Serialized track and trace. Is it a requirement you need to conform to or need?

A member of The Business Maturity Group
Solutions to Business Problems
Serialized track and trace. Is it a requirement you
need to conform to or need
May 23rd, 2013

copyright © 2013 Q Data USA, Inc. All rights reserved.
a member of The Business Maturity Group
Q Data SAP EM Webinar Series
 May Theme: Solutions to Business Problems
Thursdays at 11am CST
1. How can you pay suppliers more promptly thus being eligible for
those terms discounts? (5/9)
2. How can you ensure that your sensitive products leaving your care
are ultimately tracked and returned as expected? (5/16)
3. Serialized track and trace. Is it a requirement you need to conform
to or need? (5/23)
4. Vendor Compliance, scorecards, EDI, Procure to Pay, ASN and Supply
Chain Maturity! Scary or Logical? (5/30)
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Throughout this webinar
What is the weather like over there?

Agenda
 Vocabulary
 Standards
 Components
 Regulations
 Wrap-Up and Questions

Chain of Custody (CoC)
It is a legal term that refers to the ability to
guarantee the identityand integrityof
the sample / product (and data) from the point
of origin to the final destination…
A Definition

Chain of Custody (CoC)
What does it look like? THE PLAYERS…

Chain of Custody (CoC) – Part 1/3
How do we uniquely identify a product?

“A permanent unique mark on an object,
designed to be scanned and interpreted
digitally, identifying the object individually”
Unique Identification (UID)
When you can uniquely identify an item and exchange information about the item
in a standard format you can electronically track that item giving …
You improve data quality, inventory control, enable rapid fraud detection,
Provide visibility from cradle to grave, …

Item Unique Identification (IUID)
• Spawned by a DoD (2003) mandate for
improved item management:
•Is the most mature of all the UID initiatives
•Is currently the focus for SAP Solutions
•Is usually a 2-D barcode; it may be an RFID tag
Construct 1: Items that are
serialized within the enterprise
identifier
Enterprise ID + Serial #
Construct 2: Items that are
serialized within the part, Lot or
batch within the enterprise
Enterprise ID + Part # + Serial #
www.bpn.gov/IUID
In concert with RFID technology
• IUID can provide the “what”
• In addition to the RFID “where”

Electronic Product Code (EPC)
• provides a universal unique, serialized
identifier for any kind of object
• GTIN (Global Trade Item Number)
• GRAI (Global Returnable Asset Identifier)
• SSCC (Serialized Shipping Container Code)
• GIAI (Global Individual Asset Identifier)
• SNI (Standardized Numerical Identifier) – FDA Pharma
• The EAN/UPC bar code, which encodes GTINs,
provides identifying information for a class of item
• EPC goes beyond this when a GTIN is encoded in an EPC by identifying an
individual serialized item or instance of the item (sGTIN).
• Two cases of the same product will have the same GTIN, but will have different
EPCs (sGTIN).
The EPC structure is defined by the EPCglobal Tag Data Standard…
www.gs1.org/epcglobal

National Drug Code (NDC)
• Unique ID provided to permit automation of
processing of drug data between government,
drug manufacturers and distributors, hospitals
and insurance companies
• 1972: Mandatory for all prescription and OTC drugs
• 2004: Mandatory linear barcodes on drug packages
• Contains:
• FDA Labeler code, Product Code, Package size (10 digits)
An NDC…
“…provide an identification system in computer language to
permit automated processing of drug data by Government
agencies, drug manufacturers and distributors, hospitals, and
insurance companies” (from 34 FR 11157, July 2, 1969).

Global Trade Item Number (GTIN)
• an identifier for trade items by GS1
• comprising among others of the former EAN International and
Uniform Code Council (UCC)
• used to look up product information in a database
• GTINs may be 8, 12, 13 or 14 digits long
• Company Prefix, Item Reference and a calculated Check Digit
GTIN-14 adds another component- the Indicator Digit, which can
be 1-8
Global Trade Item Number (GTIN) is …

• Barcode: “Optical machine-readable
representation of data, which shows
data about the object to which it
attaches.”
• 2-D Barcode
• Linear Barcode
Barcode

GTIN, UPC and EAN
 GTIN-8s will be encoded in
an EAN-8 bar code
 GTIN-12s may be shown in
UPC-A, ITF-14, or GS1-128
bar codes
 GTIN-13s may be encoded
in EAN-13, ITF-14 or GS1-
128 bar codes
 GTIN-14s may be encoded
in ITF-14 or GS1-128 bar
codes
• Universal Product Code
(UPC) dominant barcode
standard in North America
 encodes a 12 digit number
(GTIN-12) which allows it
to be scanned and read in
almost any retail store
• The EAN-13 and EAN-8 are
other point of sale barcodes
that are widely used outside
of North America.
 A UPC can be transformed
into an EAN by prefixing it
with a zero

