Case Study | Implementing serialization successfully

“This project created a best in class approach to deploying serialized packaging lines.”

Head of Technology, Takeda

Customer

Takeda is a patient-focused, innovation-driven, global pharmaceutical company that builds on a distinguished 230-year history, aspiring to bring better health and a brighter future to people worldwide. The network of Takeda spans over 70 countries and regions worldwide including Japan, the United States, Europe, Latin America, Africa, the Middle East and the Asia Pacific Region. Takeda’s pharmaceutical products are marketed in about 100 countries worldwide, including partnerships (marketing alliance partners). Takeda has manufacturing facilities across the globe as well, including Japan, Russia, Poland, Germany, Austria, Brazil, Ireland, USA and Denmark.

Executive Summary

International pharmaceutical manufacturer Takeda faced the task of implementing serialization and aggregation on over sixty globally distributed packaging lines. They were looking for a global vendor that would be able to create a standardized and repeatable process for Takeda’s unique product identifier (UPI)—or track and trace—project. Configurable software, zero custom code and deep domain expertise were required to get the job done properly and to reduce down-time of packaging lines.

The Takeda and Systech partnership started with a pilot in Brazil, to deploy serialization and aggregation across all lines there. The project was successful, and Takeda made its broader corporate selection based on the experience in that region. There were also joint projects following in Taiwan, managed out of Japan, which led to the decision for Systech.

Systech met Takeda’s expectation with an easy configurable software and a fully standardized packaging line set-up including all hardware components. In addition, they offered a robust set of implementation configuration documentation, based on thousands of line implementations Systech has been involved with. Takeda and Systech finally developed a standardized, repeatable team process for all line projects.

"The project team managed to enable individual line serialization and aggregation projects to be completed in two weeks."

Challenge

Takeda was looking for serialization solutions to address current and future needs that would also efficiently address new regulatory requirements as they emerge in all their markets. As data management is critical for all serialization initiatives, Takeda needed to implement a track-and-trace platform to enable bi-directional communication to and from the packaging line and enterprise systems. SAP is Takeda’s standardized enterprise software platform, and the serialization solution needed to work seamlessly with it.

Manufacturers who invest in productized, configurable, and expandable serialization solutions that leverage a standardized platform are well-positioned to deploy serialization. They can also take advantage of future opportunities and are able to respond more quickly and cost-effectively to new demands. These solutions prepare manufacturers for the future while also keeping the total cost of ownership (TCO) under control. Takeda also took this into account when looking at possible solutions. 

Solution

Systech’s serialization platform was selected as Takeda’s standard global serialization deployment.

In the end, the projects were successful, and the Takeda/Systech approach worked well. Key to success was the overall standardization and modularization—of products, software, line equipment, and processes.

Systech has developed a library of prepackaged modules to meet a wide array of packaging scenarios and serialization requirements. These Packaging Integration Modules (PIMs) can then be added to Systech’s core solution to meet the requirements of each unique packaging line. Each module can be standalone or added with other modules allowing clients to design and build a solution for now that is expandable over time. Modules can be reused across multiple deployments to minimize risks, costs and downtime.

Given over 60 lines at Takeda, standardization, configurability and reusability were critical to minimizing implementation time and reducing project risks.

Configurable serialization software is designed with elements that can be assembled and realigned to quickly accommodate changing demands without requiring code rewrites. This eases handling multiple code schemas to comply with various regulations, enables in-house personnel to maintain the solution, and speeds implementation. In contrast, customized solutions are rigid, making them difficult to implement and modify. By simply making configuration changes rather than rewriting code, configurable solutions minimize the need to perform line re-validations. As a result, manufacturers like Takeda see less line downtime, increased productivity and reduced costs.

Adding serialization technology goes along with new packaging processes at individual sites which must be accommodated by the enterprise information technology (IT) infrastructure. Serialization creates the need for the packaging environment and the IT environment to communicate back and forth to each other in new ways. Takeda needed to make sure that data integrity is protected as it goes to its SAP enterprise environment. Also the flow of data coming down to the packaging level and through the packaging and serialization software should not slow down product throughput.

It was decided early on in the project to use Takeda’s SAP Enterprise platform to provide master data and production work orders. So the solution fully utilizes that as a 100% automated SAP process. The combined system will process those available work orders automatically. The solution is highly integrated as every line at every site is using the SAP master data production work order, which is sent down for execution by the Systech solution. It also interfaces and leverages Takeda’s SAP infrastructure for overall serial number management.

Benefits

Competitive advantages

“This technology is really innovative,” affirms Johanson. “We have pitched it to other customers and the reaction is pretty universal: they like how easy it is to use and the fact that, beyond traceability, there’s the potential to add consumer engagement, which is increasingly desirable in marketing.” As it is 100% digital, relationships can be built with end consumers by allowing them to verify product authenticity. From here, the brand can serve up information such as when and where the product was made, what it is made from, its sustainability rating, promotional offers, etc. “There are lots of opportunities to further develop this offer to new customers,” concludes Johanson. “Our capability with this e-Fingerprinting technology differentiates us as a supplier.”

Systech technology allows brands to assign a unique digital identity to every item that is impossible to counterfeit—without changing their artwork or printing process. Through an e-Fingerprint®, every product becomes connected, giving partners and consumers the ability to verify authenticity, track products and engage at any point in the supply chain.

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