GS1 standards provide a framework for identifying, capturing, and sharing supply chain information through barcodes and electronic data interchange. The presentation discusses how GS1 standards can be applied to ensure traceability, enable unique device identification (UDI) as required by the FDA, and provide real-time visibility through standards like EPCIS. It also outlines specific GS1 solutions for sectors like transportation and logistics, healthcare, and customs that leverage global standards to improve supply chain collaboration and efficiency.

1. GS1: Conformance Barcoding in Manufacturing
23/10/2013,
Vision ID Manufacturing

2. Agenda
• GS1 Standards Overview
– Identify
– Capture
– Share
• Barcode conformance in Context
– Unique Device Identification
• Identify
• Capture
• Share
• What Solutions can GS1 offer our members
– Traceability
– GUSI

3. Collaboration driving Standards adoption
Vision ID is currently implementing a Standards
based solution to become a certified solution
provider
• Implementing a Standards based EPC
Global/RFID enabled solution.
• Ensuring real time visibility of a companies
assets
• And more….

4. GS1 – ‘an unknown known’
Not-for-Profit
CostsANAI savings
and (1984)
shared by members
EAN (1997)
Neutral
…by
Speaking
GS1 (2005)
one
language
Global reach, Local Presence
User Driven
Member organisation
driving Global Standards
•
•
•
•
•
•
•
•
•
111 Member Organisations
150 countries served
20 Industrial Sectors
3,000 staff globally
1.5 million companies
3,000 companies in Ireland
40 Years experience
> 6 billion transactions daily
ISO, CEN, ETSI, UNECE based standards
4

5. GS1 Standards

6. The global language of business
GS1 Standards make it possible
to identify, capture, and share information automatically and
accurately about products, business locations, and more.
Allow organisations to focus on how to use the information
rather than how to get information
6

7. Identify: Gs1 Identification Numbers
GS1 Identification Numbers are used to uniquely distinguish all products (trade items), logistic
units, locations, assets, and relationships across the supply chain from manufacturer to consumer.
7

8. Capture: GS1 data carriers
GS1 Data Carriers are capable of holding varying amounts of data to accommodate different
needs such as batch/lot information and expiration dates.
8

9. SHARE: GS1 Data Exchange
Interoperability, made possible by identification standards, data capture standards, and
data exchange standards, allows product information to flow through the supply
chain.
9

10. Conformance???
10

11. What is required?
Barcode
Software
The GS1
General
Specifications
(Version 13)
A Printer
Regulatory
Documents
Other
documents,
Helpdesk,
Technical
Guide etc.

12. The FDA’sUnique Device Identification
Regulation
Not IF…
But WHEN
12

13. Unique Device Identification
1.
2.
3.
4.
A standardized system to develop Unique Device Identification numbers (UDI)
UDI in human readable and bar code/RFID on the device label
Data to be submitted to the UDI Database
Users need your help to implement. FDA expects GS1 to play a major role.
13

14. UDI system… overall System at a glance
UDI/UDID - System
UDID
UDI
(database)
• DI
Static Data
Elements
(static data)
• PI
(dynamic data)
• DI = primary access
key
•…
•…
AIDC
Machine –
readable Data
Carrier
• Linear Bar Code
• 2D Bar Code
• RFID
•…
DI = Device Identifier
PI = Production Identifiers
14

15. UDI: Purpose
A common, worldwide system for
product identification should eliminate
differences between jurisdictions and
offer significant benefits to
manufacturers, users and/or patients,
and Regulatory Authorities.
15

16. What is Driving the Need ?

Current systems of product catalog numbers include duplicate identifiers for the different products across
trading partners
Manufacturer
Description
Medtronic
305905
Mosaic ® 305 Porcine Heart Valve ………….
BD
305905
3mL BD SafetyGlide ™ Syringe ………..
J&J

Catalog #
305905
Protectiv ® IV Catheter System ………..
Current system allows product re-identification by every stakeholder in the
supply chain, making product tracking efforts extremely difficult
Manufacturer
Product # 305905
Distributor
Product # MT305905
Hospital or Healthcare Provider
Product # M-5905
Source, Jackie Elkin, Medtronic

17. Which barcode do we scan?

18. Unique Device Identification
UDI in the GS1 “AIDC World”
(Automatic Identification and Data Capture)

19. UDI
Unique Device Identification
...enabled by…
GS1 Standards !!
NOTE: At the time of this presentation the US FDA Ruling has just recently been
published. As it is in-depth, and there were some changes in the final Ruling from the
original proposed draft, it is recommended that you always refer to the final US FDA
Ruling for all details.

