GS1 Connect – Bridging the Gap

Join Jeff Denton (AmerisourceBergen) and Gary Lerner (Gateway Checker) as they discuss how to bridge the gap to US Drug traceability at the GS1 Connect Digital Conference, June 16 and 17.

GS1 Connect: Bridging the Gap to Pharmaceutical Traceability

FDA regulations mandates interoperable, electronic tracing of medicines at the item level to enhance the security of the US Drug supply chain by 2023.

Establishing traceability requires accurate and complete data sharing among trading partner within the drug supply network.

Closing the gap to traceability is essential for major US pharmaceutical wholesalers. See the challenges AmerisourceBergen faces as they prepare to onboard more than 500 drug manufacturers and accept serialized electronic transactions from nearly 25,000 drugs   Learn how they utilize new tools and technology from Gateway Checker to test, evaluate and certify conformance to GS1 US traceability standards.

Conformance to the GS1 Electronic Product Code Information Services (EPCIS) standards specific to the Drug Supply Chain Security Act allows trading partners within the supply chain to enable compatible connections: first-time, every-time.

Register for complimentary attendance to the GS1 Connect Digital conference.

Gateway Checker’s Gary Lerner to Discuss Pharmaceutical Traceability at GS1 Connect

Gary Lerner, president and founder of Gateway Checker and expert on supply chain integrity, will be discussing the future of pharmaceutical traceability at the GS1 Connect virtual conference, taking place June 16-17, 2020. Gary, together with Jeff Denton of AmerisourceBergen, will present “Bridging the Gap to Pharmaceutical Traceability” as an On Demand session, which will be available throughout the two-day event.

During their session, Gary and Jeff will explore how the drug industry as a whole is adjusting to the requirements outlined in the Drug Supply Security Act of 2013 and what companies can do today to prepare for the new traceability standards that will be required by 2023. These requirements aim to help the FDA understand what product is in the supply chain, where it has been, where it is going, and who is handling it; and to ensure that only legitimate, safe products end up on the market.

Currently, much of the data collected along the drug supply chain is either inadequate or not interoperable according to accepted industry guidelines. Many organizations have developed their own proprietary solutions or workarounds that don’t play well together. Gary will address how agreeing upon and employing a “common language” across the pharmaceutical industry is vital in preparing for the upcoming regulations and requirements.

FREE Registration for GS1 Connect is open through Friday, June 12 at

About Gateway Checker

Gateway Checker provides software to help the pharmaceutical industry quickly, accurately and thoroughly ensure data accuracy and integrity about the products moving through the drug supply chain. Gateway Checker is a GS1 Certified Conformance Testing Service, and can attest to full conformance with the GS1 US Rx EPCIS traceability requirements.

About GS1 Connect

GS1 Connect is an annual event hosted by GS1 US for the purpose of bringing trading partners together to network and learn about the value of using standards-based business processes and best practices for optimum efficiencies in managing the supply and demand sides of their value chain. Due to COVID-19, this year’s event will be virtual.

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Why Supply Chain Integrity Matters

Why It Matters

Our Lives Depend On Integrity.

We trust that planes will fly, bridges and buildings will support us, and our cars will stop when we brake. When we ingest food and medicine, we trust they will do no harm. We know red means stop and green means go. In an intersection, we trust only one path has the green light. Without a second thought, we trust many of the products and services we use. Though we rarely think about it, our lives depend on the design, manufacturing, and integrity of the supply chain. Without integrity in these things, there are accidents, sickness, disease, and death.

How Did We Get This Way?

A product or service becomes trustworthy because it performs according to our expectation. It doesn’t happen on its own. When we trust a product or service to deliver its expected value, implicitly we are trusting the design, construction, testing, and delivery process as well as the people behind them.

Principals are devised. Regulations are promulgated. Standards are established. Products are made. Compliance is tested. We trust our engineers, our institutions, and our markets to design and deliver safe and healthy products and services.

Our government sets the standard for acceptance and creates and enforces regulations when lack of integrity harms society. All along the way, it is the integrity of the people, institutions, and the process that allows us to trust and expect that our lives are better served.

Standards Are At The Heart Of Integrity

The application of standards enables the checking and verification of integrity. We communicate what needs to be designed, built, and tested based on adherence to standards.

Imagine a world where standards lack integrity:

  • Does a red light mean you will absolutely stop? Or is it a recommendation that you should consider stopping?
  • Are our medicines safe, sterile, and effective?
  • Can we eat our food without fear of sickness, disease, or death?

Without standards that are clear, verifiable, and enforceable, we are left to wonder about integrity.

Traceability Enables Supply Integrity

We believe that traceability from ingredient to ingestion is essential for the safety and security of our life sustaining supply chains such as foods, medical devices, and medicines. To attain supply integrity, we must ensure only legitimate, uniquely identified products move through the supply chain and are handled by trusted, licensed, and authorized trading partners.

We know from more than 15 years of experience that attaining traceability requires connectivity and information interoperability. Item serialization and tracking are challenging, and they are disrupting established methods of packaging and order fulfillment. But implementing a standardized serialization system is critical to maintaining supply chain integrity.

Integrity – Standards – Traceability

We need integrity in our people, products, services, and technology to enable safe, secure, and sustainable lives. Attaining integrity requires trust. Trust comes from products and services that perform to standards. Traceability provides transparency that enables trust, and at the same time the opportunity for verification.

About Gateway Checker, LLC

Gateway Checker™ is a Software as a Service offering established to unambiguously assess and verify the readiness of one system to connect and exchange electronic product code information with another. Gateway Checker tests, evaluates, and certifies connectivity between different organizations with the objective of seamless interoperability. Gateway Checker is certified by the GS1 US RX EPCIS Testing Service Certification Program and is owned and operated by the Gateway Checker Corporation, a wholly owned subsidiary of BrandSure, LLC.

Over the coming months, we will share our experiences and lessons learned. Sign up for our newsletter to receive the latest updates from Gateway Checker. We are interested in hearing the challenges you and your company are facing in today’s climate. Get in touch with us and let us help you address these challenges.

GS1 Connect 2020 Digital Edition

We will be presenting at this year’s GS1 Connect Conference.

GS1 US has created a digital conference experience that brings you the best of both worlds: highly curated program content and the flexibility for when and where you choose to engage. Join on June 16-17, 2020 to hear why the role of supply chain and unique identification have never been more important. Learn about trends from industry leaders and keynote speakers. Get up to speed on ways GS1 Standards are helping organizations adapt and accelerate to re-invent their supply chains to match shifting customer experiences. Participate in cross-industry and track sessions for Retail, Grocery, Foodservice, Healthcare, Tech, and Innovation. Explore emerging technologies with the Startup Lab Pitch Competition to be better prepared for the future of commerce. There will be no charge to attend allowing for more of our community to participate. Stay tuned as we share additional agenda details in the coming weeks.

Date: 16-17 June 2020
Location: Denver, CO, United States