Overview
Currently, there are over 40 countries that have either final legislation, legislation in process, or plans to introduce legislation regarding serialization, traceability, and reporting on medicine distribution. Although each market has similarities in its regulatory requirements, the reality is the requirements for each market are unique. Achieving and maintaining compliance requires integration across internal manufacturing and distribution systems and processes, and integration to partner systems and processes, including contract manufacturers, third-party logistics providers, and customers. It is not unusual for a single company to have integrations with 100s of trade partners to meet their compliance requirements. Addressing each market requirement individually has proven unsustainable as one-off approaches are expensive and introduce unnecessary risks to supplying medicines to patients.
TraceLink Global Serialization, Traceability, and Global Platform provide a single platform by which life science companies can meet their global serialization, traceability, and government reporting requirements. Developed and hosted on the Opus Digital Network Platform, the TraceLink solution provides:
- Network: A network of over 280k life science entities that have been onboarded and integrated. These entities can be discovered and linked to the exchange of serialization and traceability information.
- Scalability: High volume transaction processing of billions of serial numbers and events associated with medicine distribution. An active-active deployment model ensures that serialization, traceability, and compliance does not impact the operational efficiency required in medicine manufacturing and distribution.
- Compliance: Individual market and country applications that meet specific country requirements for report generation, data mapping and central system connectivity. A network-tenant solution ensures that new functionality can be rapidly deployed while maintaining backward compatibility with existing partner integrations.
- Ensuring Supply: A unique network-wide data model digitally representing the flow of medicines into and throughout a market or country. This data model can drive collective intelligence solutions to address critical industry issues such as more advanced predictions of pending drug shortages.
Highlights
- Pre-integrated and configured set of solutions and applications to manage serialization and traceability throughout internal and external medicine manufacturing and distribution
- Network of 280k life science entities onboarded, integrated and ready to exchange serialization and traceability information.
- Pricing shown is based on a representative customer and will vary based on your specific needs (markets, supply chain operating model, and other requirements). For a custom quote through private offers, please contact your TraceLink AE or awsmarketplace_sales@tracelink.com.
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Dimension | Description | Cost/36 months |
|---|---|---|
AWS Marketplace Package | Includes platform fees for one country. Additional packages available | $210,000.00 |
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Customer reviews
Serialization platform has secured our supply chain and enables proactive compliance monitoring
What is our primary use case?
TraceLink is used primarily for government regulations to make products serialized and to ensure that products are authenticated, with the main purpose of implementation being to avoid counterfeit products.
A product master is added to TraceLink , and once added, a serial number is generated. The generated serial number is then passed to a line system that prints the numbers, and at the time of dispatch, the number is uploaded to TraceLink. As the shipment starts from the warehouse, it is exchanged with the supply chain, and when the supply chain syncs with the repository called VRS, it has been verified in the USA. For other markets, the data is synced with government portals that ensure product authentication when required.
What is most valuable?
TraceLink offers a rigid platform that is very elastic as per data requirements, along with 24/7 customer service and a knowledgeable team. Recently, TraceLink has launched generative AI for their new product over supply chain, and they are yet to launch it for their existing modules that are in the pipeline.
As a pharma industry, the focus is on product and manufacturing facility and market expansion, and TraceLink helps by providing a good platform so that the business can be concentrated on instead of worrying about platform requirements or development.
What needs improvement?
There is not a need for improvement yet because TraceLink's full offerings are not yet fully utilized, but currently, there are enough features to use.
For how long have I used the solution?
TraceLink has been used for the last six years.
What do I think about the scalability of the solution?
When two or three shipment dispatches are planned, or even more than 20 or 80, each shipment has data that fluctuates between 80 MB to 2 GB with more than 10 to 12 events per unit. TraceLink is very elastic, and whenever there is a huge dispatch planned, there are no hurdles in dispatching data to customers in the supply chain. If anything goes wrong, an email is received from TraceLink before even reaching out to them, showing their proactive approach.
How are customer service and support?
TraceLink offers a rigid platform that is very elastic as per data requirements, along with 24/7 customer service and a knowledgeable team.
If anything goes wrong, an email is received from TraceLink before even reaching out to them, showing their proactive approach.
Which solution did I use previously and why did I switch?
A recent evaluation process found that TraceLink is smooth and easier to use than SAP ATTP, which is why a rating of nine was given.
What other advice do I have?
TraceLink is currently transitioning from their classic portal to the Opus platform, which is very rigid and designed for future expansion, indicating specific improvements that have been seen since using TraceLink.
Currently, TraceLink's AI has a generative approach, and they are working on qualifying and certifying an AI approach with the ISO team, which is still in progress, so a comment cannot be made at this time.
