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.
Leveraging UDI Database Requirements to Drive Data GovernancePTC
Delivered at the event “UDIs and Traceability for Medical Devices 2014” in Munich, May 21 – 22, 2014, Europe's only UDI-dedicated event for the medical device industry – with keynotes from the FDA and European Commission– this slideshare presents a Solution Provider’s perspective on the impact of Master Data on the UDI submission to the FDA UDI data base. In detail, the presentation highlights the following subjects:
- A checklist for compliance – What to consider when selecting a solution for UDI data submission
- Data management as a lever for streamlined submissions – Current situation, challenges, and best practices for establishing data governance within an organization
- How PTC solutions support UDI and data governance – PTC’s UDI solution and the broader approach for central product data management
If you are selling medical devices in the US, your devices are subject to new regulatory requirements under the FDA Unique Device Identification (UDI) rule.
UL experts have been actively working with customers with gap assessments, project planning and more to support compliance with these requirements. In this webinar, Ms. Linda Chatwin, RAC will be sharing some of our key learnings.
UL offers a full suite of services to support compliance with FDA's UDI Rule.
For more information, please contact us and request a sell sheet at Medical.Inquiry@ul.com, visit our UDI webpage or speak directly with one of our experts at 1-877-854-3577 or +91 804 138 4434
http://industries.ul.com/blog/us-fda-unique-device-identification-udi-implementation-deadline-in-place-for-medical-devices
UDI: What & How within the overall Medical Device value chainnancykathlen
Free Webinar on Unique Device Identification (UDI): What & How within overall Medical Device Value Chain June 18th 2015. This webinar provides insights into various aspects of UDI, discuss the operational aspects of implementing and integrating UDI within the overall Medical Device value chain.
Leveraging UDI Database Requirements to Drive Data GovernancePTC
Delivered at the event “UDIs and Traceability for Medical Devices 2014” in Munich, May 21 – 22, 2014, Europe's only UDI-dedicated event for the medical device industry – with keynotes from the FDA and European Commission– this slideshare presents a Solution Provider’s perspective on the impact of Master Data on the UDI submission to the FDA UDI data base. In detail, the presentation highlights the following subjects:
- A checklist for compliance – What to consider when selecting a solution for UDI data submission
- Data management as a lever for streamlined submissions – Current situation, challenges, and best practices for establishing data governance within an organization
- How PTC solutions support UDI and data governance – PTC’s UDI solution and the broader approach for central product data management
If you are selling medical devices in the US, your devices are subject to new regulatory requirements under the FDA Unique Device Identification (UDI) rule.
UL experts have been actively working with customers with gap assessments, project planning and more to support compliance with these requirements. In this webinar, Ms. Linda Chatwin, RAC will be sharing some of our key learnings.
UL offers a full suite of services to support compliance with FDA's UDI Rule.
For more information, please contact us and request a sell sheet at Medical.Inquiry@ul.com, visit our UDI webpage or speak directly with one of our experts at 1-877-854-3577 or +91 804 138 4434
http://industries.ul.com/blog/us-fda-unique-device-identification-udi-implementation-deadline-in-place-for-medical-devices
UDI: What & How within the overall Medical Device value chainnancykathlen
Free Webinar on Unique Device Identification (UDI): What & How within overall Medical Device Value Chain June 18th 2015. This webinar provides insights into various aspects of UDI, discuss the operational aspects of implementing and integrating UDI within the overall Medical Device value chain.
Ergonomische Gestaltung von Arbeitssystemen für den LayoutplanerAndré Jordan
Vortrag auf dem Erfahrungsaustausch des REFA/VDG-Fachausschuss-Giesserei. Er wurde von meinem Kollegen Fritz Brandt gehalten (http://www.ergo-consult-magdeburg.de).
FREYR UDI VISION SERIES SESSION 1 - UDI READINESSFreyr Solutions
Very few device manufacturers have experienced the impact and challenges faced during UDI compliance. A very crucial aspect being aware and assessing the level of UDI readiness, implementation of appropriate standards, feasible technologies and ultimately achieving UDI compliance is a major task.
Unique Device Identification or UDI is a forever project. What's the best way for orthopaedic device companies to receive return on their investment? What best practices can be learned for a continually-smooth process? How can the data be leveraged to enhance your company’s value proposition? The true value of UDI is not in the identification number, but in the data that can be generated as a result of UDI. This session will provide attendees with an outline of the opportunities that manufacturers can leverage beyond implementation.
