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Serializaton Overview Brand Protection Through
Serialization and Authentication
January, 2016
ABOUT US
© 2015 Systech International. Last updated August 2015 2
EXPERIENCE
30 YEARS EXPERIENCE
1ST GLOBAL SERIALIZATION DEPLOYMENT TRUSTED BY 19 OF TOP 20 PHARMACEUTICAL COMPANIES
OVER 1000 TOTAL CUSTOMERS
INNOVATION
ONLY PROVIDER OF 5-LEVEL STACK
PATENTED CONFIGURABLE SOFTWARE
PATENTED UNIQUE AUTHENTICATION IP
RECOGNIZED LEADER IN SOFTWARE DEVELOPMENT
RELIABLITY
1400+ ACTIVE LINES
RAPID AND CONSISTENT DEPLOYMENTS STANDARDIZED AND CONFIGURABLE
GLOBAL REACH
FULL GLOBAL COVERAGE
>50% OF BUSINESS OUTSIDE USA
ROBUST PARTNER NETWORK
SERIALIZATION TRACK & TRACE REQUIREMENTS
© 2015 Systech International. Last updated August 2015 3
Argentina Unit Serialization Jan ’12 – 1st phase products
Jan ’13 – Additional products
Jul ‘13 – Additional products
Jan ‘14 – Additional products
Jul ‘14 – Additional products
ANMAT System with aggregation for
high-volume products
United States Manufacturers Jan ’15 – Lot-Level traceabilility and
verification of lot info
Nov ’17 – Unit Serialization - unit
and homogenous case
2023 – Track & Trace
European Union Unit Serialization Q1 ’19
Pharmacy Verification
Ukraine Unit Serialization Jul ’15 – Expecting 2-yr delay
Algeria Unit Serialization Jan ’14 – Expecting 2-3-yr delay
Brazil Track & Trace Traceability – buyer/seller
Dec ‘13 – Resolution No.
RDC-54
Dec ‘15 – 1st of 3 batches
due
Dec ’16 – All
products/batches due
SERIALIZATION TRACK & TRACE REQUIREMENTS
© 2015 Systech International. Last updated August 2015 4
Turkey Track & Trace Jul ’10 – Serialized DataMatrix
Jan ‘12 – Traceability – MoH
system
Jordan Unit Serialization Jan ’17
Saudi Arabia Mar ’15 – Lot-level DataMatrix
Mar ‘17 – Serialized DataMatrix
TBD – Track & Trace pending
China Track & Trace (code 128c) ’11, ’12, & ’13 – In effect for EDL
’15 – In effect for all drugs
CFDA System
Mandatory unit/case aggregation
Veterinary Products (QR-
Code) ’15 – Vaccines
’16 – All veterinary Products
South Korea Jan ’13 – Lot-level DataMatrix
Jan ’15 – 30% Serialized
DataMatrix
Jan ’16 – All Products Serialized
DataMatrix and Track & Trace
Likely
India Unit- and case-level
serialization
Exports and
government sales ‘13-’15 – Systems pending
EU consensus serialization model
© Systech International | 2015
Pharmaceutical
Manufacturer and
Parallel Distributor Wholesaler Distributors Pharmacist Patient
Risk-based
verification
by Wholesale
distributors
National System 1 - n
Product
#
Batch
Expiry
S/N
European
Hub
Verification
upon
dispense to
Patient
Upload Data
TI/TS/TH Data Exchange Model
• 2015 TI/TH/TS – ASN856 following HDMA Guidelines • Paper or Electronic – Electronic Preferred
• FDA delayed enforcement for manufacturers, repackagers and wholesale distributors until May 1, 2015, and dispensers until November 1, 2015
• 2017 – Addition of serial numbers following GS1 standards, including EPCIS. Data Exchange transition from ASNs to EPCIS through 2022
• Electronic Required
Track & Trace captures data at
each step in the supply chain
across partner boundaries
Data captured and saved at each step
Manufacturer Packaging Wholesale distributors Dispenser
© Systech International | 2015
RDC-54 Track & Trace
I. Unique Identifier of
Medicine (IUM)
II. CNPJ (tax registration
number), business
name, address and
state of the companies
or establishments that
received the medicine
III.CNPJ, business name,
address and state of
transport companies
IV.Date and nature of the
movement of each of
the transactions in the
supply chain
V. Identifier code of
transport packaging CMO/CPO
AVISA
500 Manufactures - 7 Wholesalers - 51,000 Pharmacies
Manufacturer Wholesaler Pharmacist Dispenser
EPCIS
Product
Serialization
Database
EPCIS
Product
Serialization
Database
© Systech International | 2015
Classic Mindset
Produce a large number of identical units
With Serialization
Uniquely identify each unit
Associate items to their parents
SERIALIZED PRODUCT TRACKING
8 © 2015 Systech International. V1.2
SOLUTION
© 2015 Systech International. Last updated July 2015 9
Implement a serialization solution that:
Provides serial number range management
Serial number validation
Meets regulatory compliance
Can be upgraded and re-configured
Integrates with existing or new hardware
Deploys rapidly and scales with the business
Adapts to packaging and regulatory changes
Remotely supportable without having to wait
for an engineer to arrive
LEVEL 1 | DEVICE
LEVEL 2 | LINE
LEVEL 3 | SITE
LEVEL 4 | ENTERPRISE
LEVEL 0 | VERIFIED
LEVEL 5 | AUTHENTICATION
Serialization Architecture
Multi-Line Plant Operation
Standardization – modular implementation
Core Software Platform – base set of software/functions
used for serialization, independent of the packaging line.
