US US

China China China (new?)

S. Korea S. Korea S. Korea S. KoreaIndia

India India India

Saudi Arabia Saudi Arabia

Brazil

European Union

Turkey

75+% of global medicines covered by barcoding, track and trace regulations in 20192014 2016 2018

2015 2017 2019

France

Belgium

Italy

Nigeria

Kenya

Philippines

Chile

Iran Italy Russia Russia

Jordan

Australia Taiwan?Japan

Pakistan?

Jordan

India (domestic?)

Japan

Argentina

Pakistan


Countries Following or Align with EU FMD

• EU Member States

• European Economic Area countries− Norway− Iceland− Liechtenstein

• Switzerland

• Countries with serialisation/coding schemes in place can get additional 6 year transition time− Belgium (likely to align with 2019)− Greece (likely to align with 2019)− Italy (likely to use extended time)


EU Serialisation, Reporting, Verification ModelHigh Level Data Exchange Structure

EuropeanHub

ParallelImporter/Distributor

Wholesaler Pharmacy Wholesaler Pharmacy

NationalSystem NationalSystem

� Manufacturer packages and serialises drug product, manages serialisation events in internal and 3PL distribution sites� Manufacturer submits Product, Packaging, Status data into European Hub

- Regulation provides for submission directly to a National System� Parallel Importer / Distributors submit Product, Packaging, Status data into European Hub� European Hub pushes information such as pack data to the National Systems� Pharmacies perform verification inquiries against a National System� Wholesalers and Parallel Distributors perform risk-based verification queries against a National System

Packaging Site CMO 3PL

PharmaManufacturer


18 months or more

12-18 months

How far in advance of regulatory deadline should the CMO have ordered upgrades/software to support your organization?


Readiness, Concurrency and Resource Conflicts#

Part

ners

to O

nboa

rd

Resource Capability

Procurement Spike

OnboardingSpike

1. Resource peaks are beyond industry and company capabilities and extend project timelines

2. No company can onboard more than a few partners in parallel

3. There are many opportunities for delay at each phase of the project


The Integration Challenge


Serialization Data Exchange & Provider LandscapeSerialization Framework: ISA-95 Model (OpenSCS)

•Enterprise Software• Inconsistent Regulations•Evolving Interfaces•Frequent Updates (Validation)•High Scalability

•Packaging Equipment• Insulated from Regulations•Fixed Interfaces• Implement and ‘don’t touch it’•Focus on OEE


Integration Requirements & ApproachesInternal system design leads to unique and complex integration

NETWORK TENANT• Single connection to network• 1 * 9-month integration• Integration included

Minimize resources intensive integration and validation requirement

PharmaCompany

CMO Integration

1 Simple

2 Not defined

3 Not defined

4 COMPLEX

5 COMPLEX

6 COMPLEX

… COMPLEX

# Companies Top-40COMPLEX 10

Not defined 11

TraceLink Integration 19

POINT-TO-POINT

• Connection to each customer• N * 9-month integration• $20,000 per integration


We’d like to split and combine messages by content and event type!We’d like to send messages by event type or

chronological sequence!We’d like to add a “last file transmission” marker!We’d like to add a few extra data fields!

EPCIS is Necessary but Not Sufficient

Line Management Systems (L1-2)

Site Server (L3)

Enterprise Repository “EPCIS” (L4)

Proprietary Interface

MaHMaHMAH

We’d like to use a specific file-naming convention that includes custom data parameters!

1. Push2. SOAP Request/Response3. SOAP Request/Async Response4. Full Async

CMO

SN Request/Response

Commission/Aggregation/Ship

Support multiple Data Formats

EPCIS versions


Network (L5)

SN Request/Response

Enterprise Repository “EPCIS” (L4)

CMO providesextra data fields andprocess triggers

StandardEvents

TraceLinkdeveloped/supported

plug-insSanofi Plug-In Teva Plug-In

Commission/Aggregation/ShipCMO

21 of Top 30 Require Custom InterfacesA combination of additional data fields and transaction choreography


The On-boarding Process


Program Resource Management Plan understanding the Constrained Market Resources

Strategy• Internal/External

• LMS/Enterprise

CMO Program Management

TraceLink Network Success

CMO 1 CMO 57In

tern

alIm

plem

enta

tion

Leve

l 4/5

Prof

essi

onal

Se

rvic

es

15© 2017 TraceLink Inc. Confidential with No Further Distribution© 2017 TraceLink Inc. Confidential with No Further Distribution

MAH TraceLink CMO/CPOPrioritize CMO onboarding:

readiness, volume, importance

Manage communication to CMOs including artwork

Communicate requirements to CMO(s)

Attend format testing calls

Work with CMO for data and choreography testing

Provide technical expertise for specs call

Establish integration with CMO

Create relationship and educate CMOs

Assist with format testing

Attend data and choreography testing call to provide technical

assistance

Serialize lines

Work with MAH on artwork changes

Prepare country, data and choreography requirements (IT)

Work with TraceLink to establish integration

Execute testing process

Internal Program Management / External Consulting Organisations Leverage efficienciesInformation collection

Best practices Guidelines Resources

Project coordination


TraceLink IntegrationSpecs Discussion

Serialization Tasks and OwnershipPrerequisites

MA

HC

MO

Trac

eLin

k

CMO & MAH Coordination

Line SerializationData and

Choreography Specs Discussion

Data and Choreography

Specs Overview

Send integration form to CMO

Complete integration form

Add CMO to network and begin

integration

Conduct educational call

Test file format to TraceLink

Test business data and choreography Go-Live

Assist with testing as needed

Note: If completed before, just contact NSM Receive TraceLink

Integration Completion Certificate




MA

HC

MO

Trac

eLin

k Assist with testing as needed





Specs Overview






Trac

eLin

k

Receive form completed by CMO

Set up CMO/CPO company on network

Create TraceLink Admin User accounts and

CMO’s Company Admin accounts

Activate TraceLink accounts

Create Company Master Data for

CMO/CPO

Create case for NSMs to address integration

Verification Team Network Success Manager

Add CMO/CPO Company logo

Establish B2B connection with CMO/CPO (if applicable)

Add maps to company Schedule and conduct training with CMO/CPO

Contact brand owner to confirm set up is

complete


integration




MA

HC

MO

Trac

eLin

k





Specs Overview




integration




Assist with testing as needed

Note: If completed before, just contact NSM Receive TraceLink

Integration Completion Certificate


• Automated Validation Manager

• EdgeTrac

Continuous Compliance….

cmo-mah integration challenges & success...

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