The AI capabilities are not yet released and are under qualification, so updates regarding their accuracy and reliability of output will have to be awaited.
TraceLink is always the preferred choice. The overall rating given to TraceLink is nine out of ten.
Which deployment model are you using for this solution?
If public cloud, private cloud, or hybrid cloud, which cloud provider do you use?
Platform has streamlined pharma serialization compliance and improves global supply chain visibility
What is our primary use case?
In my daily work, when we create the serial number ranges and requests in TraceLink , they are accordingly received, and we get notifications, full links, and everything is updated regularly across global supply chain management. This has been very beneficial for our operations.
Regarding my main use case with TraceLink, I find it a wonderful application. Compared to all other ATTP and RFXA applications, I prefer TraceLink because it is excellent for troubleshooting, serialization events, and reconciliation activities.
What is most valuable?
TraceLink is a user-friendly application that we can easily understand, and it has been helpful to us.
TraceLink has positively impacted our organization as we are using it for European and US markets, including DSCSA and EU FMD. We have had good receiving experiences and there have not been any queries about TraceLink. Overall, it has been excellent.
TraceLink is useful for integration and data exchange with packaging systems and enterprise systems, demonstrating how it has benefited our organization.
What needs improvement?
For how long have I used the solution?
What do I think about the stability of the solution?
What do I think about the scalability of the solution?
How are customer service and support?
Which solution did I use previously and why did I switch?
What was our ROI?
What's my experience with pricing, setup cost, and licensing?
What other advice do I have?
Regarding TraceLink's AI capabilities, I think governance and security are handled well for serialization and end-to-end supply chain. The accuracy and reliability of the output from TraceLink's AI capabilities are very good overall. It provides good help for the system.
My advice for others looking into using TraceLink is that it is a reliable platform for pharma and track and trace serialization management, helping with compliance, serial number handling, reconciliations, and supply chain visibility. However, proper implementation, integration, and training are important for smooth operation.
I would rate this review a ten out of ten.
Reliable serial transfer has ensured uninterrupted production for multiple client projects
What is our primary use case?
I use TraceLink to receive serials from our MAH and transfer them to our serialization system. After we produce the serialized product, we transfer it from our system back to their system through TraceLink . I work as an admin on the system and am responsible for monitoring it. When we receive serials from the MAH company to our serialized system and after we produce the product, we send the serialized product through our system via TraceLink back to the MAH company.
What is most valuable?
The best features TraceLink offers are the sync between the MAH and our serialized system. It operates on time and immediately. When we request serials, we receive them directly with no delay. When I monitor the system, it is simple and easy for me to trace it and troubleshoot any issues. TraceLink troubleshooting is very straightforward.
What needs improvement?
At this moment, I do not have anything for TraceLink to improve because everything works well. When we find any issues, we raise a ticket and the support team resolves it directly.
For how long have I used the solution?
I have been using TraceLink for two years, and we have many projects with TraceLink.
What do I think about the stability of the solution?
Sometimes when our serialized system pushes the serials, there are issues between our system and TraceLink and sometimes between our system, TraceLink, and the MAH company. TraceLink provides detailed information on the issues. During troubleshooting, when we read the alerts and details of these issues, we can determine where the issues are and identify the root cause.
How are customer service and support?
The support team is responsive and supportive.
Which solution did I use previously and why did I switch?
We started using TraceLink directly without prior solutions.
How was the initial setup?
We implemented TraceLink directly because our MAH company uses this system and requested that we use it as well.
What about the implementation team?
We are a partner.
What's my experience with pricing, setup cost, and licensing?
I do not have the price list or setup cost information because the MAH company covered it. We did not pay anything.
What other advice do I have?
TraceLink is the main system for us because we receive serials from our MAH, and without it, we cannot produce the product. TraceLink is vital for us because we cannot produce any product for our client, the MAH, without the TraceLink connection. We need the connection to be operational to receive serials from our MAH partner to our serialized system. After we finish the product, we push the serialized serials back to the MAH through TraceLink. The support team performs well. I rate this review as a 9 out of 10.
Transparent order tracking has supported compliant product serialization and efficient onboarding
What is our primary use case?
My main use case for TraceLink involves product registration, commissioning a file verification, disposition assign, CMO and customer onboarding, and tracking of the orders with our customers.
Regarding product registration, I go to the products tab and provide the product name, which country I am manufacturing in, the generic name of the product, the strength, and the count type such as 100 count, 20 count, or 50 counts. I provide the counts and then the GTINs for the particular product against NDC. I also provide the number of units and number of shipper per case such as bottles per case with aggregation quantities and the SSCC number for that. Additionally, I provide the NDCs and internal material numbers such as NDC 532 and 542, and save it. This process is for product registration.
