1.
AbbVie OER - Serialization
Mary L. Gimenez – AbbVie Inc.
Gagan Bhasin – Krypt Inc.
SESSION CODE: HS2034

2.
§ Typical Pharmaceutical Product Serialization
Requirements
§ Fit/gap analysis with Aii and OER
§ Leverage Event Management in OER for Serial
Number Management
§ Aii can be optional in the Serialization
architecture
LEARNING POINTS

3.
§ Identify Stakeholders and decision makers
upfront during the project
§ Utilize ASAP methodology
§ Work Shops to walk thru current and future
Business Process flows
§ Evaluate available standard components
§ Use Service Oriented Architecture for Interfaces
to OER
§ Work as ONE team – from different areas
BEST PRACTICES

4.
AbbVie – A Broad and Strong Foundation
Medicines available in 170+ countries
19 R&D and manufacturing facilities
Portfolio of market-leading medicines
Compelling new product pipeline
$19.9 billion in 2014 sales

5.
A niche systems integrator in the Supply Chain space providing unique and high-value
solutions using SAP technologies like GTS, WM/EWM, TM, GRC, BI and HANA
Corporate
§ Founded in 2008
§ Team: 80+ in the US and 25+ in India
§ Presence throughout U.S. and in India; HQ in Santa Clara, CA
Customers
§ Serve companies in 35 countries, mostly Fortune Global 500
§ Over 95% of customers have been repeat customers
Financials
§ Privately held; 100% (YoY) revenue growth in 2013; annualized rate of 260% revenue
growth over past three years
Thought Leadership
§ Authored 6 books and 65+ white papers published by SAP Press
§ Invited to speak at business, industry, and SAP conferences, and expert round-tables
§ Continuous investment in R&D; co-innovation with SAP on GRC, SCM and Analytics
suite
About Krypt Inc.

6.
Discussion Topics
AbbVie’s
Product
Serializa4on
Objec4ves
Track
and
Trace’s
old
architecture
and
challenges
faced
Evalua4on
of
Aii
and
OER
Track
and
Trace’s
new
architecture
Func4onali4es
built
in
OER
Q
&
A

7.
Coding & Serialization Requirements
Global & US

8.
Issues & Opportunities
Pharmaceutical Supply Chain
Lack
of
Supply
Chain
Visibility
Compliance
Issues
High
cost
of
Recalls
Returns,
Shipment
inaccuracy
and
inefficiency
Track
Trace
Report
Assign
Track
&Trace
Needs
Issues
Warehouse/3PL
Distributor
Pharmacy/
Dispenser
Manufacturer
/
CMO
Supply
Chain
Par7cipants
Opportuni7es
Value
Apps

9.
Product Serialization

10.
AbbVie Product Serialization Objectives
Achieve
traceability
regulatory
compliance
Assure
supply
of
products
to
markets
Leverage
serializa4on
and
traceability
technology
to
achieve
business
value

11.
Discussion Topics
AbbVie’s
Product
Serializa4on
Objec4ves
Track
and
Trace’s
old
architecture
and
challenges
faced
Evalua4on
of
Aii
and
OER
Track
and
Trace’s
new
architecture
Func4onali4es
built
in
OER
Q
&
A

12.
Track & Trace’s old Architecture
PCE
AP5
(ROCIT)
Packaging Edge
Systems
Distribution
Edge Systems
Antares
Internal External
TPCM
AbboC
TPM
VeCer
TPM
Aesica
3PL

13.
Challenges faced
Isolated
Solu4ons
• Serial
number
management
and
regulatory
repor4ng
func4onality
cascaded
down
to
produc4on
lines
• No
visibility
as
there
is
no
object
event
capture
at
present
Extensive
Manual
Efforts
• Extensive
manual
work
in
place
for
China,
South
Korea
&
Turkey
• In
2015
need
to
meet
coding
&
serializa4on
requirements
for
Argen4na,
Brazil,
Saudi
Arabia
and
Taiwan
Difficult
to
comply
• DQSA
1/2015
deadline
to
provide
lot
level
traceability
including
TS,
TI,
TH
• Genera4on
of
randomized
serial
numbers
for
market
requirements
Failure to meet regulations impact our ability to sell products in specific markets.

