gs1 digital link structure mswg lisbon physical meeting · jeanne duckett –avery dennison &...

Chairs, Phil Archer, Mark Harrison & Greg Rowe

GS1 Digital Link Structure MSWGLisbon physical meeting

12 September 2019

© GS1 2019

WiFi internet access

• Select network “Sheraton Lisboa” and connect

• Username: GS1events

• Password: GS1events

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© GS1 2018

Anti-Trust Caution

• GS1 operates under the GS1 anti-trust caution. Strict compliance with anti-

trust laws is and always has been the policy of GS1.

• The best way to avoid problems is to remember that the purpose of the group

is to enhance the ability of all industry members to compete more efficiently.

• This means:

- There shall be no discussion of prices, allocation of customers, or products, boycotts, refusals to

deal, or market share

- If any participant believes the group is drifting toward impermissible discussion, the topic shall

be tabled until the opinion of counsel can be obtained.

• The full anti-trust caution is available via the link below, if you would like to

read it in its entirety: GS1 Anti-Trust Caution

http://www.gs1.org/gs1-anti-trust-caution

© GS1 2018

Statement & Reminder for Seeking Intellectual Property Information

• Relevant to the features of the specification that are being developed in this

Work Group, if anyone has knowledge or information about intellectual property

rights, such as, patents or patent applications; please promptly convey this

information to the Work Group Facilitator.

• The intellectual property rights can either be in development or owned by

persons, companies or third parties within this WG or outside this WG.

• We do this under the guidance of the IP Policy, so that GS1 can seek to avoid

the uncertainty regarding intellectual property claims against the Specification.

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© GS1 2018

What's been happening

Standard

• Standard has finished public consultation now in IP review

Awareness

• Demonstration at GS1 Connect Denver (June) and Lisbon this week

Videos

• Four videos have been produced

Training

• Training materials are in Beta testing

- Training sessions set up in Asia region

Implementation Guide

• Sub-team Working session on the implementation guide (25th July)

• Implementation guide in draft

Use Cases

• We have started to see early addition of Digital Link which we will look at today

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© GS1 2018

Events we have attended

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© GS1 2018

The plan moving forward

We are reaching the end of the current phase

• GSMP Work Group – Produce the standards and Imp Guide

So What next – Typically we now move into implementation

• We need to review items for 1.2 of the standard

• We have to enable the MOs to educate and promote DL

• We also need to engage the Service Providers and Industry Sectors

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We will spend some time today looking at these

© GS1 2018

The agenda for today is therefore

1. Provide and update of where we are

2. Share experiences and viewpoints on DL

3. Review items for 1.2 of the standard

4. Take a look at the implementation guide

5. Start to look at the next phase of work

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© GS1 2018

The agenda for today is therefore

1. Provide and update of where we are

2. Share experiences and viewpoints on DL

3. Review items for 1.2 of the standard

4. Take a look at the implementation guide

5. Start to look at the next phase of work

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© GS1 2018

12 September: Agenda (morning)

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EST Topic

8:30-8:45 Welcome, Anti-trust and IP Statement & Reminder, Introductions

Topic 1: Experiences and viewpoints on GS1 Digital Link

Dom Guinard – EVRYTHNG

Tatjana Pathare – Roche

Jeanne Duckett – Avery Dennison & Jo Anna Stewart – GS1 US

Raad Ali, GS1 Jordan

Elizabeth Waldorf - Tracelink

10:30 – 11:00 BREAK

Topic 2: What’s coming up in GS1 Digital Link 1.2?

Lisa Sandberg – GS1 GO Marketing

Kevin Dean – Delegating Authority

Phil Archer – Standards ingestion model and semantics

Heinz Graf – Implementation in Switzerland

Grant Courtney – Regulatory oversight

12:30 – 13:30 Lunch

© GS1 2018

12 September: Agenda (afternoon)

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EST Topic

13:30 – 17:00 Implementation issues

Implementation Guide – progress so far. Paul, Grant, Phil

Review training deck – Phil

The view from the marketing department – Lisa Sandberg

Industry engagement options – do we need an MOIG?

Time line from now to End of 2020

Experiences and Viewpoints

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GS1 Industry & Standards Event 2019

September 2019 in Lisbon, Portugal

Tatjana Pathare, F. Hoffmann La Roche

About F. Hoffmann-La Roche

About F. Hoffmann-La Roche

• Company headquarters are located in Basel, Switzerland

• In 1934, it became the first company to mass-produce synthetic Vitamin C, under the brand name Redoxon

• In 1957 it introduced the class of tranquilizers known as benzodiazepines – brand names Valium and Rohypnol

• To present date we manufacture several cancer drugs

• Today Roche ranks among the world’s leading healthcare companies and has two strong core businesses: Diagnostics and Pharmaceuticals

• Frontrunner in personalised healthcare -With our combined strength in pharmaceuticals and diagnostics, we are better equipped than any other company to further drive personalisedhealthcare

FIRST AND FOREMOST HURDLE

EDUCATION DIFFERENCE BETWEEN THE 2 CODES

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GS1 DataMatrix GS1 QR codeVerification? Information?