For tracking orders with my customers, I go to the product track verification tab, and there I can find day-wise tracking. On the current date, I can see how many orders have been released, to which customer, and the quantity released, which I can verify against the PO number. Inside that, it provides the details of which product it is and how long it took to release it. This is part of product verification. If I go to Info Exchange, I can also find information on whether the respective data and files have moved to the customer or not.
In addition to my main use cases for TraceLink , I have to handle CMO onboarding in a manner similar to product registration time, where I provide the GLN of the manufacturers and the GLN of the CMO who is going to process it. I also have to utilize Service Links from the manufacturer to CMO in TraceLink so that the communication between both customers initiates. This is a basic activity we perform for Service Link and assigning activities of disposition, including assigning serial numbers to the required CMO from the manufacturer.
What is most valuable?
The best features TraceLink offers in my experience include order tracking, which is one of the best, and the fact that I have never faced serial number duplicacy in my 12 years of experience with TraceLink, which is commendable. Apart from the basic TraceLink features, there is TraceLink University that provides an overview of different countries and an examination for TraceLink authentication, resulting in TraceLink certified users. Additionally, there is another platform called Opus that provides an enhanced experience.
TraceLink has positively impacted my organization because everything is transparent, allowing us to easily track orders customer-wise and verify serial number statuses, confirming whether serial numbers are assigned or not. This transparency provides a lot of positive support for our day-to-day operations, and I truly appreciate using TraceLink.
What needs improvement?
There are improvements TraceLink can make. For example, the search buttons only function for a particular time frame such as a 30-day limit. When searching for data from six months ago, I must manually select from date to date, which is cumbersome. It would be beneficial to have a one-year time frame for searching easily. I currently find it inconvenient to go back to find older orders using the outdated calendar navigation. Additionally, sometimes the receipt of an order during outbound delivery creation times leads TraceLink to get stuck, stating it cannot communicate with the server, which I believe is an issue from TraceLink's end. Lastly, the report printing feature only allows for printing one page at a time rather than all pages at once, which should be improved.
I would like to add that while TraceLink has other applications called Opus and University, there is little awareness of them, as there are not many ads or training available. We have accounts for Opus, but we could not utilize that application effectively due to a lack of training. Providing training modules for Opus and communication regarding new application modules would be very beneficial for users.
I believe TraceLink needs to adopt the latest AI technologies, as the pharmaceutical industry is advancing in that direction. Many peer applications of TraceLink already incorporate AI, so keeping up with these updates is essential for operational and quality improvements.
For how long have I used the solution?
I have been using TraceLink for the last four years.
What do I think about the stability of the solution?
TraceLink is, in my experience, very stable.
What do I think about the scalability of the solution?
The scalability of TraceLink is excellent; in recent years, I have added many products, and numerous orders get dispatched daily. The application flow remains smooth, which is why I rated it an eight.
How are customer service and support?
My experience with TraceLink customer support is mixed; I sometimes receive a quick response and resolution within one to six hours, while other times it can take two to three days to get follow-up actions.
Which solution did I use previously and why did I switch?
Before choosing TraceLink, we evaluated a different application called Verify Brand, which is an in-built software of Optel solutions. We decided to switch to TraceLink for a more standardized application.
How was the initial setup?
I do not see any challenges with the implementation process of TraceLink; it is standard and managed professionally.
What about the implementation team?
We have in-built experts on TraceLink, such as myself, who primarily handle user training and onboarding. I create accounts for the new users based on our internal processes, and provide them with training on how to operate the TraceLink application, including the options they need to use, how to search, how to export reports, and how to verify various elements and use other platforms such as Opus.
What was our ROI?
I have seen a return on investment with TraceLink because of the SIT application. We are fulfilling orders of our controlled substance products within our ANA Pharmaceuticals premises, which, without SIT, would force us to engage another vendor or 3PL to store and deliver our products, significantly increasing costs and space usage.
What's my experience with pricing, setup cost, and licensing?
Regarding pricing, setup cost, and licensing for TraceLink, I received the complete contract renewal details from the TraceLink team last year. I gathered the necessary and non-necessary information, including the licensing part, for my management's approval. My inputs helped finalize the number of licenses and costs of the applications.
Which other solutions did I evaluate?
Since day one, we have been using TraceLink and have not switched to a different solution.
What other advice do I have?
We use two systems in our manufacturing unit, including an Optel system that is completely integrated with TraceLink numbers. We have been directly integrated with TraceLink since 2016, exchanging serial numbers and commissioning from day one.