Packaging Modules – reusable applications
Hardware selection
Core Software Platform
Guardian
Advisor
In-Lot Rework
Manual Palletizing
Post Lot Rework
Central Palletizing
Transfer Shipment
SAP Aii Interface
MES Interface
Level Packaging Integration Module
Item
PIM 110 – Carton Print & Verify
PIM 130 – Bottle Serialization on a Rotary Labeler
PIM 131 – Bottle Serialization on a Rotary Labeler with Top Code Association (Oriented)
PIM 132 – Bottle Serialization on a Rotary Labeler with Top Code Association within
Labeler (Oriented)
PIM 133 – Bottle Serialization on a Rotary Labeler with Top Code Association (Un-
oriented)
PIM 134 – Bottle Serialization on a Rotary Labeler with Bottom Code Association
(Oriented)
PIM 135 – Bottle Serialization on a Rotary Labeler with Bottom Code Association within
Labeler (Oriented)
PIM 136 – Bottle Serialization on a Rotary Labeler with Bottom Code Association (Un-
oriented)
PIM 140 – Bottle Serialization on an In-Line Labeler
PIM 141 – Bottle Serialization on an In-Line Labeler with Top Code Association (Oriented)
PIM 142 – Bottle Serialization on an In-Line Labeler with Top Code Association (Un-
oriented)
PIM 143 – Bottle Serialization on an In-Line Labeler with Bottom Code Association
(Oriented)
PIM 144 – Bottle Serialization on an In-Line Labeler with Bottom Code Association (Un-
oriented)
SOLUTION SUMMARY
PACKAGING INTEGRATION MODULE 110
CARTON PRINT & VERIFY
Advantages of approach
Stable solutions that meet business and customer requirements through the use of standards library
Enforce consistency across global deployments through the creation of methodologies and processes
Enable speedy and more efficient deployments through the use of document templates and pre-built configurations
Support rapid global scalability by providing Direct (Systech) and Indirect (Partners) a structured, defined approach to deployments
Maintain customer satisfaction post-implementation by providing quality manuals/documentation
POST-LOT CAPABILITIES
13 © 2015 Systech International. Last updated July 2015
TRULY SCALABLE – ADD AS YOU GO…
FLEXIBLE Singular, All Encompassing Foundation – add processes, steps, reconfigurations and
more..
Adaptable - Avoid costly reconfigurations
Palletizing – Automated / Manual & Centralized
Lot & Batch – Suspend & Resume
Reworks (Sandbox)
ONLY ONE with streamlined, centralized
operations within the same system
STORAGE, WAREHOUSING & REWORKS
14 © 2015 Systech International. Last updated July 2015
SINGULAR INTEGRATION – REDUCED DATA ENTRY
Easy integration
WMS, SAP, JD Edwards, QAD
Test integrations in a Sandbox environment
Stand alone operation
Doesn’t require any other software
Build as you go – Deploy today and add more for tomorrow…
Storage, rework, batch records and shipping preparation
Systech is the ONLY ONE to provide a single
point of integration without a 3rd party vendor
QA RELEASE AND SHIPMENT
15 © 2015 Systech International. Last updated July 2015
DATA INTEGRITY – VALIDATION - PREPARATION
ENABLES - Final Line/Site Operation
Shipping prep, QA testing, Release, Shipment
Track-and-Trace ready
Seamless upgrade to UniTrace
Integrates with 3rd party Level 4
PROVEN, SCALEABLE, RELIABLE Platform
Infinite # Lines
Infinite # sites
Supports all number formats
Regional and Global options
ONLY ONE delivering a complete serialization
solution stack with Track-and-Trace
Aggregation
Pallet
Case
Bundle
Unit
© 2015 Systech International. V1.2
VALUE OF AGGREGATION
In logistics (e.g. FedEx, UPS), can you imagine scanning every single bottle/carton
at every stage of the supply chain?
