TrackTrace Rx

Month: October 2017

Verification Router Service: How Will It Impact DSCSA Compliance?

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Verification Router Services DSCSALast year the Food and Drug Administration mandated new verification requirements for the drug supply chain, as part of the Drug Supply Chain Security Act (DSCSA). As the DSCSA verification requirements come ever closer, many different methods of handling verification requirements are being analyzed by the pharmaceutical industry.

Methods such as maintaining a central repository that aggregates all relevant data, providing each manufacturer with their own verification database, and having distributors scan outbound products have all been suggested. Not all suggested verification systems suggested are created equal though, and one system stands out as being more workable than the others.

At the end of last year, the Healthcare Distribution Alliance (HDA) completed an analysis of nine potential ways to ensure drug companies meet verification requirements. The HDA then held a workshop where they presented pilot versions of two of the most promising verification systems.

One approach was to have manufacturers aggregate product identifying information and send it to individual distributors, when the distributor needs to process a saleable return they simply reference an internal database to verify the identifier information. The other tactic discussed for was the use of a verification router service (VRS), where a third-party routing service stores all product identifier data locally.

VRS has the potential to make meeting verification requirements easy and convenient, regardless of how many companies it has to serve.

What Is Verification Router Service?

As defined by the HDA, verification router service refers to using a third-party routing system to send product information back and forth between distributors and manufacturers.

“The manufacturer stores all of its product identifier information locally, which is connected to a third-party routing service. Upon receiving a saleable return, the distributor captures the product data and sends the data to this third-party router service, which then routes the query to the appropriate manufacturer’s database,” reads the HDA communication.

How Is Verification Router Service Structured?

HDA’s workshop on VRS did not specify a structure the VRS system would have, but it did provide an example of how a VRS system might operate.

The pilot example shared by the HDA consisted of five different steps, and was anchored by a GTIN-to-IP address table. A manufacturer would have to share their EPCIS repository IP address, as well as their GTINs (Global Trade Item Number), in order for the pilot VRS to function.

HDA’s proposed 5-step process is as follows:

  • Step 1. A wholesale distributor receives a saleable return. They then scan the DSCSA product identifier on either the whole case or the first unit, and acquire the serial number and GTIN for the product.
  • Step 2.  The wholesale distributor sends both the serial number and the GTIN to the VRS. The VRS will then utilize the GTIN to look up the manufacturer’s EPCIS IP address.
  • Step 3. The VRS sends the serial number and GTIN over to the EPCIS for the purposes of verification.
  • Step 4.  The manufacturer’s system responds to the request with the corresponding serial number and GTIN, or with the current status of the units in question.
  • Step 5. The VRS system sends the relevant information to the wholesale distributor who needs it for saleable returns purposes.

This is only one possible way that a VRS system could function. In a webinar from  another organization, an alternate system was proposed, which would see the VRS just providing a wholesale distributor with the EPCIS IP address, which would let them directly communicate with a manufacturer.

This is a less complex method of communication, rather than having the VRS itself communicate with the manufacturer’s EPCIS.

Fewer variables involved in the communication process means better performance, security, and scalability. If the direct communication method were to be used, it is likely that both wholesale distributors and manufacturers would need to employ a web service layer that enables the VRS communications.

What Are the Challenges of Verification Router Service? 

At the HDA workshop three major challenges were identified that must be overcome by a router service.

The first issue is that collaborating and communicating on a task is difficult in an environment that has many different organizations. There are logistical problems that inevitably arise when dealing with large amounts of people, and beyond that different companies in the supply chain will want to have their own frameworks in place that benefit them, meaning negotiation between companies might prove difficult.

The second challenge is that any issues with downtime, outages, or system connectivity issues must be dealt with in a timely and efficient manner. Any delays in the processing of one packet of information will have ripple effects and become amplified due to how interconnected the VRS system is. If a distributor cannot get information from a manufacturer in a timely manner, those who need the information from the distributor will also be inconvenienced.

There are also a variety of problems surrounding the proper scanning, encoding, and formatting of products and product information. It could be difficult to sync scanning equipment with VRS because of the inherent differences in the two forms of technology. A universal format for VRS related product information must also be established.

The pilot program was able to handle a verification request from a distributor to manufacturer in 0.7 seconds. It performed at sub-second speed, meaning that the program is probably able to handle requests in real world operating conditions, despite the fact that in 2019, operators will be required to scan a 2D matrix code before sending their verification request to a router service. This would further complicate the process, and if response times became longer than a second, the return transaction might cut off altogether.

The HDA decision to endorse verification router service as a possible solution to meeting verification requirements has implications for the entire industry. If VRS is successfully implemented, the transfer of verification data between wholesale distributors and manufacturers should be relatively painless and easy. For this to happen though, every company in the supply chain will have to collaborate in the creation of VRS.

Many different companies will be looking at the technology over the coming months and attempting to create their own VRS frameworks.

While settling on a specific framework could prove challenging, at least at the moment, despite all the complexities, VRS seems to present itself as a viable way to meet verification requirements.

About TrackTraceRx Suite

Other solutions on the market today are totally fragmented by only providing one piece of the puzzle. Pharmaceutical companies today are stuck subscribing to multiple services, accessing different companies for support and paying thousands of dollars to integrate different systems. The TrackTraceRx Suite is a game changer by combining the TrackTraceRx Traceability Solution, a ERP, and a Commerce Platform completely integrated out of the box. This eliminates having to deal with multiple support, feature services and integration costs.

