*NOTE – We are including a Free Trading Partner Integration template for you to download at the end of this article.
The 2023 DSCSA requirement looms in the near future and pharma companies are frantically working together to create and implement the technological goals that create the interoperable system by November 27, 2023. To achieve the three areas of interoperability as defined by the PDSA—exchange, verification, and tracing—these companies must also land on a common informational framework.
In other words, to create a system that allows for the DSCSA vision of “fully interoperable, electronic tracing of products at the package level,” the industry needs to pick a common standard and use it throughout pharma. I discuss the challenges in my previous article: Drug Supply Chain Security Act, Phase II: Here’s what you MUST know.
Gary Lerner, the president at Gateway Checker Corporation, explained what it would take to make this happen. In short: “Capturing and exchanging information at this level of specificity requires a common information framework.”
The system he favors? And what the industry favors:
EPCIS, or the Electronic Product Code Information Service.
EPCIS is a conformance testing service that is being implemented to streamline communication and cut down on back-and-forth between Pharma manufacturers and trading partners. While the ultimate goal is to get the ball rolling on efficient data exchange, EPCIS has some data exchange issues of its own.
In this post, we will first look at the origin and functionality of EPCIS and then evaluate these issues.
EPCIS: What Is It?
A global GS1 Standard for creating and sharing visibility of event data. Users can gain a shared view of a physical or digital objects from a business context. “Objects” are the physical objects that are handled in physical steps of an overall business process. These physical objects can be most anything, like medicine, and food products. EPCIS was conceived on a part of a broader effort to enhance collaboration between trading partners. The standard applies to any situations in which event data is to be captures and shared.
Consider how difficult communication would be with eight people in one room and they each spoke a different language. In many ways, the push to the DSCSA requirements is creating similar problems for the industry as both manufacturers and downstream trading partners struggle to figure out the best way to exchange information on products despite a current “language barrier” in their unique tracking systems.
You can break down the EPCIS standard into these specific parts:
Data Definition Layer which defines a standard model for visibility of events. A Services Layer that defines two standard interface.
- EPCIS Capture Interface – EPCIS data can be delivered by interacting with a capturing application interacting through scanning bar codes or reading RFID tags.
- EPCIS Query Interface – Trading partners may obtain EPCIS data typically interacting with an EPCIS repository.
EPCIS Data Model
A collection of EPCIS events that provide a detailed picture of a business process. The data in a single EPCIS event is made up of four dimensions.
What – The identifier of the object(s) or subject of an event.
When – Date and time of when the event happened.
Where – The identifier of the location of where the event happened.
Why – Info on the context of the business. example, shipping, receiving, picking, etc.
GSI is a non-profit organization that has offered a potential method of changing this. GS1’s work is in the field of business communications—typically designing and maintaining global standards for business communication—and GS1 introduced the EPCIS standard as a method to improve visibility and traceability in any supply chain.
For a better explanation of EPCIS, we can turn to GS1, which states, “EPCIS is a GS1 standard that enables trading partners to share information about the physical movement and status of products as they travel throughout the supply chain – from business to business and ultimately to consumers. It helps answer the ‘what, where, when and why’ questions to meet consumer and regulatory demands for accurate and detailed product information.”
Even more importantly, the GS1 goes on to explain that the system, by intent, is aimed at being a catalyst of interoperability, saying, “EPCIS is intended to be used in conjunction with the GS1 Core Business Vocabulary standard. The CBV provides definitions of data values that may be used to populate the data structures defined in the EPCIS standard. The use of the standardized vocabulary provided by the CBV standard is critical to interoperability and critical to provide for querying of data by reducing the variation in how different businesses express common intent.”
How Does the EPCIS Standard Function
When GS1 created the EPCIS standard, the focus was not specifically the pharma industry. This makes sense, however, because of its broad application: the standard is used as a way of linking different applications to help multiple companies share event data. In effect, this leads to the following when used in the supply chain:
End-to-end visibility: increased visibility stems from the system’s allowance of different applications to communicate with one another. Information silos are broken down and the information flows freely, allowing for end-to-end as a product moves through the chain.
Monitoring and Preventing Errors: Issues can be identified and corrected early on in a supply chain following the destruction of information silos. Also, it is possible to establish an alerting system that will raise a red flag if something goes wrong within the process, and the result of this is constant monitoring for and prevention of errors.
More analysis of the data in the supply chain: Finally, since the data from the entire chain is within grasp, more can be learned from it analytically, such as the location of possible process roadblocks or which trading partner is lagging behind the others.
In addition to these three end results, the EPCIS also works like a good news reporter, answering the who, what, where, when, and why of supply chain event. The questions of who is involved, what happened, where did it happen, when did it happen, and why did it happen give everything needed for bringing context to a real-world transaction within the supply chain.
Real World Scenario
Everything i wrote is all fine, but i am sure you are scratching your head wondering how does EPCIS apply to the real-world? As I mentioned earlier, EPCIS does not only apply to Pharma.
Let’s apply this to something more sensible. Here are a few standard EPCIS events.
Commission, Aggregation, Disaggregation, Observation, Transformation, and Decommission. These are related to the What, When, Where and Why. If we look at the Pork value chain provided by Byteally:
You can see how you can apply EPCIS events to your process. This can be subjected to any industry. To Design a process using EPCIS start with these five visibility goals:
- Define your goals and requirements.