Implementing a Global Unique Device Identification (UDI) Solution: Regional U...Greenlight Guru
UDI data requirement experts Gary Saner and John Lorenc of Reed Tech will discuss best practices for UDI preparations and the future potential impacts to medical device manufacturers as global health authorities publish mandates.
This session will give suggested best practices concerning EU EUDAMED preparation, what we have learned via testing and a Q&A session. Bring your specific questions concerning medical device registration scenarios, data elements and requirements. The speakers will review and provide clarity on currently posted guidance and answer your questions concerning EUDAMED and other health authority timelines.
This presentation originally aired during the 2021 State of Medical Device Virtual Summit.
Unique Device Identification: Manufacturer, Hospital and Global ImplicationsApril Bright
Unique device identification (UDI) is gaining global adoption. Now is the time for companies to take a step back and ask: Is my UDI framework scaleable? UDI experts answered questions on the U.S. regulation and provided perspective on ways that device manufacturers can implement a working system—including data management—that can scale with product development and UDI compliance needs. Attendees gained an understanding of new global regulations and practical, implementable advice for compliance.
As UDI deadlines roll out, OEMs are left with many questions on implementation and compliance, including:
How does FDA recommend we direct mark screws and small implants?
How should we proceed as we await the guidance on the Convenience Kit exemption?
What are best practices for entering submissions to GUDID?
How is FDA enforcing UDI?
FDA officials will speak on UDI adoption and UDI data quality. Bring your questions. Ample time will be saved for Q&A.
OIMP Minotaur Software Barcode and Traceability Workshop judithkirkness
This slideshow is from a workshop about traceability and barcode decoding. It outlines the benefits of having an end to end traceability system, how to use traceability to gain a competitive advantage and how to decode GS1-128 Barcodes.
As per FDAs UDI final ruling, GUDID will accept only DI information and it is the responsibility of the medical device manufacturer to maintain the PI information for any future regulatory and quality audits
On September 24, 2013, the U.S. Food and Drug Administration announced the new requirement to identify medical devices that affect its safe and effective use through the use of UDI. Explore on how Freyr can help medical device companies achieve UDI compliance.
Ergonomische Gestaltung von Arbeitssystemen für den LayoutplanerAndré Jordan
Vortrag auf dem Erfahrungsaustausch des REFA/VDG-Fachausschuss-Giesserei. Er wurde von meinem Kollegen Fritz Brandt gehalten (http://www.ergo-consult-magdeburg.de).
FREYR UDI VISION SERIES SESSION 1 - UDI READINESSFreyr Solutions
Very few device manufacturers have experienced the impact and challenges faced during UDI compliance. A very crucial aspect being aware and assessing the level of UDI readiness, implementation of appropriate standards, feasible technologies and ultimately achieving UDI compliance is a major task.
Unique Device Identification or UDI is a forever project. What's the best way for orthopaedic device companies to receive return on their investment? What best practices can be learned for a continually-smooth process? How can the data be leveraged to enhance your company’s value proposition? The true value of UDI is not in the identification number, but in the data that can be generated as a result of UDI. This session will provide attendees with an outline of the opportunities that manufacturers can leverage beyond implementation.
Implementing a Global Unique Device Identification (UDI) Solution: Regional U...Greenlight Guru
UDI data requirement experts Gary Saner and John Lorenc of Reed Tech will discuss best practices for UDI preparations and the future potential impacts to medical device manufacturers as global health authorities publish mandates.
This session will give suggested best practices concerning EU EUDAMED preparation, what we have learned via testing and a Q&A session. Bring your specific questions concerning medical device registration scenarios, data elements and requirements. The speakers will review and provide clarity on currently posted guidance and answer your questions concerning EUDAMED and other health authority timelines.
This presentation originally aired during the 2021 State of Medical Device Virtual Summit.
Unique Device Identification: Manufacturer, Hospital and Global ImplicationsApril Bright
Unique device identification (UDI) is gaining global adoption. Now is the time for companies to take a step back and ask: Is my UDI framework scaleable? UDI experts answered questions on the U.S. regulation and provided perspective on ways that device manufacturers can implement a working system—including data management—that can scale with product development and UDI compliance needs. Attendees gained an understanding of new global regulations and practical, implementable advice for compliance.
As UDI deadlines roll out, OEMs are left with many questions on implementation and compliance, including:
How does FDA recommend we direct mark screws and small implants?
How should we proceed as we await the guidance on the Convenience Kit exemption?
What are best practices for entering submissions to GUDID?
How is FDA enforcing UDI?