Which code should I scan to get the relevant information on a single item?

QR Code

GS1 DataMatrixBarcode

1D Barcode

GS1 DataMatrixBarcode

QR Code

Folding box

Vial label

MOST COUNTRIES WOULD LIKE TO IMPLEMENT THE QR CODES ON THE PATIENT INFORMATION LEAFLETS

TeaserUse the existing barcode on the folding box and label so that the end users can use this code to get digital information

Linking to verification as protection against counterfeitingLinking to information about the product (videos, audios, illustrations, texts…)Information on Recall, Expiry Date, Tamper Evidence feature

GTINBATCHEXPEventually Serial Number

SCOPE

• USE DIGITAL LINK

• USE GS1 STANDARD

• USE existing1D CODE

and if available

• 2 D DATA MATRIX BARCODE

What do you require?

• An app to scan the 2D Data Matrix code (some countries have their own apps / some solution providers)

• GS1 Digital Link standard

• Resolver

• Database containing the information (e.g. e-compendium.be; felleskatalogen.no)

CHALLENGES WE FACE NOW

BUILD A ROCHE APP

NO GENERAL APP EXISTING IN MARKET


DATA BASE

If it exists (external companies) can we use it?

If it does not exist who will provide the affiliates with

• Patient Information in xml format? Many Health Authorities are using the pdf format and many companies are using pdf on their websites

• If it exists one language for 3 territories ?

• Where do we store ‘other’ information ?

e.PI(Felleskatalogen)

Other info


Resolver

GS1 Resolver or Company based Resolver or Country based Resolver

Who does what ?

Work on-going

Could we leverage GDSN to feed Digital Link Resolvers?

• What does the Resolver need as minimuminformation?

– GTIN

– Language

– Territory

– Link Type

– URL of the source content

• What GDSN could provide?

– GTIN

– GLN of the informationprovider

– Target Market

– And many other data

Source: GS1

ManufacturerCould this also be a Resolver??

THINGS ARE GOING FAST - NOW THAT WE HAVE THE BUY IN FROM SOME COUNTRIES

• NO PILOTS

• JUST IMPLEMENT !

Doing now what patients need next

© GS1 2018

Our Road to Digital Link

Preparing Products for Consumer Internet of Things (C-IoT)

Jo Anna Stewart – GS1 US and Jeanne Ducket – Avery Dennison

© GS1 2018

Agenda

• GS1 Overview

• GS1 C-IoT Research Summary

• GS1 Digital Link – Connecting Products

• Digital Link Proof of Concept Work

• Digital Link Demo

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© GS1 2018 31

The Identification of Everything

Makes Anything Possible

© GS1 2018 32

GS1 Standards: The Global Language of Business

• Pioneer

- 40+ year history transforming the way we work and live with U.P.C. and RFID

• Expertise

- Most widely used system of standards in the world

• Reach & Impact

- Over 2.5 million businesses

- 6 billion scans daily

- 112 member organizations representing 120 countries

© GS1 2018

C-IoT GS1 Research Summary

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© GS1 2018

Consumer Internet of Things (C-IoT)

We hypothesized that GS1 has a role in the C-IoT

space because:

• A globally unique persistent identity has a role in consumer

interaction beyond the point of purchase.

• Standards have a role to play in the messaging between a thing

and a consumer.

• Standards have a role to play in post purchase.

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© GS1 2018

Consumer Internet of Things (C-IoT) Research

2018 research proved our hypothesis to be TRUE!

• Looked at Core/Advanced Business Drivers as well as Architecture

Components

• GS1 determined our continued focus in this area should remain

centered on the GS1 identity, capture, and share mission and the

application of that mission to C-IoT

• Led to industry support to do proof of concept work focused on

more granular, web-resolvable, identity for ‘things’ – which is a

building block for C-IoT

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© GS1 2018

What GS1 Looked At

Core Business Drivers

• Product Information

• Product State

• Provenance/Chain of Custody

Advanced Business Drivers

• Dynamic Product Delivery

• Consumer Engagement

• Compliance

• Replenishment

• Customization

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Architecture Components

• Data Carriers

• Digital Identity

• Authentication and

Authorization

• Data Modelling and Vocabulary

• Specific Services

• Payment

© GS1 2018

Future of Retail Research

Drivers to Expand Data Encoded on Pack

Results from GS1 US and VDC Research across Tier 1 retailers and brand owners:

• Inventory Accuracy

• Improved Consumer Engagement

• Freshness/Waste Prevention

• Returns Management

• Product Authenticity

• Traceability

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© GS1 2018

Current State

Current State

• 1D U.P.C. barcode that limits

available information at the class

level and limits consumer

engagement

• Starting to see multiple data

carriers per pack, utilizing

proprietary formats, to better

engage with consumers and provide

additional information

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© GS1 2018

Future Vision

• A single data carrier on pack

utilizing a standard format,

providing value to the brand,

retailer, and consumer that

also works at POS

• Access to brand authorized

sources of information by all

with the ability to customize

experiences for consumers

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Future Vision

© 2018 GS1 US All Rights Reserved

GS1 Digital Link:Connecting Products

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45 years ago…

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© 2018 GS1 US All Rights Reserved 42

Problem 1:

The birth of the connected consumer

© 2018 GS1 US All Rights Reserved 43

Problem 2:

Supply Chains & Data ecosystems are complex and costly.


