Food and Beverages Blog Archives - Page 6 of 6

Not all serialization solutions are created equal. And they’re definitely not a one-size-fits-all proposition. So, if you’re looking for a serialization solution, you’re going to have to take a long, hard look at how your business works, what you’re goals are, and make a lot of decisions about what’s going to work best for you.

Let’s do a quick overview of some of the things to consider while you’re shopping around for a serialization solution for your business.

Data integrity and your serialization solution

Today, it’s all about data. Not surprisingly, then, data integrity must be front and center in your decision-making process.

Most solutions offer compliance and data validation, but few provide continued data validation and verification after implementation. Errors are bound to happen in every supply chain, so we cannot overstate the importance of continued data verification. Product master data has to be accurate and aligned for an efficient, safe, and optimized supply chain. Furthermore, your solution must be able accommodate product changes that might create data inconsistencies among trading partners.

So, make sure your serialization solution provider will work closely with you and catch errors before they get into your system or network. And confirm that they’ll work with all of your trading partners to create a system that meets all data and product standards. Demand a solution that gives you total control, flexibility, trading partner connectivity, and scalability.

Cloudy with a chance of … disruption and inconvenience?

Today, most serialization and traceability software is based in the cloud. But tread carefully: Not all cloud solutions are created equal, either.

Solution providers that offer a multi-tenant architecture often over-simplify what they’re giving you. For example, they’ll say you’ll get automatic software upgrades with little or no effort on your part. However, such uncoordinated updates force you into system upgrades with little or no coordination or consideration for your own system configurations. This can be incredibly disruptive and require revalidation and new system configurations.

Conversely, a single-tenant solution puts control firmly in your hands. You control when to implement updates, meaning you’ll upgrade when it’s convenient for you — not your solution provider — and you’ll ensure your configurations remain intact.

Your solution should grow with you

You want to grow your brand and business, improve your operations, and serve your customers better.

An effective serialization solution will be flexible enough to fit all of your needs while being scalable enough to cover all of your manufacturing and distribution needs. The solution should consider what your systems require now and what they will require in the future as your company grows.

Your solution should also be connected to hundreds of other trading partners, allowing instant communication between network members and transmission of serialization and other crucial, often strictly regulated, data. For example, if you’re a pharmaceutical company operating in the United States, you’ll have to share “T3” information to comply with the Drug Supply Chain Security Act.

Final thoughts

There’s a lot to think about when you’re shopping for a serialization solution. We’ve touched on a few of the key considerations — data integrity, a single-tenant architecture, scalability — but you’ll need to put in the time and effort to reach a conclusion about what’s best for you.

Consider this, though: We will work tirelessly to formulate the solution that best suits your needs. We start with a single-tenant architecture that ensures your solutions are flexible and scalable, giving you complete control over your systems. We provide expert data monitoring to confirm that all of your products are properly serialized and traceable. Our solution uses more than 100 data checks to verify your data and flag errors, giving you the time to fix issues before products ship.

And, importantly, we give you the power to leverage your supply chain for true business value, including brand protection and consumer engagement, no matter what industry you’re in.

Contact us today to learn more about our serialization and traceability solutions. Also take a look around our blog to read about what we do and how we make your supply chain your most valuable business asset.

The DSCSA VRS deadline is one of the most important milestones the pharmaceutical industry needs to meet. The Drug Quality and Security Act (DQSA) was enacted by Congress on November 27, 2013, in doing so amending the Federal Food, Drug, and Cosmetic Act to grant the Food and Drug Administration more authority to regulate and monitor the manufacturing of compounded drugs.

Title II of the bill, the Drug Supply Chain Security Act (DSCSA) is designed to establish requirements to facilitate the tracing of prescription drug products through the pharmaceutical supply distribution chain. It outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed. This will enhance the FDA’s ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful. The system will also improve detection and removal of potentially dangerous drugs from the drug supply chain to protect consumers.

Adopting a phased approach, there are two key deadlines for different stakeholders: November 26^th 2018 is the widely acknowledged deadline for pharmaceutical manufacturers and repackagers; however, given that the FDA has already pushed this deadline back once by a year (from November 2017), the second deadline is unlikely to be met with similar lenience.

On November 27^th 2019, the DSCSA VRS deadline is enacted. The wholesale industries must be compliant and only accept products that contain a serial number or product identifier, and they must verify this product identifier before they can go on to resell these goods. They must also be able to complete a validatable returns process.

To complete this process in specific regard to returned products that are saleable, the Verification Router Service (VRS) initiative was highlighted by the Healthcare Distribution Alliance (HDA) in its efforts to lead the industry in implementing the act. Essentially the VRS community consists of a third-party routing service, comprising requestors, responders, VRS providers, and a governance body to help manufacturers and distributors work together.

Under the proposals, the responders – ie. the manufacturers – are responsible for providing repository connectivity information to the VRS and providing appropriate responses to the requesters’ (ie. the wholesale distributors) verification requests by matching the product identifier received from the requester with the product identifier in their repositories.

This level of collaborations requires tools for manufacturers and distributors need to work together. And these tools require testing – in minutiae.

Today, various solution providers, including rfxcel are in the process of providing a VRS. By the end of Q2 2018, industry testing is expected to start. The industry testing will consist of two rounds of testing, where there will be updates and modifications to the VRS specification to accommodate learning’s from the first test. Final revisions and refinements of the VRS will go in place with the final report published by the end of Q4 2018. Therefore, the VRS is expected to be available in early 2019, in readiness for the November deadline.

Lessons learned

However, as mentioned, it’s unlikely that the FDA will be lenient with this second deadline. It is therefore important to be aware that the duration of the testing depends on a lot of different things. It is going to be dependent on the readiness of your trading partners to start testing, and be determined by the quality of the data you received. You will need to expect some problems and be able to account for that within your schedule.

Analysing the recent HDA meeting back in February, we have put together our top tips to ensure you meet the upcoming DSCSA deadline:

Start talking with your providers, NOW! If you haven’t started implementing solutions yet or looking into your options, this is the perfect time to start.
If you are selecting vendors, make sure you understand the level of service provided by these providers. Everyone has a different way of managing the implementation process, so it’s not all the same.
Understand the total cost of ownership or the total cost of implementation. Make sure you have resources in the budget for that so you’re not surprised when the project starts.
We recommend that engage your trading partners to mutually understand the impact of your plans. This is probably the most important phase that you’ll need to go through. Your trade partners have different schedules, they may have different commitments to other customers that they are exchanging information with. So as part of this, make sure you understand the proximity exchange and make sure you reach out to your key suppliers in time.
Finally, the HDA does require continued testing implementation regarding serialized items. Make sure that you schedule ample time to test the implementation. Run through the proper test cases with your trade partners as part of the on-boarding process.

To learn more about the DSCSA VRS deadline and rfxcel’s VRS pilot project please contact us.

Legal Note *We are very familiar with the DSCSA requirements and the DSCSA implementation we are not familiar specific trading partners or contracts or business requirements. As a result we do recommend that you have them all reviewed by your legal team to make sure that DSCSA law and DSCSA VRS deadline might apply for your specific situation.