Data Matrix vs. QR Code – 2D
Data Matrix
• Developed in 1989
• 2,335 alphanumeric characters
• Considered more secure
• Cannot handle Japanese
characters
• 22 x 22 (10 x 10, … 144 x 144)
• 17% recognition area
• More compact
QR (Quick Response)
• Developed in 1994
• 4,296 alphanumeric characters
• Accommodates Japanese
characters
• 29 x 29 (21 x 21, … 177 x 177)
• 27% recognition area

• “… is a technology that incorporates the use of
electromagnetic or electrostatic coupling in the
radio frequency (RF) portion of the electromagnetic
spectrum to uniquely identify an object, animal, or
person.”
• Active Tag:
• Requires a battery, antenna, more expensive, great
distances, larger, shorter life, cheaper readers
• Passive Tag:
• No battery, coiled antenna, less expensive, short
distances, smaller, last longer, fixed readers
Radio Frequency Identification
Technology (RFID)
RFID:

• Example applications of RFID:
• Security access
• Item and asset management
• Ticketing and baggage tracking
• Toll collection
Technology (RFID) (cont.)
• Inventory RFID tags can be applied to:
Cases PalletsItems

UID Data Matrix (Item Level)
Technology (RFID) (cont.)
RFID tags that carry data can be attached to packages at multiple levels, including
item packages, cases, and pallets. Unique Identifiers can be attached or directly
marked on items using a data matrix to carry the UID data elements.
• Linking UID with RFID
RFID Tag (Pallet Level)
RFID Tag (Case Level)
RFID Tag (Item Package Level)

RFID vs. Barcode
RFID advantages vs. barcodes
Category RFID Barcode
Line-of-Sight Not required Required
Security More difficult to copy Easy to copy
Environment/
Ruggedness
More tolerant of humidity,
water, …
Susceptible to
environmental conditions
Sense/record/transmit Active/Passive No read/write capability
Distance Can be read at greater
distances (up to 300 feet)
Needs to be much closer
(less than 15 feet)
Read rate Can read tags much faster
(40+ tags/sec)
Much slower, requires line
of sight (1/2 sec to read)
Reusability Usually protected by an
outer shell or imbedded in
the product
Limited due to exposure to
wear and tare (for line-of-
sight reasons)
Expense Usually much more
expensive
Cheaper to apply

Pedigree and ePedigree
• “A drug pedigree is a statement of origin that
identifies each prior sale, purchase, or trade of a
drug, including the date of those transactions and the
names and addresses of all parties to them.”
• The U.S. Food and Drug Administration (FDA) in the
2006 Compliance Policy Guide for the Prescription Drug
Marketing Act
• “An ePedigree is simply an electronic document
which satisfies a pedigree requirement. The primary
purpose of an ePedigree is to protect consumers
from contaminated medicine or counterfeit drugs.”
Chain of Custody

Chain of Custody (CoC) – Part 2/3
How can we get all players to play nicely with each other?

Standards
• Pharma trading partners need to adopt
several standards to address e-Pedigree
• SNI (Standardized Numerical Identifier)
• Moving towards adopting this standard for all drug
packages as part of the e-pedigree law
FDA Standards
Pursuant to Business and Professions Code section 4034, the “unique identification
number” established and applied to the smallest package or immediate container by the
manufacturer or repackager shall conform to the Standardized Numerical Identifier
(SNI) set forth in the Guidance for Industry published by the U.S. Food and Drug
Administration (FDA) in March 2010, consisting of a serialized National Drug Code
(NDC) identifier (or equivalent product identifier for dangerous drugs for which no NDC
has been assigned) combined with a unique numeric or alphanumeric serial number
that is no more than twenty (20) digits or characters in length.

Standards
• GLN (Global Location Number)
• Unique ID of locations and
legal entities
• 13 digit numeric
• GTIN (Global Trade Item Number)
• Helps automate buying and selling
• 4 constructs – 8, 12, 13, 14
• Contains info on the Item itself
GS1 Standards

Standards
• EPCIS
• Enables sharing EPC data between disparate
applications (across enterprises)
• GDSN (Global Data Synchronization Network)
• Not currently used in the US pharma supply chain
• Built around several GS1 standards including the
GS1 Global Registry® and data pools
• Secure & continuous synchronization of data
• Changes in DB are immediately synched with all
companies you do business with
GS1 Standards

Electronic Product Code
Information Services (EPCIS)
• EPCglobal® is leading the development of industry-driven
standards for the Electronic Product Code™ (EPC) to support
the use of Radio Frequency Identification (RFID) in today's
fast-moving, information rich, trading networks
• The goal of EPCIS is to enable disparate applications to leverage
Electronic Product Code (EPC) data via EPC-related data sharing, both
within and across enterprises
• What information can be shared via EPCIS standards?
• The What, Where, When, and Why of events occurring in any supply chain is
exchanged, safely and securely, via the EPCIS standard
• This is important business information, such the time, location, disposition, and
business
EPCglobal®

Components
• Serialized product – CoC Part 1/3
• To be able to Track and Trace it
• IUID, sGTIN
• Tag / Marking – CoC Part 1/3
• Unique readable marking of the product
• Standards – CoC Part 2/3
• All partners talk the same language
• ECPIS
What do we need to look at in order to provide an e-Pedigree?