FDA officials will speak on UDI adoption and UDI data quality. Bring your questions. Ample time will be saved for Q&A.
OIMP Minotaur Software Barcode and Traceability Workshop judithkirkness
This slideshow is from a workshop about traceability and barcode decoding. It outlines the benefits of having an end to end traceability system, how to use traceability to gain a competitive advantage and how to decode GS1-128 Barcodes.
As per FDAs UDI final ruling, GUDID will accept only DI information and it is the responsibility of the medical device manufacturer to maintain the PI information for any future regulatory and quality audits
On September 24, 2013, the U.S. Food and Drug Administration announced the new requirement to identify medical devices that affect its safe and effective use through the use of UDI. Explore on how Freyr can help medical device companies achieve UDI compliance.
Barcode & RFID Convergence: Enabling Greater Visibility Through StandardsVDC Research Group
This webcast was presented by VDC Research on the convergence of Barcode and RFID technologies on the GS1 US Visibility Framework.
Barcode is the dominant track and trace technology on the planet today and its value proposition is being extended by the more automated features of RFID. While these two technologies are often viewed as competitive, they are actually complimentary, and organizations are realizing the best of both worlds when they use GS1 standards as the framework for integrating RFID to improve their business processes.
Members of GS1 US and/or EPCglobal US will see that they not only have the foundation for enhanced visibility solutions, but they can implement them in a more cost effective and timely manner - all while realizing the benefits of building those solutions on a common architecture.
This webinar is focused on the current state of UDI regulations, the best approaches to medical device UDI Compliance in the cloud and how to gain business benefits by implementing KPIT's UDI Cloud Solution. This is a must-watch session for medical device companies who are preparing for UDI compliance or the ones who have already implemented however looking for a long-term solution.
PTC Successfully Submits Test Data to the FDA’s Global Unique Device Identifi...PTC
PTC (Nasdaq: PTC) announces it has successfully submitted UDI data to the preproduction version of the US Food and Drug Administration’s Global Unique Device Identifier Database (GUDID) through the Electronic Submission Gateway (ESG) in the required HL7 SPL format. The FDA’s UDI rule aims to dramatically reduce the instances of patient injury and death that result from the misidentification of medical devices.
Smart Labels - Digital Innovation by Raw Material Suppliers to Support Drug M...MilliporeSigma
This webinar will highlight different barcode types, regulations and standards applied to 2D barcodes in the industry, as well as applications and advantages of 2D Data Matrix barcodes.
Digital technologies offer new opportunities to provide and exchange information between raw material suppliers and their customers. While accessing product-related data for different raw materials and devices is essential, it can be a cumbersome task in the pharmaceutical quality and production processes. Often, data processing is required at many steps and must be done manually, which is time consuming and a source for potential errors. 2D Data Matrix barcodes offer a seamless and robust solution for data management, internal processes and inventory management challenges.
In this webinar, you will learn:
• Overview of different barcode types
• Regulations and standards applied to 2D barcodes in the industry
• Applications and advantages of 2D Data Matrix barcodes
Smart Labels - Digital Innovation by Raw Material Suppliers to Support Drug M...Merck Life Sciences
This webinar will highlight different barcode types, regulations and standards applied to 2D barcodes in the industry, as well as applications and advantages of 2D Data Matrix barcodes.
Digital technologies offer new opportunities to provide and exchange information between raw material suppliers and their customers. While accessing product-related data for different raw materials and devices is essential, it can be a cumbersome task in the pharmaceutical quality and production processes. Often, data processing is required at many steps and must be done manually, which is time consuming and a source for potential errors. 2D Data Matrix barcodes offer a seamless and robust solution for data management, internal processes and inventory management challenges.
In this webinar, you will learn:
• Overview of different barcode types
• Regulations and standards applied to 2D barcodes in the industry
• Applications and advantages of 2D Data Matrix barcodes
This presentation will provide a comprehensive knowledge on current UDI labeling standards and how medical device companies can implement the best practices to assure compliance.
Similar to GS1: Conformance Barcoding in Manufacturing (20)
Providing innovative technology solutions across the
healthcare environment, VisionID empower healthcare
professionals to enhance patient safety and care
Essentials of Automations: Optimizing FME Workflows with ParametersSafe Software
Are you looking to streamline your workflows and boost your projects’ efficiency? Do you find yourself searching for ways to add flexibility and control over your FME workflows? If so, you’re in the right place.