20. UDI system… overall System at a glance
UDI/UDID - System
UDID
UDI
(database)
• DI
Static Data
Elements
(static data)
• PI
(dynamic data)
• DI = primary access
key
•…
•…
AIDC
Machine –
readable Data
Carrier
• Linear Bar Code
• 2D Bar Code
• RFID
•…
DI = Device Identifier
PI = Production Identifiers
20

21. UDI in the GS1 System of Standards
DI =
GTIN: 5391234567892
PI =
EXP: 2012-10-03
LOT: ABCDEF123456
Ser: 1234567ABCDEF

22. UDI system… overall System at a glance
UDI/UDID - System
UDI
0
(database)
• DI
Static Data
Elements
(static data)
• PI
(dynamic data)
UDID
• DI = primary access
key
•…
•…
AIDC
Machine –
readable Data
Carrier
• Linear Bar Code
• 2D Bar Code
• RFID
•…
DI = Device Identifier
PI = Production Identifiers
22

23. US FDA Global UDI Database (GUDID)
• Global Unique Device Identification Database (GUDID)
– Operated by the FDA to collect information on Medical Devices
– Will have public facing website to share data with anyone (future)
• All medical devices which are regulated under the UDI regulations will be required to be listed in the GUDID
– Sunrise for each class is the same for GUDID as assigning a UDI
•
•
•
•
Class III devices- 1 year from release of GUDID web interface
Class II “life sustaining” devices- 2 years from release of GUDID web interface
Class II remaining devices- 3 years from release of GUDID web interface
Class I devices- 5 years from release of GUDID web interface
23

24. Source: FDA presentation UDI conference, Sept 2013
24

25. Source: FDA presentation UDI conference, Sept 2013
25

26. How
GS1 can help – Ireland’s National Product Catalogue
Source
internal
database
1
Source
datapool
2
2.
3.
3
GS1
Global
Registry
4
1.
3
Recipient
datapool
4.
5.
Load Data
–
The information supplier loads product and company information in its data pool
Register Data
–
A small subset of this data is sent to the GS1 Global Registry
Request Subscription
–
The information recipient, through its own data pool, subscribes to receive the information
Publish Data
–
The information supplier’s data pool publishes the requested information to the information
recipient’s data pool
Confirm & Inform
–
The information recipient sends a confirmation to the information supplier via each company's data
pool, which informs the information supplier of the action taken by the information recipient retailer
using the information
Recipient
internal
database
26

27. One connection to UDI databases, Providers
and other data recipients
Data is
provided
to the
FDA
GUDID by
the
Source
Data Pool
Manufacturers are able to provide data to all UDI databases and their customers
(hospitals, distributors, wholesalers, GPOs) simultaneously, with one single
connection.

28. NEW UDI webpage: http://www.gs1.org/healthcare/udi
The site will continue to be populated as more supporting documents are developed
28

29. EPCIS
Supply Chain Visibility

30. SHARE: GS1 Data Exchange
Interoperability, made possible by identification standards, data capture standards, and
data exchange standards, allows product information to flow through the supply
chain.
0
30

31. What is EPCIS ?
EPC Information Services (EPCIS)
•
GS1 / EPCglobal Standard since April 2007
•
Defines data formats, capture and query interfaces
•
Supplements classic EDI
•
Requires serialized or batch identification
• e.g. GTIN (object class) + serial number => SGTIN
•
Does not require RFID -> can also be used with bar codes
EPCIS is an enabling tool for supply chain transparency and event-driven
process optmization . . .