Components (Ctd.)
• Solution – CoC Part 3/3
• Reader / Scanner : RFID / Barcode
• Repository – Store the data : SAP AII / SAP OER
• Query mechanism – Read the data : SAP PI / OER
• Trust? – CoC Part 4/3!!!
• What you say is in the box is actually in the box
• Inference
What do we need to look at in order to provide an e-Pedigree?

SAP Solutions for Auto-ID and
Item Serialization
Auto ID Infrastructure
Enables and manages Auto-ID-Enabled
Operational Processes integrated with ERP
at local/regional level and SAP OER
SupplyChainEdgeApps
AutoID
Infrastructure
EnterpriseApps
ObjectEvent
Repository
Object Event Repository
Provides Enterprise level Event-driven
Traceability and Visibility Applications

SAP Solutions for Auto-ID and Item
Serialization (cont.)
Auto-ID-Enabled Business Process
Automation
Item serialized Product, Part, Asset, and
Hierarchy Life Cycle Traceability
 Auto-ID-Enabled Outbound Processing
 Auto-ID Enabled Inbound Processing
 RFID-Kanban
 Returnable Transport Items
 Extensible to other ERP document
integration
SAP AII SAP OER/EM
 Product Tracking and Authentication
 Returnable Transport Items
 Linear barcode
 2-D barcode
 Passive/Active RFID
 Sensor events: Conditions, temperature,
locations
 GS1/ EPCglobal EPCIS – certified conformance to
EPCIS Standard as an EPCIS Repository
 [Beyond this OER can be easily extended to
custom attributes, vocabularies, etc.]
 GS1/EPCglobal Tag Data (TD) Standard
 GS1/EPCglobal TD Translation Std.
 US DOD Guide to Uniquely Identifying Items
 Beyond this AII can be easily configured to
other unique ID schemes
Domain
Core Solution
Standard
Processes
and Beyond
AIDC Support
Standards
Support
Hardware
Integration
in to App Store the Data

Delivery
System integration services: Value generation with RFIDPhysics and device expertise
Partner SAP &
Partner
Readers
Process
integration
Cross-system
traceability
SAP
OER
Edge Execution +
Enterprise
Applications
Read, write, and transmit
data to systems
Manage multiple
readers
Cleanse data
Operator workflow
Translate raw data to
business execution +
Decision support and
execute transactions
Enrich Object Event
Management Data
Enable
Tracking and Tracing
Function
Device
Management
SAP
ERP
Solution Landscape
SAP ITS mobile
Partner
Device
Mngt
Solution
SAP &
Partner
SAP &
Partner
SAP
Value Add
Partners
Value Add
Partners
SAP
AII
SAP
NW PI
Capture
Query

SAP Auto-ID Infrastructure (SAP
AII) (cont.)
• Immediate
• Verification
• Real-time Delivery and Shipment
verification – Data verification at
point of capture
• Anti-counterfeiting
• Product instance authentication
• Visibility
• Enterprise and Supply Chain wide
• Stretches to all Business Partners
securely
• SAP ERP transaction automation
following AII data capture
• More efficient shop-floor operation
without line of site data capture
through RFID sensing
• Intrinsic
• Instance item life cycle tracking
• Business data information sharing
based on granular levels (EPCIS)
• Events, business context,
instance IDs, dispositions
• Single version of truth: State
and history (pedigree)
• Web-service based standardized
B2B data discovery (EPCIS
compliant)
• Real-time business-contextualized
event-based data captured
• Extending enterprise data to the
capture of real-world raw events
• Unique IDs issued for the lifetime of
the products and assets – enabled
Pedigree
Business Value

AII) (cont.)
• EPC/Serial number range
management
• EPC hierarchy management
• ePedigree data provisioning
• Unique ID schemas
• EPC
• IUID
• Custom
• Delivery document integration
• Undo (Useful when you need to
undo one event for an item that is
part of a hierarchy)
• Generic document interface
• Master data management
• User interface
• Mobile and Desktop
• EPC enriched ASN
• EPC capture notification
• Store and forward – Delta queue
– Scalable
• Tag commissioning and
management
Functionality

AII) (cont.)
Translating raw Auto-ID events into business context
Auto-ID Raw Events
Business Processes
Repository
Translation
Logic