Join us for an insightful dive into the world of FME parameters, a critical element in optimizing workflow efficiency. This webinar marks the beginning of our three-part “Essentials of Automation” series. This first webinar is designed to equip you with the knowledge and skills to utilize parameters effectively: enhancing the flexibility, maintainability, and user control of your FME projects.
Here’s what you’ll gain:
- Essentials of FME Parameters: Understand the pivotal role of parameters, including Reader/Writer, Transformer, User, and FME Flow categories. Discover how they are the key to unlocking automation and optimization within your workflows.
- Practical Applications in FME Form: Delve into key user parameter types including choice, connections, and file URLs. Allow users to control how a workflow runs, making your workflows more reusable. Learn to import values and deliver the best user experience for your workflows while enhancing accuracy.
- Optimization Strategies in FME Flow: Explore the creation and strategic deployment of parameters in FME Flow, including the use of deployment and geometry parameters, to maximize workflow efficiency.
- Pro Tips for Success: Gain insights on parameterizing connections and leveraging new features like Conditional Visibility for clarity and simplicity.
We’ll wrap up with a glimpse into future webinars, followed by a Q&A session to address your specific questions surrounding this topic.
Don’t miss this opportunity to elevate your FME expertise and drive your projects to new heights of efficiency.
LF Energy Webinar: Electrical Grid Modelling and Simulation Through PowSyBl -...DanBrown980551
Do you want to learn how to model and simulate an electrical network from scratch in under an hour?
Then welcome to this PowSyBl workshop, hosted by Rte, the French Transmission System Operator (TSO)!
During the webinar, you will discover the PowSyBl ecosystem as well as handle and study an electrical network through an interactive Python notebook.
PowSyBl is an open source project hosted by LF Energy, which offers a comprehensive set of features for electrical grid modelling and simulation. Among other advanced features, PowSyBl provides:
- A fully editable and extendable library for grid component modelling;
- Visualization tools to display your network;
- Grid simulation tools, such as power flows, security analyses (with or without remedial actions) and sensitivity analyses;
The framework is mostly written in Java, with a Python binding so that Python developers can access PowSyBl functionalities as well.
What you will learn during the webinar:
- For beginners: discover PowSyBl's functionalities through a quick general presentation and the notebook, without needing any expert coding skills;
- For advanced developers: master the skills to efficiently apply PowSyBl functionalities to your real-world scenarios.
DevOps and Testing slides at DASA ConnectKari Kakkonen
My and Rik Marselis slides at 30.5.2024 DASA Connect conference. We discuss about what is testing, then what is agile testing and finally what is Testing in DevOps. Finally we had lovely workshop with the participants trying to find out different ways to think about quality and testing in different parts of the DevOps infinity loop.
GDG Cloud Southlake #33: Boule & Rebala: Effective AppSec in SDLC using Deplo...James Anderson
Effective Application Security in Software Delivery lifecycle using Deployment Firewall and DBOM
The modern software delivery process (or the CI/CD process) includes many tools, distributed teams, open-source code, and cloud platforms. Constant focus on speed to release software to market, along with the traditional slow and manual security checks has caused gaps in continuous security as an important piece in the software supply chain. Today organizations feel more susceptible to external and internal cyber threats due to the vast attack surface in their applications supply chain and the lack of end-to-end governance and risk management.
The software team must secure its software delivery process to avoid vulnerability and security breaches. This needs to be achieved with existing tool chains and without extensive rework of the delivery processes. This talk will present strategies and techniques for providing visibility into the true risk of the existing vulnerabilities, preventing the introduction of security issues in the software, resolving vulnerabilities in production environments quickly, and capturing the deployment bill of materials (DBOM).
Speakers:
Bob Boule
Robert Boule is a technology enthusiast with PASSION for technology and making things work along with a knack for helping others understand how things work. He comes with around 20 years of solution engineering experience in application security, software continuous delivery, and SaaS platforms. He is known for his dynamic presentations in CI/CD and application security integrated in software delivery lifecycle.
Gopinath Rebala
Gopinath Rebala is the CTO of OpsMx, where he has overall responsibility for the machine learning and data processing architectures for Secure Software Delivery. Gopi also has a strong connection with our customers, leading design and architecture for strategic implementations. Gopi is a frequent speaker and well-known leader in continuous delivery and integrating security into software delivery.
UiPath Test Automation using UiPath Test Suite series, part 4DianaGray10
Welcome to UiPath Test Automation using UiPath Test Suite series part 4. In this session, we will cover Test Manager overview along with SAP heatmap.