GS1 Digital Link: Potential Value

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GS1 Digital Link has the opportunity to help transform current labeling into an efficient, empowering platform for retailers & consumers that can enable limitless linked information, improve data latency, and more.

Reduces Label Types

Multiple barcodes on label

Single barcode on label

DataMatrix QR Code

or

Simplifies Data Sharing Ecosystems

Retailers aggregate data

Retailer link to data sources

Links to Additional Information

Limited product info & use cases

Limitless product info & use cases (product

origin, ingredients, etc.)

Extends Uniqueness

Identical codes on 1D labeled products

Unique codes on all products

Removes Data Latency

1 Day refresh rate

Real time refresh

© Avery Dennison 2019

Digital identity means that

products have a fingerprint.

T O D A Y

© Avery Dennison 2019

Products will have more than a fingerprint; they’ll

have a birth certificate and a digital life that consumers

will interact with!

T O M O R R O W

Transparency for Food Service - Building Trust in the Food Supply Chain | Classification: Avery Dennison - External

AVERY DENNISON® | PRINTER SOLUTIONS

GS1, WalMart P&G Proof Of Concept Digital Link

Transparency Matters to Consumers● Impact on Business: The research findings make a direct connection between

transparency and commercial benefit for brands. More than three quarters of shoppers say they are more likely to buy food products that make available information beyond what appears on a physical label. Moreover, more than seven in 10 shoppers say they are willing to switch from their usual brand to one that provides more in-depth information beyond what appears on the label.

● Trust and Loyalty Impacted: Transparency from brands has a direct impact on building consumer trust and boosting loyalty, according to shopper feedback. About half of shoppers are even willing to pay more for a product that offers more in-depth product information beyond what is on the physical label.

53% of consumers are willing to pay more for transparency 75% said they would switch brands for a more transparent brand

https://info.labelinsight.com/




Transparency Matters to Suppliers

• Boston Consulting Group Dec 2018: 0.8% of annual revenue is wasted due to friction

• Average Food Item12 different IT systems other than excel – only 3 are interoperable

Transparency for Food Service - Building Trust in the Food Supply Chain | Classification: Avery Dennison - External © Avery Dennison 2019

The Global Language of Business



TRANSPARENCY FOR FOOD SERVICE

What’s in my food?

Where did my

food come from?

How was it farmed?

Did they avoid

harsh chemicals?

Were the animals and

people treated fairly?

Was the planet

taken care of?

THESE MACRO TRENDS HAVE

SEVERAL SIMILARITIES






Where are we coming from?2018 USA Multistate Outbreak of E. coli: Romaine Lettuce

2 DISTINCT OUTBREAKS IN 2018

Affected Restaurants and Retailers may not have know where their lettuce came from

March 2018

Case Count: 210

States: 36

Deaths: 5

Hospitalizations: 96

Recall: No

Outbreak over Jun 28, 2018

Nov 2018

Reported Cases: 62

States: 16

Hospitalizations: 25

Deaths: 0

Recall: Yes

Outbreak over Jan 9, 2019






– Transparency Valued: FMI & Label

Insights

– 93 percent consumers

‣ What is in food

‣ How it’s made

Consumer Trust –

How do we achieve it




Why?

I scanned an organic cauliflower UPCA barcode with my

phone…

I came up with a page describing it:

https://www.upcindex.com/73574820008

https://www.upcindex.com/73574820008




Today this information is not controlled by retailer or

brand owner!




Another site that told me inventory levels at major retailer

https://brickseek.com/walmart-inventory-

checker?sku=44391028 … Very soon you will also be able

to see traceability information.

Why?

https://brickseek.com/walmart-inventory-checker?sku=44391028




Inventory levels at stores not controlled by the retailer

COMPANIES ARE ON A DIFFERENT PLACE ON THE

TRANSPARENCY PATH





GS 1 Digital Link Proof of Concept

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Goals of the Proof of Concept

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• Show the value of more granular identity across the retail

ecosystem, and across physical and digital commerce.

• Show relevance and develop a value proposition for each

stakeholder including Suppliers, Retailers, Consumers, and

Technical Providers.

• Demonstrate the ability of standards to increase value today and

to set the foundation for more advanced use cases into the future.

• Define and share next steps and increase industry support for

needed changes that are identified through the demo.