- Document business process flows.
- Break each process flow into a series of steps.
- Decide which steps require visibility events.
- Decide which data to include in the visibility events.
Here is an illustration of creating a process defining your visibility events:
Illustration provided by GS1
EPCIS Isn’t Perfect
The EPCIS is the best current answer for the pharma industry as it grapples with preparing for Phase II of DSCSA, but that does not mean the system is without flaw. As mentioned, one such problem EPCIS presents is the fact that it was not made specifically for one industry, so any industry that uses it needs to help implement it through the specialization of its service.
Lerner, at the GS1 Connect: Digital Edition virtual conference explained why EPCIS might be the best answer but still present challenges, saying, “EPCIS is a general purpose exchange standard. Application-specific standards are therefore necessary to tailor EPCIS to suit a specific industry and application.”
He also provided examples of how EPCIS is being tailored for pharma: “In 2015, the GS1 US Healthcare working group recruited more than 50 companies representing a cross-section of the pharmaceutical industry to adapt EPCIS to address DSCSA specific requirements. And in 2016, the application standards governing DSCSA traceability were published. Adopting these standards therefore helps different businesses within the drug supply chain to more efficiently and effectively connect and share information.”
On top of the issues of simply having to modify the system to work with the pharma industry, other issues are cropping up as well.
AmerisourceBergen Corporation (ABC) is currently testing the system, and the company has pinpointed several issues with the EPCIS files coming from drug manufacturers. Jeff Denton, vice president, global secure supply chain at ABC, recently reported that he’d received somewhere between 30 and 40 files and “nearly every single one of them had issues upfront with their initial testing. I don’t think I had a single file come in for the first time that was accurate.”
While this certainly does not sound promising, Denton and his team are working vigorously to test the process so the errors can be identified and ultimately corrected.
Of the errors, three common issues seem to have arisen, and he broke those down for Healthcare Packaging, which we will review below.
Issues With EPCIS Data Exchange
As shared by Denton, the most common issues he has seen with the EPCIS system stem from either the absence or delay of information. The issues fit into the following categories:
Event time is missing: In EPCIS standards, the event time is a point when any event takes place. This could be commissioning a bottle on the packaging line or packing it into a case or shipping it. More details on these events can be found in the earlier section, “How does the EPCIS Standard Function?”
For the process to work correctly, every single event needs to come in sequential ordering because when the data arrives at the trading partner, “The very first thing their system is looking for is making sure it is all in sequence, and they use that event time as a process to do that,” according to Denton.
Unfortunately, it does not always work out like this, as the system occasionally misses tracking some events. One example was a file that was nearly complete, save for a few missing dates in association with events. Other examples all have the same loose problem: lack of consistency in the event time, date, or other information.
No children: Denton said that the absence of child records in a file has been yet another problem. In this situation, he and his team receive the serial number for the case, but not the actual contents.
As he explained, “This is not [a product] that would be going through downstream distribution at a case level. That would be understandable. This is something that is shipped typically at the unit level.”
Unless EPCIS can be further adapted to track cases with children, the industry will be at risk to see lots of returns.
When there is a missing piece of information regarding either the event or the children, there is also repercussion downstream. Typically this manifests as a stall in the process for getting the product shipped to customers downstream.
In short, every issue in the early analysis with EPCIS triggers more issues along the road, including testing delays.
Denton said these delays can go on for a long time. “Once an issue is identified by a system when we’re going through the test phase with a trading partner, all the processing of that file stops. So we go back and forth with manufacturers and in some cases, we’ve had to do that for three months.”
Ultimately, that can back up the entire chain.
Integrating with your Trading Partners
To help facilitate communication of your master data with your Trading partners. TrackTraceRx is providing an excel template that will help exchange all of your complex data needed to have a successful integration and communication. You can download the file here:
Working to Resolve the Issues of EPCIS
Early-onset issues with EPCIS can lead to emails, phone calls and possibly even conference calls between the manufacturer and trading partner to make sure both parties understand the reasoning for the error in the file. But there is still hope–once they have identified the origin of the error, the communication process can be reset and retested.
Eventually, the original problem might be ironed out, but that still is not the end of the process testing. After one successful test, the system might find another issue, thus putting a halt to the process once again.
Denton believes there is not enough time between now and 2023 to devote these labor-intensive remediation efforts to every trading partner, but he and his team are doing as much as they can.
At the end of the day, getting the issues in the data exchange ironed out early on will save tons of time and resources moving forward with the implementation. While Denton can only speak to his personal experience with ABC, he said, “we shipped 3 million units outbound every day, and we must make sure that all the data is available to us on the inbound shipment.
So, when we send out nearly 4,000 purchase orders to manufacturers a day, we’re getting back nearly 4,000 shipments every day. Some of them are one case and some of them are multiple tractor-trailer loads for a single purchase order. So, it’s very important that that data for the inbound shipment to us is accurate because if it isn’t, it will impact our ability to receive the product.”
Denton and ABC are by no means the only ones affected by the current issues in EPCIS, and that is why we must hope that the trading partners can put enough time into testing and correcting the data exchange issues between now and 2023 DSCSA Phase II.
While EPCIS has great potential to unlock the door to interoperability, it can also cause many headaches for all stakeholders unless data exchange wrinkles are ironed out – a slow, laborious process.
About the Author: Christian Souza is the Co-Founder of TrackTraceRx