SAP Object Event Repository (SAP
OER)
• EPCIS-level enterprise level solution that
• Serves as the system of record spanning the life cycle of uniquely
identified objects across distributed systems
• Allows object related search
• Provides UI & query mechanism for business partner collaboration
• Tracks life cycle & conditions relating processes, hierarchies, parts &
assets
• Provides process monitoring, proactive alerting, reporting capabilities
• Integrates with
• SAP ERP for Business Process Tracking (procure-cash, delivery tracking,
transportation, etc.)
• Auto-ID Infrastructure that pushes Auto-ID events into OER
• Third-party Auto-ID Edgeware systems can be integrated with the EPCIS
standard event capture notification interface
Functional Domain

• Tracking of serialized items and hierarchies
• Where is this particular item?
• Tracking attributes and serialized item characteristics
• Batch #
• Expiration dates
• Authentication of IDs
• Valid hierarchy
• EPC
• EPC/Attribute combinations
• Data discovery services
• Business Docs, HU
• Product/part IDs
• Qualified events
• Attributes
OER) (cont.)
Capabilities

OER) (cont.)
• Movements Across Locations
• Show shipping durations
between different
locations across the
supply chain
• Movements at Location
• Show processing
durations at a location
• Proof of Receipt
• Check if an object was
received at any other
subsequent location
• Supply Chain View
• As-Built Configuration View
• Life cycle “Current“ Configuration View
SAP NetWeaver BW Reports for OER

-
SAP OER stores
hierarchies between
objects along their
entire life cycle
OER) (cont.)
Hierarchy Tracking

Regulations
• California
• part of the California Business & Professions Code
• When?
• 2015: 50 % manufacturer’s products
• 2016: 100% manufacturer’s products
• July 1 2016: Wholesalers and repackagers
• accept and forward products maintaining e-pedigree
• July 1 2017: Pharmacy and pharmacy warehouses
• accept and pass e-pedigrees
What is being forced in and by when?

Counterfeit Version of Avastin in U.S.
Distribution
“Roche conducted laboratory tests that confirmed the counterfeit version of Avastin.
Packages or vials may be counterfeit if they:
• are labeled with Roche as the manufacturer
• display batch numbers that start with B6010, B6011 or B86017
The only FDA-approved version of Avastin for use in the United States is marketed by
Genentech (a member company of Roche). The FDA-approved version does not
include the Roche logo on the packaging or vials. In addition, Genentech’s FDA-
approved version of Avastin vials and packaging have a 6-digit numeric batch number
and expiration dates in a 3-letter month and 4-digit year format (e.g., JAN 2014).
Genentech’s Avastin products are safe and effective for their intended uses.
The 19 medical practices in the United States purchased unapproved cancer medicines
and, potentially, the counterfeit Avastin, from…”
http://www.fda.gov/Drugs/DrugSafety/ucm291960.htm
Egypt  Switzerland  Netherlands  UK  US  Pharmacy
(Where else did the product go?)
FDA: Statement Issued: Feb. 14, 2012

Regulations
Describing how e-pedigree could help…
according to the California Pedigree Law, any
supply chain participant must be able to
produce a full pedigree for any package of
drugs in their possession at any time….
Not Allowed to
manufacturer drug!
OR
Drug already in
circulation!!!
1. Register product (Own Serial # or Copied)

Regulations
No info of serialized
drug!
2. Check product1. Skip registration

Regulations
No info of serialized
drug!
3. Check product1. Skip registration
2. Skip check

Regulations
Good to Dispense!
1. Registration 2. Check 3. Check 4. Check 5. Check 6. Check

Regulations
• Fully Centralized
• Single instance of track and trace repository
• Requires global cooperation / policing !!! Viable?
• Semi-Centralized
• Multiple central track and trace repositories
• China, Turkey, Italy, Brazil
• Fully Distributed / Decentralized
• Communicate with up/downstream partners - EPCIS
• Communicate with previous partners individually
• Different models per country / dependency!!! Viable ?
3 e-pedigree models under consideration

Summary
• What are the keys to being able to track your
serialized products?
• UID, EPC global standards, labels, readers,
events, application integration
• Understanding the discussion points around
RFID and Bar-codes
• Advantages: Line of site, distance to read,
expense, read/write
• Passive vs. Active
Some key points to take home…

Summary – CoC Part 1
Serialized product with tags / markings (Barcode / RFID Tags)

Readers / Scanners using Global Standards

Global Repository and Secure Query Mechanism

More Info
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Webinar series on Business Issues – May 2013
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Blog for Q Data by Kevin Wilson
“SAP Event Management – SAP’s best kept secret”
available at Amazon.com or Genie Press at http://www.geniepress.com/qdata

Questions???
Some of Q Data’s SAP EM related Clients
Kevin Wilson
Principle SAP Solution Engineer
kwilson@qdatausa.com
www.qdatausa.com

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