POC Focus Areas and Use Cases Demo’d

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Focus Area Demonstrate

Distribution Center • ASN Verification

• Product State

• Hazmat information

Retail Store –

Back Room

• Reduce counterfeit product

• FIFO/Date for product rotation

• Expired product

• Recalled product

• Hazmat/Safety

Retail Store Shelf / POS • Recall by batch vs. all

• Recall POS stop sale by batch

• Expired product stop sale

Consumer at Home • Hazmat/Safety

• SmartLabel

• Reorder

• Expired product


A Quick Demo

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Getting a GS1 Digital Link Working Demo Ready

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GS128 Case Label read as a DL

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• Technology now affordable and ubiquitous

• Less distinction between physical and digital world: “weird that it

doesn’t work”

• Change in consumption of technology in companies

• PAST: companies worked with specialized integrators for specific,

customized solutions

→ resulting in: islands of incompatible data everywhere in the

organization

• NOW: seek technology providers that can pull together business-

relevant solutions based on open standards and architectures

→ resulting in: consolidation of data islands

GOALS:

• Un-interrupted flow of data

• Increased productivity, efficiency, flexibility, and agility

→ Faster decision making process

The number of connected “things” in the world has

skyrocketed from about a million in the early 1990s to 13

billion today; . . . Expect to see 50 billion connected

devices by 2020.

Information based decisions, leading to action, aided by machine learning and

analysis of data autom. collected locally or remotely by connected “things”

• Right decisions only possible if data is

accessible

• Product data and information has to be

collected, tracked and traced when it

traverses the supply chain

• Class Level product identification levels not

granular enough for supply chain visibility

• Batch level data does not provide the level of

information needed to track products through

the supply chain and minimize risks

Unique identification KEY to track and access data; protect

brands & customers

GS1 Digital Link - the Golden Age of Digitization

WHY NOW?

GS1 GLOBAL UNIQUE IDENTITIES

Source: Cisco


To Summarize - In the FUTURE:

Every product could be:

1. Self describing

2. Its own media channel, personalised to

a consumer

3. Its own authoritative source of

information

Every scan could:

1. Tell you when and where it was scanned

2. Whether the scan was by a known

customer (and if so who)

3. What else they scanned

One barcode could:

1. Do everything, everywhere

2. Support B2B and B2C functions

3. Remove the need to aggregate multiple

sources of data


Thank You!

66


Contacts

• Jeanne Duckett

• Transparency Solutions Design

• 937 672 3182

• [email protected]

67

• Jo Anna Stewart

• Director, Business

Analysis and Program

Management

• 615.268.7023

• [email protected]

Kevin Dean, Special Projects Consultant, GS1 Canada

GS1 Digital Link

Resolver and Beyond

June 17, 2019

Copyright © 2019 GS1 Canada

Problem Statement

• Multiple parties will have data about any given product

• Data may be tied to…

- A product

- A group of products (e.g. by GS1 Company Prefix)

- A category of products (by GPC brick, family, class, or segment)

• Data may be provided by…

- The brand owner

- Industry

- A regulator

- An interested party

69


Declarations

• Any party can declare that they have data of interest

• In order for data to be trusted, it must be known to have come from

party authorized to provide it

• Untrusted data may still be valuable, but some data must be trusted

• Trusted data needs a chain of trust

- Chain must have a well-known, trusted starting point

- Each link in the chain must declare that the next link is authorized to

provide data

- Declarations may be made in any order, provided that the chain is

complete

• Declarations may be suspended or revoked, breaking the chain

70


Vocabulary

• Need a vocabulary to establish a chain of trust and to declare that a

party has data of interest

• Each imperative verb needs an optional parameter to undo the

operation

• Operations can be expressed in any order by individual parties (i.e.

chain of trust is valid as long as all parties in the chain make the

appropriate declaration regardless of the order) but operations

within a party are treated sequentially

71


Vocabulary – Grant

• Used to grant permission to make declarations associated with a range

• GS1 Global Office grants itself permission for the entire range (*)

• GS1 Global Office grants GS1 Member Organisation permission for its

GS1 Prefix range (e.g. 754*)

• GS1 Member Organisation grants GS1 Member permission for its GS1

Company Prefix (e.g. 754123*)

• GS1 Member Organisation grants another permission for its GS1

Company Prefix (e.g. GS1 US Alliance) or subrange of its GS1 Prefix

(e.g. GS1 UK prefixes given to Irish companies before the formation of

GS1 Ireland)

• Have to include flag to prevent further grants (i.e. prevent GS1 Member

from subdividing its GS1 Company Prefix)

72


Vocabulary – Declare

• Used to declare a URI for a service associated with an identifier or

range

• Some services (e.g. product recall) may require a chain of trust

whereas others (e.g. product review) may not

- Chain of trust may be established by simple chain of grants from

GS1 Global Office

- Some services may require additional permission for declaration

from outside agency (e.g. regulator) over and above GS1 chain of

trust

73


Vocabulary – Delegate

• Used to delegate declare authority from GS1 Member to a Solution

Provider

• Delegation may be for all possible services or a limited list of

services

• Delegation must be at the GS1 Company Prefix or individual GS1

identification key level

74


Vocabulary – Suspend

• Used to suspend a previous grant, declare, or delegate operation

• Undoing the suspend returns everything as it was before

- Useful for suspending services for a GS1 Member that is behind in

license payments

75


Data Interaction

• Interaction model must be standardized

- How to request data (GET)

- How to provide data (POST)

- How to invalidate data (callback)

• Data model must be standardized

- Standard format

- Well-defined attributes

- Access to a descriptive schema

- Support for localization

76


Context and Security

• A declaration that data is available doesn’t mean that it is accessible

- May be sensitivity even in declaring the link itself

• Context defines what is accessible

- Security (role)

- Connectedness (proof of chain of custody)

- Location

- Language

- Device

- etc.