The only logical option is scanning only the cases or pallets.
If only the larger packages were serialized, there would be no tracking of the actual
unit of sale.
Without an association of units to parents, we do not have full Track and Trace with
information about where the units are at every stage of the supply chain.
17
Packaging Packaging WH Distributor Wholesaler Dispensation
© 2015 Systech International. V1.2
SOLVE CHALLENGES
Serialization Data exchange Serial number generation & management Third parties & Multiple suppliers EPCIS repository
Track & Trace Validate source content at production Visibility and reporting of supply chain
movement Exception handling support
© 2015 Systech International. Last updated August 2015 18
Manufacturing / Packaging Distributor Wholesaler Pharmacy
WHERE DO WE START?
When planning for a new deployment, several high level questions need to be
asked beyond the mechanical operation of the packaging equipment and what
levels require serialization
Which products?
Which markets? Which Regulations?
Which Production Lines?
How long will the line(s) be down?
How much will it cost? What resources are required?
How is the serialization data going to reach the supply chain?
19 © 2015 Systech International. V1.2
Know the regulations that pertain to each market. Different markets pose different
requirements.
Some markets require serialization of all pharmaceuticals.
Some markets’ serialization requirements only cover particular classifications of
products (e.g., prescription medication).
Some markets require 2D Data Matrix codes with specific information encoded in
them in addition to specific human-readable data.
Some markets require inclusion of a National Reimbursement Number or application
of labels for similar purposes.
Some markets have specific inspection requirements, not just printing and
serialization, that may only apply to some products.
WHICH MARKETS?
20 © 2015 Systech International. V1.2
The same product may exist in different forms based on the market and its
marking and/or serialization requirements. These variations should all be
considered different presentations of the same product.
MARKETS: PRODUCTS
21
Data Matrix
2 dimensional
Small footprint
Image reader decoded
Widely adopted by pharma
Code 128 Barcode
1 dimensional
Larger footprint
Widely supported in supply
chains by laser scanners
Required in China
QR Code
2 dimensional
Smaller footprint
Image reader decoded
China and baby
formula
© 2015 Systech International. V1.2
PUTTING TOGETHER THE FULL SET OF REQUIREMENTS
The basic requirements must include:
Volume and speed of production
A detailed as-is process
A detailed to-be process
“Must-have” functions
Integration requirements to packaging line (communication, signaling, controller
programming, reject handling, additional hardware including Serialization hardware)
Exception handling
Security access
22
REQUIREMENTS: DATA MANAGEMENT IN THE SUPPLY CHAIN
23
Serialization at the packaging stage is only the beginning, put together the
requirements needed for managing the data beyond the packaging line
Volume of data based on production
Communication with distributors and logistics operations
Data visibility and monitoring
Managing Rework
Security of the data
© 2015 Systech International. V1.2
DEPLOYMENT MANAGEMENT: DATA COLLECTION
Proper deployment requires solid information:
Think of a serialization deployment as an ERP/MES installation; it will affect several
departments (e.g., QA, Production, Warehousing, IT).
The configuration depends on the information provided (i.e., Garbage In Garbage
Out).
The amount of data needed is huge and may involve research and communication
with multiple sources.
Project delays can occur if Product and Market information need to be redefined in
the field.
Getting the correct data in the later stages of the project multiplies the effort and the
time lost.
24 © 2015 Systech International. V1.2
FINAL WORD
Take an active role in the
implementation of the systems and
make the effort to be involved. There
will be changes, and the best way to
manage them is to be as informed as
possible to maximize the value of your
investment.
Communicate, Communicate,
Communicate!
25 © 2015 Systech International. V1.2
ONLY ONE TO DELIVER
© 2015 Systech International. Last updated August 2015 26
SERIALIZATION, TRACK & TRACK, AUTHENTICATION & ENGAGMENT
GLOBAL AND REGIONAL SOLUTIONS FOR ALL KNOWN REGULATIONS
PROACTIVE UPDATES TO SUPPORT REGULATION AMENDMENTS
ADAPTABLE AND RECONFIGURABLE FOR CHANGING BUSINESS NEEDS
GLOBAL DELIVERY TEAMS AND CERTIFIED PARTNERS WITH PROVEN EXPERIENCE
POST IMPLEMENTATION SUPPORT AND TRAINING 24x7x365
PROVEN INNOVATOR WITH PATENTED TECHNOLOGIES
THANK YOU
www.SystechOne.com
© 2015 Systech International. Last updated August 2015
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