TraceLink helps me manage supply chain disruptions or unexpected changes through SIT and Opus. We utilize SIT daily, and if unexpected errors or changes arise, TraceLink provides pop-ups detailing the reasons behind the work stoppage, enabling us to address the issues.
TraceLink supports collaboration between different teams in our supply chain, as we have integrated it with our ERP system, ensuring that activities reflected in our ERP are mirrored in TraceLink after fulfilling the orders.
We do not have any specific metrics to measure TraceLink usage, and I do not follow regular checks.
My advice to others looking into using TraceLink is that if you want a stable application that supports your growing business plans, you should definitely choose TraceLink as your number one option. I rated TraceLink an eight based on its overall performance and capabilities.
Which deployment model are you using for this solution?
If public cloud, private cloud, or hybrid cloud, which cloud provider do you use?
Serialization has ensured compliant drug traceability and supports patient-ready distribution
What is our primary use case?
My main use case for TraceLink is to support the Drug Supply Chain Security Act.
A specific example of how I use TraceLink is that our CMOs receive the serial numbers, and then they print those serial numbers on the actual finished drug product labeled for patients. We then send the data to the 3PL, which receives the product for distribution to either wholesalers or specialty pharmacies.
My main use case with TraceLink is to have a serial number on each unit of sale and to be able to trace the unit.
What is most valuable?
The best features TraceLink offers include the serial number feature, which I believe they do a good job of providing, the community events that they host, which are helpful, and their portal has improved over the years, especially the user interface, though there are more improvements that need to be done.
TraceLink positively impacts my organization because without serial numbers, you are not able to sell your drug and provide that drug to a patient.
The community events help us because they provide insights into challenges whether they are in the US, Europe, or any other country. Depending on the market, we have to be able to adapt to those requirements from the government, with examples in Russia where they are using crypto and in other countries where there might be additional requirements. I think TraceLink has been providing good information back to the community. Currently, the UK is uncertain, and I am still waiting to hear back. I sent a message to the community this week to find out what is happening in the UK regarding serialization.
What needs improvement?
I believe there are more improvements that need to be done on the features, especially around looking up the serial number for quick searches and also the reporting, which needs improvement so that users should be able to go in and get different types of reports and dashboard information that will be helpful.
To improve TraceLink, I think they first need to have a customer call center where people can call in to follow up on issues. Currently, we tend to be emailing, and sometimes it is not clear if someone is working on the issue or when they are going to get back to you. That is critical, and I am saying that not because I have an issue now, but when I do have an issue, I need to know someone is working on it and when they are going to get back to me. If there is a contact, sometimes it is much easier to talk to the person than to send multiple emails back and forth to get something resolved, which is not helpful either because of the different time zones involved.
The needed improvements are around customer service, reporting, dashboards, and country requirements. If that information was available on the website or somewhere where people can reference it, that would be helpful. Then if they had more detailed questions, they can go to TraceLink for clarification.
For how long have I used the solution?
I have been using TraceLink since 2015.
What do I think about the stability of the solution?
TraceLink is stable.
What do I think about the scalability of the solution?
I believe TraceLink is pretty scalable. I have not seen any issues, but I am a small pharmaceutical company.
How are customer service and support?
Customer support could be improved.
I would rate the customer support a seven on a scale of one to ten.
Which solution did I use previously and why did I switch?
I did not use a different solution before TraceLink.
How was the initial setup?
I have to pass on the experience with pricing, setup cost, and licensing because I was not involved in those aspects.
What about the implementation team?
My company does not have a business relationship with TraceLink other than being a customer.
What was our ROI?
I do not have any metrics in terms of money saved or fewer employees needed to share, but the metric I can provide is that it is a compliance requirement. If you want to sell your product, you need to have a serial number on it, so it is not a choice whether I use it or not. While I could work with another competitor to TraceLink, I think TraceLink has been doing a good job, and people tend to use them.
What's my experience with pricing, setup cost, and licensing?
I have to pass on the experience with pricing, setup cost, and licensing because I was not involved in those aspects.
Which other solutions did I evaluate?
Before choosing TraceLink, I evaluated other options in terms of RFXcel, which was another provider that was evaluated but was not selected.
What other advice do I have?
My advice to others looking into using TraceLink is that it is a well-known brand in the industry for serialization. It really comes down to your customer relations manager and your representative and how they are going to support you and get the task done in time. I would also advise customers to start early with the project because there are different issues that come up during the implementation, and starting early gives you time to address them. Otherwise, you are rushing, and it could delay the project. I would rate this review an eight on a scale of one to ten.