• Service providing the data may return different subsets depending on

the context in which the query is made

77


Building a Resolver

• Ability to make declarations should be open and should not require

GS1 membership

- Blockchain?

- Distributed Identity?

• Resolver should be able to read all declarations and build a lookup

table based on well-defined rules

• Some resolvers may not support untrusted data

- That is an implementation choice

• Resolvers can be chained together so that private or industry-

specific resolvers can defer to public resolver for non-specific

queries

78


Public vs. Private Declarations

• For this to work, all declarations will have to be public

• Highly sensitive products (e.g. narcotics) may have to self-limit the

declarations they make

• Won’t be able to do traceability with this due to known problems

with business intelligence in the declarations

• Should satisfy 90% of use cases for access to services and data

79


Use of Web Vocabulary

• Link types that reference schema.org or GS1 web vocabulary

provide well-defined data sets for ingestion by client applications

and should be encouraged

• Link types referencing human-readable pages (e.g. gs1:pip,

gs1:nutritionalInfo) are useful for humans but hard for client

applications to understand

• Use of web vocabulary will allow client applications to present data,

even if they don’t understand it

80


Parking Lot

• Regulators may prohibit specific link types within their market

- e.g. Cannabis in Canada may not be allowed to provide marketing

links

- In this case, the regulator should provide the mapping from their

attribute to the GTIN in a way that is accessible to the resolver

• Regulators may want to suspend brand owners’ ability to declare

links

- e.g. Brand owner’s content is out-of-date or links are broken,

regulator suspends ability to declare links until issues are resolved

• Regulators may require specific link types to be satisfied by specific

resolvers

81


Parking Lot

• Declarations need to handle full and partial mergers and

acquisitions

- Full is easy (done by the MO), partial is hard

• Support for other identification schemas is out of scope for GS1 but

solution should not explicitly bar them

- Generic solution based on Linked Data could conceivably support

any identification schema

82


Contact Information

GS1 Canada1500 Don Mills Road, Suite 800Toronto, Ontario M3B 3K4Canada

Telephone:

Email:

www.gs1ca.org

+1 416-775-9821

83

[email protected]

Kevin Dean

Special Projects Consultant

Raad Ali, Senior Technical Specialist

Ahmed Bataineh, Head of IT Department

GoScan

Product Catalogue – GS1 Digital Link

GS1 GSMP –12 September 2019

Lisbon, Portugal

© GS1 Jordan 2015

GoScan Project – Phase 1

1. Online Member Management platform

2. GoScan Search Engine

3. Pilot Project with 50 member companies

85

© GS1 Jordan 2015

Online Member Management platform

• Prefix managements

• More than 500,000 product record

• 13 attributes (7 mandatory attributes + Sub Brand Name + Sub Sub Brand + Level of

Packaging + Gross /Net Weight + Product Dimensions)

• Provide photography and measurement services

• Enabling planogram and marketing images

• Print barcode and other services

New developments

• Barcodes number management

• Marketing channel

• Enabling data analysis / data quality

86

© GS1 Jordan 2015

GoScan - Why?

• Develop new services for member companies

• Provide services for non-member Companies

• A platform to collect product images & information

• Improve GS1 Jordan’s capabilities

• Create a platform/search engine to promote Jordanian products

87

© GS1 Jordan 2015

GoScan Objectives

• A platform to help companies adding product information and marketing materials

• Bringing GS1 Standards to life

• A trusted source of data

• A tool to share / exchange Product information

• A search engine to promote companies and their products

• Enabling Mobile Applications

• Enabling members data analysis

88

© GS1 Jordan 2015

GoScan Pilot Project

• 50 companies participate in this pilot project.

• Food, Detergents, cosmetics, paper and paperboard, Plastic, Cosmetics and pharmaceutical.

• 5 products from each company in this pilot

• Project process:

✓ Check physical Product

✓ Product data entry (Attributes + promotional materials)

✓ Product photography and photo editing

✓ Check Data quality

✓ Company approval

89

© GS1 Jordan 2015

Product Search

90

© GS1 Jordan 2015

Company Search

91

© GS1 Jordan 2015

2 Languages English - Arabic

92

© GS1 Jordan 2015

GS1 Digital Link

93

• GTIN + GLN

• GS1 Jordan data source

• Capture Barcodes (EAN/UPC + QR CODE )

• through mobile app

• View information

© GS1 Jordan 2015

Web Search Engine Result by [GTIN/GLN]

94

© GS1 Jordan 2015

API Result by GLN [Device to Device]

95

© GS1 Jordan 2015

API Result by GTIN [Device to Device]

96

© GS1 Jordan 2015

GS1 Digital Link

97

Opportunities Challenges

Technical advantages • Web Search engine/product• Mobile app• RESTful API

• Our source of data.• Discussions with regulatory

bodies to mandate barcode on Jordanian products.