32. EPCIS Events at supply chain read points
WHAT
Individual object instances
(e.g. SGTIN, SSCC, GRAI...)
WHERE
•Read point (SGLN)
•Business location (SGLN)
WHEN
Time stamp of the event
(date + time + time zone)
WHY
•Business Step (e.g., Pick-Up)
•Disposition (e.g., In Transit)
...recorded as an EPCIS Event

33. EPCIS Capture of supply chain events
EPCIS Repositories
Event
Event
Event
Event
TransactionEvent
storage
commssioning
production
AggregationEvent ObjectEvent
shipping
WHAT:
SSCC 4001356.5900000817
WHAT:
SSCC 4001356.5900000817 4026800.010421.101
QuantityEvent
WHAT:
SGTIN 4026800.010421.101
GTIN
SGTIN 4026800.010421.101GTIN 4026800.010421
SGTINWHAT: 4026800.010421.102
4026800.010421.102
GTIN
SGTIN 4026800.010421.1025
WHERE: SGLN 4012345.01010.0
QTY:
bizTransaction: desadv 471150825
WHERE: SGLN 4012345.00040.0WHERE: SGLN 4012345.00031.0
WHEN: SGLN 4012345.00050.0
WHERE: 22.10.2009 09:25:00 UTC+1
WHEN: 23.10.2009 WHY: packing
13:40:00 WHEN:
UTC+1
WHEN: 23.10.200922.10.2009 11:20:00 UTC+1
14:47:00 UTC+1
WHY: commissioning

34. The EPCIS enables real time visibility
•
Tracking
•
Tracing
•
Pedigree
•
Authentication
•
Inventory
•
•
– Where are my objects now?
– Where were my objects last Tuesday afternoon?
– Which parties were involved (chain of custody)?
– Where has my object been along the way?
– Are my objects likely genuine?
– What is my current stock at one or more locations ?
Returnables
– Was the returned product legitimately purchased ?
Recall
1. Find impacted objects
2. Initiate recall
3. Follow recall progress

35. Conclusions

36. GS1: A Broad Portfolio
GS1 has active programs in several specific industry sectors.
Healthcare: In over 50 countries worldwide, GS1 standards have
been chosen to identify pharmaceutical products uniquely. Major
regulatory bodies have endorsed them, including those in the US,
Japan and the UK.
Defense: Global Solutions offered by GS1 play a role in the
defence sector including but not limited to procurement, logistics
and asset tracking. GS1 standards are endorsed by the North
Atlantic Treaty Organisation (NATO).
Customs Transport & Logistics: Today no transport and logistics
company can be efficient without robust information technology
and data communication support. GS1 standards help hundreds of
T&L companies.

37. GS1 Solutions
GS1 Solutions bring together
elements from the GS1
portfolio to address a specific
business need
A GS1 Solution is a set of elements from the GS1
portfolio that help companies resolve complex
business issues, using GS1 Standards, GS1
Guidelines, GS1 Services, and other GS1 Solutions.

38. Transport and Logistics
•
AIDC:
 Quick start guide: GS1 Identification Keys in Transport & Logistics for the use of
GS1 ID Keys in T&L
•
EDI (GS1 eCom):
 Standards for Transport Management available
 Implementation guides
 Standards for warehouse management under
development
•
EPC/RFID:
 support to RAIL project initiated by GS1 Sweden.
•
Regional projects:
Support and awareness of a range of regional projects including CASSANDRA,
eFreight, APEC Supply Chain Visibility

Leveraging global standards to reduce cost, complexity and support
interoperability across the industry
38

39. GS1 Upstream Integration
Improved collaboration between manufacturers and their
suppliers
• GS1 Upstream Integration Solution
Designed to address the challenges in supply chain integration and
collaboration between manufacturers and their suppliers.
• GUSI: Global Upstream Supply Initiative
A Working Group of The Consumer Goods Forum with
manufacturers from CPG/Retail and their suppliers. Collaborating
together to develop an upstream solution based on common scenarios,
common processes, common electronic messages – in order to reduce
complexity and implementation costs and create an exchange platform.

40. GS1 Global Traceability Solution
Expert guidance for improving your traceability system at the
lowest cost to meet regulatory and quality requirements
• GS1 Global Traceability Standard - a unique solution to
optimise the company’s traceability system based on
internationally recognised standards already used in most
supply chains
• GS1 Traceability Assessment – a service provided by GS1
Global Traceability Auditors to assess your company’s
traceability system and help you meet international
regulations
• Global traceability guidelines - for specific sectors
• Expertise, training & implementation support by local
GS1 organization

41. Contact Details:
Alan Gormley
Conformance and training Manager
E alan.gormley@gs1ie.org
T + 353 1 208 06 71
W www.gs1ie.org