Please watch our video at http://www.tracktracesuite.com

About the Author

Chris Souza is the Co-Founder of TrackTraceRx. He loves all things traceability in order to keep products safe! Follow him on Twitter

Chris Souza

How OPEN-SCS’ New Standards Will Impact Packaging Lines and Serial Number Bonding

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Just recently the Open Serialization Communication Standard Group (OPEN-SCS), announced that they will soon introduce their new serialization standard: Packaging Serialization Specification (PSS) 1.0.  OPEN-SCS is an amalgamation of different companies in the healthcare sector who are working together to create a standardized format for packaging line serialization.

The OPEN-SCS’ communication for standardized serialization include recommendations for how to best approach Serial Number Provisioning, Serialization Report Transmission, Unused Serial Number Return, Batch & Master Data Repository.

How Will OPEN-SCS Be Structured?

OPEN-SCS uses a layered approach to implementing serialization standards. The advantage of a layered approach is that it confers more flexibility, reliability, and durability to users and designers, and a layered model can be implemented much faster as well.

The International Society of Automation has laid out a four level model in their ISA-95 guidelines. These four levels can be thought of as levels of organization that go from least to most complex, and should be focused on in all proposed solutions.

  • Level 1 – Devices: includes conveyors, scanners, printers, vision components and scales
  • Level 2 – Line: covers line production at a single production or packaging line at any specific site
  • Level 3 – Site: means a single site at a CMO/CPO or corporation
  • Level 4 – Enterprise: refers to a corporation in its entirety

PSS 1.0 was created through a joint effort by GS1 Global, OPC Foundation, and the ISPE. It covers four use case examples for regular communication between levels 3 and 4 of the serialization process. This new standard will lay the foundation for PSS 2.0 that will provide guidance about nine use cases between Level 2 and Level 3 of the serialization infrastructure. The goal of the new OPEN-SCS standards is to enable smooth communications between layers in a standardized method.

What Does This Mean for Packaging Lines?

This new serialization standard has implications for the entire pharmaceutical industry around the world.  A lack of universally recognized standards for serialization has made communication difficult, even as various serialization deadlines draw ever nearer.

Packaging lines around the world should prepare to switch over to the new standards, as IT equipment and infrastructure must constantly be upgraded. Even if they already have their own serialization equipment, all of these customized models mean that costs are higher. One of the primary objectives of OPEN-SCCS is to make IT connections between systems easy and cheap, but to do this they won’t need to end all the various custom systems around the world.

Open-SCS will effectively let companies and packaging lines with their own solutions hold onto these investments when they acquire sites that utilize a different vendor’s solutions, so long as they have upgraded to the certified OPEN-SCS software. Drug manufacturers will be able to employ a standardized security method for the first time, minimizing the probability of ransomware or malware attacks that can move between systems, even in an environment with systems from different vendors.

Drug manufacturers, contract manufacturers, as well as repackagers should remain vigilant for whenever the OPEN-SCS interface is available as an option they can integrate into their next software updates. The next major updates for L3 and L4 components should come soon, and the updates for L2 and L3 components will happen in the second half of 2018.

Implications for Serial Number Bonding

Serial Number Bonding is a serialization model used by GS1. The way that GS1 categorizes different serialization functions is a problem, as it is often unclear. GS1’s standards often failed to effectively address the needs of those manufacturers who had to rely on implementing their own serialization for their products.

The reason for this is that GS1 breaks down their options into four groups: Identify, Capture, Share and Use. However, they don’t make “bonding” a GS1 identifier to a particular product very easy, which means that Commission events produced by the GS1 model are frequently unreliable. The problems with placing a GS1 identifier onto a particular entity or product mean that the necessary information from the “Use” and “Share” processes, such as supply chain data, that pharmaceutical companies rely on may be incomplete and inadequate.

Standardization is needed to facilitate the easiest possible compliance with the DSCSA and other regulations, but if the standards in question are confusing or hard to follow they won’t achieve their goal of enabling smooth communication and regulatory compliance.

It is hoped that the OPEN-SCS framework will enable GS1 standards to be more easily applied and maintained. Serial numbers and product identifiers relating to GS1 standards will be GS1-conformant, and data will be gathered throughout the process of bonding to ensure corporate databases and EPCIS commission events have all the relevant information. Hopefully the new OPEN-SCS and GS1 standards will mesh easily and assist pharmaceutical companies in placing unique product identifiers on their products, instead of inhibiting them.

About TrackTraceRx Suite

Other solutions on the market today are totally fragmented by only providing one piece of the puzzle. Pharmaceutical companies today are stuck subscribing to multiple services, accessing different companies for support and paying thousands of dollars to integrate different systems. The TrackTraceRx Suite is a game changer by combining the TrackTraceRx Traceability Solution, a ERP, and a Commerce Platform completely integrated out of the box. This eliminates having to deal with multiple support, feature services and integration costs.

Please watch our video at http://www.tracktracesuite.com

About the Author

Chris Souza is the Co-Founder of TrackTraceRx. He loves all things traceability in order to keep products safe! Follow him on Twitter

Chris Souza