• GoScan Pilot project with 50 companies.

• Healthcare work group.

• Completeness and quality of data.

• Companies Lake of awareness of importance of data quality.

• Limited investment in technology.

• Different used technology.

Elizabeth Waldorf

U.S. Pharmaceutical Application of GS1 Digital Link for VRS Implementations

12 September 2019

© GS1 2018

TraceLink

© GS1 2018

A Family of Integrated

Information Sharing SolutionsA Network of

Digital Information

Sharing Solutions

© GS1 2018

GS1 Standards enable us to seamlessly interoperate, our network of supply chain stakeholders depend on industry’s adherence to standards.

Integrate Once, Interoperate with Everyone

102

• Traceability is a multi-party, multi-chain challenge.

• Alignment and collaboration with supply chain partners is essential.

• Open supply chain standards enable interoperability between all

parties by establishing a common set of rules for identification, data

capture, data sharing and data usage.

• The GS1 System of Standards is an integrated suite of global standards

that provides supply chain visibility through the accurate identification,

capturing, and sharing of information regarding products, parties,

locations, assets, and services.

© GS1 2018

Manufacturer(Nov. 2017 + enforcement

disc.)

Repackager(Nov. 2018)

WholesaleDistributor(Nov. 2019)*

Dispenser(Nov. 2020)

Serialization May only transact (buy/sell) with product that has been encoded with a product identifier**• Grandfathered product is granted an exemption from these rules

Verification Product is determined to be suspect or request for verification received from FDA, etc.• Promptly conduct investigation in coordination with trading partners• Validate applicable T3• Verify product identifier at the package level

SaleableReturn

Verify product identifier for sealed homogeneous case or saleable unit before resale.

Request for Verification

Verify product identifier within 24 hours**• Request for verification from any authorized

trading partner (repackager, wholesale distributor, or dispenser)

Aggregation Not DSCSA legal requirement**

U.S. DSCSA Phase 2 Regulatory Requirements

* No official enforcement discretion has been announced for upcoming Nov. 27, 2019 requirements

** Trade partners may require/request additional requirements beyond DSCSA legal requirements (such as sub-second response time)

© GS1 2018

Regulatory ComplianceDSCSA requires verification & interoperability

• Verification Requirements

a) Saleable Returned Product:, Under DSCSA §582 ( c) (4)(D), beginning November 27, 2019, wholesaler distributors are required to verify the product identifier including Standardized Numeric Identifier (SNI) of products returned to them before the returned products can be placed into inventory for resale.

- DSCSA defines verification as the process of “determining whether the product identifier affixed to, or imprinted upon on a package or homogeneous case corresponds to the [SNI] … assigned to the product by the manufacturer or the repackager….” [§ 581(28)]

b) Suspect or Illegitimate Product Investigation: Enhanced Verification requirements for manufacturers (2017), repackagers (2018), wholesalers (2019) and dispensers (2020) require them to “verify the product at the package level including the standardized numerical identifier”

• Interoperability

- The Enhanced Drug Distribution Security Requirements effective November 27, 2023, stipulates system interoperability and compliance with recognized international standards.

- “Systems and processes for verification of product at the package level, including the standardized numerical identifier, shall be required in accordance with the standards established under the guidance issued pursuant to subsection (a)(2), paragraphs (2), (3), and (4) of subsection (h), including any revision of such guidancesissued in accordance with paragraph (5) of such subsection, which may include the use of aggregation and inference as necessary.” Sec. 203, [§ 582(g)(1)(C)]

- Supply chain parties are expected to exchange information in “a secure, interoperable, electronic manner in accordance with the standards established under the guidance issued pursuant to paragraphs (3) and (4) of subsection (h), including any revision of such guidance issued in accordance with paragraph (5) of such subsection.” Sec. 203, [§ 582(g)(1)(A)]. “The form and format of exchanges shall comply with widely recognized international standards development organization.” Sec. 203, [§ 582(h)(4)(A)(i)].

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© GS1 2018

Regulatory Pharmaceutical Business Use Case

• Each year, circa 60 million saleable units are returned to wholesale distributors

in the US supply chain **

• Per the Drug Supply Chain Security Act (DSCSA), receiving companies must

verify the product identifier prior to resale

• NDC (GTIN), Serial, Lot, and Expiry *

• For serialized products, manufacturers and repackagers are required to

Respond to verification requests from supply chain participants as of Nov 27,

2019 *

• Verification of Saleable Returns – Verification Router Services (VRS)

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** HDA Saleable Returns Pilots Report 2017

© GS1 2018

General Verification Router Service (VRS) Model

Manufacturer(Responder)

Distributor(Requestor)

Dispenser

VRS

LookupDirectoryVRS

LookupDirectory

The GTIN in the request acts as a key in the Directory to tell me where to send the

request.