The UiPath Test Manager overview with SAP heatmap webinar offers a concise yet comprehensive exploration of the role of a Test Manager within SAP environments, coupled with the utilization of heatmaps for effective testing strategies.
Participants will gain insights into the responsibilities, challenges, and best practices associated with test management in SAP projects. Additionally, the webinar delves into the significance of heatmaps as a visual aid for identifying testing priorities, areas of risk, and resource allocation within SAP landscapes. Through this session, attendees can expect to enhance their understanding of test management principles while learning practical approaches to optimize testing processes in SAP environments using heatmap visualization techniques
What will you get from this session?
1. Insights into SAP testing best practices
2. Heatmap utilization for testing
3. Optimization of testing processes
4. Demo
Topics covered:
Execution from the test manager
Orchestrator execution result
Defect reporting
SAP heatmap example with demo
Speaker:
Deepak Rai, Automation Practice Lead, Boundaryless Group and UiPath MVP
PHP Frameworks: I want to break free (IPC Berlin 2024)Ralf Eggert
In this presentation, we examine the challenges and limitations of relying too heavily on PHP frameworks in web development. We discuss the history of PHP and its frameworks to understand how this dependence has evolved. The focus will be on providing concrete tips and strategies to reduce reliance on these frameworks, based on real-world examples and practical considerations. The goal is to equip developers with the skills and knowledge to create more flexible and future-proof web applications. We'll explore the importance of maintaining autonomy in a rapidly changing tech landscape and how to make informed decisions in PHP development.
This talk is aimed at encouraging a more independent approach to using PHP frameworks, moving towards a more flexible and future-proof approach to PHP development.
Elevating Tactical DDD Patterns Through Object CalisthenicsDorra BARTAGUIZ
After immersing yourself in the blue book and its red counterpart, attending DDD-focused conferences, and applying tactical patterns, you're left with a crucial question: How do I ensure my design is effective? Tactical patterns within Domain-Driven Design (DDD) serve as guiding principles for creating clear and manageable domain models. However, achieving success with these patterns requires additional guidance. Interestingly, we've observed that a set of constraints initially designed for training purposes remarkably aligns with effective pattern implementation, offering a more ‘mechanical’ approach. Let's explore together how Object Calisthenics can elevate the design of your tactical DDD patterns, offering concrete help for those venturing into DDD for the first time!
UiPath Test Automation using UiPath Test Suite series, part 3DianaGray10
Welcome to UiPath Test Automation using UiPath Test Suite series part 3. In this session, we will cover desktop automation along with UI automation.
Topics covered:
UI automation Introduction,
UI automation Sample
Desktop automation flow
Pradeep Chinnala, Senior Consultant Automation Developer @WonderBotz and UiPath MVP
Deepak Rai, Automation Practice Lead, Boundaryless Group and UiPath MVP
Transcript: Selling digital books in 2024: Insights from industry leaders - T...BookNet Canada
The publishing industry has been selling digital audiobooks and ebooks for over a decade and has found its groove. What’s changed? What has stayed the same? Where do we go from here? Join a group of leading sales peers from across the industry for a conversation about the lessons learned since the popularization of digital books, best practices, digital book supply chain management, and more.
Link to video recording: https://bnctechforum.ca/sessions/selling-digital-books-in-2024-insights-from-industry-leaders/
Presented by BookNet Canada on May 28, 2024, with support from the Department of Canadian Heritage.
Accelerate your Kubernetes clusters with Varnish CachingThijs Feryn
A presentation about the usage and availability of Varnish on Kubernetes. This talk explores the capabilities of Varnish caching and shows how to use the Varnish Helm chart to deploy it to Kubernetes.
This presentation was delivered at K8SUG Singapore. See https://feryn.eu/presentations/accelerate-your-kubernetes-clusters-with-varnish-caching-k8sug-singapore-28-2024 for more details.
SAP Sapphire 2024 - ASUG301 building better apps with SAP Fiori.pdfPeter Spielvogel
Building better applications for business users with SAP Fiori.
• What is SAP Fiori and why it matters to you
• How a better user experience drives measurable business benefits
• How to get started with SAP Fiori today
• How SAP Fiori elements accelerates application development
• How SAP Build Code includes SAP Fiori tools and other generative artificial intelligence capabilities
• How SAP Fiori paves the way for using AI in SAP apps
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
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
11. What is required?
Barcode
Software
The GS1
General
Specifications
(Version 13)
A Printer
Regulatory
Documents
Other
documents,
Helpdesk,
Technical
Guide etc.
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
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
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
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
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
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