14.
Discussion Topics
AbbVie’s
Product
Serializa4on
Objec4ves
Track
and
Trace’s
old
architecture
and
challenges
faced
Evalua4on
of
Aii
and
OER
Track
and
Trace’s
new
architecture
Func4onali4es
built
in
OER
Q
&
A

15.
Aii and OER Evaluation
Aii
• SN
Range
only
• Store
serialized
transac4ons
(XML/PML),
not
EPCIS
format
• Packaging
systems
had
Site
managers,
Aii
is
redundant
• Packaging
Edge
can
provide
EPCIS
data
format
• Not
an
Event
repository
OER
• EPCIS
Cer4fied
• Aii
Master
Data
in
OER
• Supports
SN
Range
• BRF+
(Rule
Engine)
• Event
Management
• Stores
and
manages
millions
of
object
id
events

16.
Requirement Gaps
Solution Alternatives
Alterna7ve
Approach
Enhance
Enhance
OER
Custom
development
Add-­‐on
Implement
SAP
Partner
add-­‐on
to
OER
Integrate
Implement
non-­‐SAP
Solu4ons
Leverage
Leverage
core
base
of
OER
–
Event
Management
–
to
resolve
gaps

17.
Event
Management
O E R
PI
AII
(Central
Service)
Event
Management
Event
Management
Typical
Implementa4on
• EPCIS
Event
Capture
No4fica4on
• EPCIS
Simple
Event
Query
• Std
Process
&
System
Integra4on
• Central
S/N
Range
Management
• ID
Mapping
• Vocabulary,
Master
Data
• Loca4on
Based
Security
• Object
Hierarchy
Event
Tracking
• Document
Tracking
• Web
UI
• Archiving
Event
Management
AbbVie
Implementa7on
• EPCIS
Event
Capture
No4fica4on
• EPCIS
Simple
Event
Query
• ID
Mapping
• Vocabulary,
Master
Data
• Object
Hierarchy
Event
Tracking
• SN
Get-­‐to-­‐go
(w
BRFplus)
• Archiving
Are
we
‘Modifying’
OER
by
doing
this?
Let’s
understand
‘What
is
SAP
EM’
to
answer
this.
Solution Alternatives
Leverage : SAP OER – Components & their functions

18.
Solution Alternatives
Leverage : SAP EM Flexibility
Are
we
‘Modifying’
OER
by
using
core
component
of
SAP
OER
–
Event
Management
–
for
Event-­‐based
S/N
Inventory
Tracking
?
No.
We
are
using
SAP
Event
Management
to
support
Company
Specific
Scenario.

19.
Object Event Management
Object Tracking = Managing Reservoir of Object & Event Information

20.
Discussion Topics
AbbVie’s
Product
Serializa4on
Objec4ves
Track
and
Trace’s
old
architecture
and
challenges
faced
Evalua4on
of
Aii
and
OER
Track
and
Trace’s
new
architecture
Func4onali4es
built
in
OER
Q
&
A

21.
Track & Trace’s new Architecture

22.
Discussion Topics
AbbVie’s
Product
Serializa4on
Objec4ves
Track
and
Trace’s
old
architecture
and
challenges
faced
Evalua4on
of
Aii
and
OER
Track
and
Trace’s
new
architecture
Func4onali4es
built
in
OER
Q
&
A

23.
Product Serialization
Processes
Commissioning
(Marriage
of
a
Number
to
a
Product)
SN
Get-­‐to-­‐Go
(G2G)
Produc4on
&
Packaging
Object
Tracking
(Commission
to
Dispense
–
C2D)
In
Scope
GS1 Implementation Guide for Pharma.: “EPCIS
is
a
GS1
Standard
for
capturing
and
communica4ng
data
about
the
movement
and
status
of
objects
in
the
supply
chain
(e.g.,
products;
logis4cs
units;
returnable
assets;
etc.)”

24.
Discussion Topics
AbbVie’s
Product
Serializa4on
Objec4ves
Track
and
Trace’s
old
architecture
and
challenges
faced
Evalua4on
of
Aii
and
OER
Track
and
Trace’s
new
architecture
Func4onali4es
built
in
OER
Q
&
A

25.
Q & A

26.
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27.
THANK YOU FOR PARTICIPATING
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provide
feedback
on
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session
by
comple4ng
a
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survey
via
the
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applica4on.
SESSION
CODE:
HS2034
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