Sync

Verification Response

Verification Request

Manufacturer populates the

Directory with GTIN, identity, and connectivity information.

Serialized Product

Serialized Product

Saleable Returned Product

© GS1 2018

PIM Product Verification - TraceLinkCapabilities for Successful DSCSA Verification

Business Requirement TraceLink Capabilities

• Provides an API for receiving and responding to a request

• Provides a user interface for request / response

• Authenticates the system that is making the verification request

• Verifies the requesting business is legitimate and valid

• Supports HDA VRS Task Force and GS1 Verification Messaging Standard for Lookup Directory and Verification Request/Response interoperability

• Automated publishing of GTIN information to approved industry Lookup Directories

• Supports automated and user interface verification

• Authenticates the solution provider making the verification request

• Verification of requestor GLN to ensure legitimate business entity

© GS1 2018

GS1 Lightweight Messaging Standard for Verification of Product Identifiers

• Driven by urgent DSCSA Saleable Returns requirement for Nov 2019, the standard is designed for global sector use as a generic lightweight framework that will support use and extension by other industry sectors or other country regulatory jurisdictions

• Specifies a standardized, simple “lightweight” messaging framework for verification request and receiving actionable response

• Enables the requestor to determine whether to accept, reject, or quarantine the product

• First standard to leverage the new GS1 Digital Link syntax

• Release 1.0 – December 2018

• Release 1.1 - July 29, 2019

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Learn more - https://www.gs1.org/sites/default/files/docs/standards/gs1_lightweight_verification_messaging_standard_v1-1.pdf

https://www.gs1.org/sites/default/files/docs/standards/gs1_lightweight_verification_messaging_standard_v1-1.pdf

© GS1 2018

GS1 US Implementation Guideline - Applying the GS1 Lightweight Messaging Standard for DSCSA Verification of Returned Product Identifiers

• The purpose of this document is to assist the U.S. pharmaceutical industry in implementing the GS1 Lightweight Messaging Standard to support DSCSA product identifier verification for returned products.

• It provides essential technical information including localization query parameters and settings, the open API schema, configuration and set-up, verification requests, and verification responses.

• Release date - July 29, 2019

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Learn more - https://www.gs1us.org/documents?Command=Core_Download&EntryId=1897

https://www.gs1us.org/documents?Command=Core_Download&EntryId=1897

© GS1 2018

GS1 Verification Messaging - Requestsuse of linkType to request specific type of information service

110

https://example.com/gtin/00361414567894/lot/1908642E/ser/400806?exp=170728&linkType=verificationService&context=dscsaSaleableReturn&corrUUID=21EC2020-3AEA-4069-A2DD-08002B30309D&reqGLN=0321012345676

Verificationrequest

(configured for DSCSA

Saleable Returns)

GS1 Digital Link( GTIN, Lot, Serial Number, Expiry Date )

linkType=verificationService

context=dscsaSaleableReturn

corrUUID=21EC2020-3AEA-4069-A2DD-08002B30309D

reqGLN=0321012345676

PositiveVerificationResponse

NegativeVerificationResponse

OR

© GS1 2018

Verification Responses

• JSON syntax will be used to Respond to all verification requests.

• Verification Responses SHALL, at a minimum indicate...

- Responder GLN

- Correlation GUID indicated by the requestor in the original Verification

Request

- Whether the request was verified (true) or not verified (false)

- Where NOT verified, indication as to whether the reason for non-

verification ("verificationFailureReason") was...

• "No_GTIN_and_Serial_match": No matching SGTIN

• "No_Lot_match": No matching Lot

• "No_Expiry_match": No matching Expiry

• "No_reason_provided" _

•

111

© GS1 2018

Interoperability is not a dream….it’s a REALITY

We can meet compliance requirements and achieve interoperability by collaborating and agreeing to use GS1 data standards!!!

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© GS1 2018

Contact Information

113

Elizabeth Waldorf

Director, Global Traceability & Standards

[email protected]

TraceLink, Inc.

400 Riverpark Drive

Suite 200

North Reading, MA 01864

www.tracelink.com

+1 818 203 9080M

E

http://www.tracelink.com/

GS1 Digital Link

...an experience from Switzerland

GS1 Switzerland, Heinz Daniel GRAF

12 September 2019


The use case in Switzerland

116


The system

117


The use case in words

Value

• Speed

• Process automation

• Process quality

• Food Safety

• Food quality

• B2C communication

• M2M communication

GS1 inside

• QR Code with GS1 Digital Link

• AI Standard

- AI(01)

- AI(15) - phase II

- AI(21)

- AI(91) - programming parameters

118


The actual content of the QR Code

https://dt.sisisi.com/01/07640342960117/21/4294967295?91=13,15,15,3,3,100,

55,0,0,0,0,70,0,HASH

https://dt.sisisi.com

/01/07640342960117

/21/4294967295

?91=13,15,15,3,3,100,55,0,0,0,0,70,0,HASH

119

https://dt.sisisi.com/01/07640342960117/21/4294967295?91=13,15,15,3,3,100,55,0,0,0,0,70,0,HASH


The benefit of the use case

One single symbol serving two purposes:

• B2C communication

- ingredients

- nutrition facts

- allergens

• M2M communication

- programming parameters for steaming

120


Contact Information

121

Heinz Daniel GRAF

Senior Standards Expert

+41 58 800 72 00

www.gs1.ch

[email protected]

GS1 Switzerland

Monbijoustrasse 68

CH-3007 Berne

+41 58 800 72 29

+41 79 356 45 77

T

D

M

E


One small scan for a man, one giant leap for mankind.

© GS1 2018

The EU FMD - EMVS

124

2. The unique serialised number is uploaded into the medicines verification system

4. The Genuine product is

provided to the patient

3. The 2D barcode will be scanned prior to dispense and the serial number verified, to ensure

the pack is authentic.

1. The manufacture will generate and apply the unique serialised number to

the package in a 2D barcode

© GS1 2018

Regulatory Oversight – EU FMD Example

Article 31 - Establishment of the repositories system

• 1. The repositories system where the information on the safety features shall

be contained, pursuant to Article 54a(2)(e) of Directive 2001/83/EC, shall be

set up and managed by a non-profit legal entity or non-profit legal

entities established in the Union by manufacturers and marketing

authorisation holders of medicinal products bearing the safety features.

© GS1 2018

Article 44 - Supervision of the repositories system

1. National competent authorities shall supervise the functioning of any repository physically located

in their territory, in order to verify, if necessary by means of inspections, that the repository and the legal

entity responsible for the establishment and management of the repository comply with the requirements of this

Regulation.

2. A national competent authority may delegate any of its obligations under this Article to the competent

authority of another Member State or to a third party, by means of a written agreement.

3. Where a repository not physically located in the territory of a Member State is used for the purpose of

verifying the authenticity of medicinal products placed on the market in that Member State, the competent

authority of that Member State may observe an inspection of the repository or perform an independent

inspection, subject to the agreement of the Member State in which the repository is physically located.

4. A national competent authority shall communicate reports of supervision activities to the European Medicines

Agency, which shall make them available to the other national competent authorities and the Commission.

5. National competent authorities may contribute to the management of any repository used to identify

medicinal products and verify the authenticity of or decommission the unique identifiers of medicinal products

placed on the market in the territory of their Member State.

National competent authorities may participate to the management board of the legal entities managing those

repositories to the extent of up to one third of the members of the board.

126

© GS1 2018

What learnings are there from EU FMD

• Authorities will allow industry to operate systems but we should expect them to want

oversight, this oversight may include:

- Access the system

- Reports from the system

- Involvement in the management of the system

- Auditing

- Hosting content

• They will be more likely to allow the use of GS1 Digital Link if they are able to check it is

being used correctly and the content is appropriate and control to address if it is not

• Systems will have to meet quality standards (e.g. Tested, Documented, Secure, etc)

129

© GS1 2018 131

Geek ?

?by Adriano

cc-b

y-n

c-n

d

https://flic.kr/p/hGuK1

https://www.flickr.com/photos/95228277@N00/

https://creativecommons.org/licenses/by-nc-nd/2.0/

© GS1 2018

We can ask for All the links for this example:

132

https://id.gs1.org/gtin/614141123452/lot/ABC1/ser/12345?exp=180426

© GS1 2018

‘All’ the links for this example:

• Resolvers ignore the query string – that’s just attributes that don’t tell you

anything about identity

133

https://id.gs1.org/gtin/614141123452/lot/ABC1/ser/12345

© GS1 2018



• Add any links for this batch/lot, e.g. recall info, traceability info

• Add any links for this GTIN, e.g. product information page, instructions,

promotions and more

136


© GS1 2018

For every Primary Key

137

Explosion by Carlos Bustamante Restre cc-by-nd

https://flic.kr/p/oarD1e

https://www.flickr.com/photos/fuchales/

https://creativecommons.org/licenses/by-nc-nd/2.0/

© GS1 2018

We need

• A method to upload links that makes sense for GCP licensees

• Include rules, matching things like batch/lot numbers and serial numbers

138

© GS1 2018 139

Questionin

gby J

ohn S

am

uelcc-b

y-n

c

?exp=201225

https://flic.kr/p/TCDnym

https://www.flickr.com/photos/gramachree/

https://creativecommons.org/licenses/by-nc/2.0/

© GS1 2018

Considerations

Against

• Making links conditional on an attribute goes against design principles

• Adds another layer of complexity to the data for each record in a resolver

• Requires real-time processing by the resolver (currently not necessary) – heavy

impact on performance

• Where does it stop?

For

• We have a clear use case to do so

• It’s not uncommon

140

Takin a look at the GS1 Digital LinkImplementation Guide

Greg Rowe – GS1 Global Office

14

gs1 digital link structure mswg lisbon physical meeting · jeanne duckett –avery dennison &...

Documents