Future-proof serialization software at FachPack 2016

Supreme efficiency and high level of security

  • Medtracker is easy to implement – even in existing hardware environments.
  • MEDTRACKER is a flexible solution for generating, importing, printing, aggregating and tracking codes in compliance with all currently known international regulations.
  • The basic concept of MEDTRACKER has been in service in security-conscious sectors for many years.

The pharmaceutical industry is contemplating the implications of the EU-wide serialization requirement for drug packages that will be required from February 2019 and almost 1,5 years earlier in the USA starting from November 2017. More new regulations are being adopted all over the world, including in Russia, where the latest drafts demand seamless traceability, including aggregation and automated data queries through a central governmental database. Small and mid-size pharmaceutical manufacturers in particular, but also their packaging service providers seek to implement suitable software solutions to control and map the entire process of serialization and traceability. However numerous challenging questions need to be answered regarding features and functionalities of an appropriate solution: How are existing hardware components to be integrated? Is it necessary to assimilate additional modules and components, e.g. for aggregation? How can maximum data security be ensured? Can a fast-growing and currently inestimable data volume be feasibly managed? And what action can be taken to ensure that future requirements can be accommodated as well, without the need to touch the programming or even switch to a new system?

As a leading supplier of sophisticated individualization and track & trace systems, Atlantic Zeiser is presenting a modular, easy-to-implement software solution for the forthcoming range of tasks related to serialization at FachPack 2016 (Hall 3, Booth 415). Medtracker is a simple and flexible database software solution for generating, importing, managing, distributing, printing and aggregating codes for all international regulations, and includes full capabilities for track & trace and pedigree applications, as required for the USA and other countries. “For many pharmaceutical companies, it is now high time to address the topic of serialization,” says Helmut Schneider, Group Product Manager Packaging at Atlantic Zeiser. “From initial planning to implementation in pilot lines, serialization projects can sometimes take 15 to 24 months to realize. It is crucial for pharmaceutical companies and packaging service providers to invest in a future-proof software solution that can be adapted and extended as necessary. In many cases, high priority is attached to retaining the existing machine inventory.” Atlantic Zeiser has developed the software architecture of MEDTRACKER to be compatible with existing, even multi-vendor hardware, subject to certain conditions being met. Thanks to an extensive interface library, Medtracker is able to control a variety of hardware components, such as camera and printing systems as well as sensors. In view of its real-time capability, Medtracker software also complies with the short response times demanded by packaging lines.

The modularity of MEDTRACKER achieved by the flexible architecture, moreover, facilitates seamless expansion, both for mapping individual workflows and between the different ISA-95 levels. Therefore it is also a natural aspect of MEDTRACKER to allow the connection to and bilateral communication with common ERP systems, which allows e.g. production orders to be transferred with a high degree of automation.

Modular design offers numerous benefits

The modular design of MEDTRACKER allows the fast and efficient implementation across individual machines, entire packaging lines, production sites or even on a multinational company level – all with a single product solution that can be seamlessly expanded. Unlike many customary software solutions, MEDTRACKER is a generic database application also offering the full functionality of a production management platform. As a consequence, all the process steps and functions of hardware modules or entire packaging lines required for serialization can be configured relatively freely, monitored and, in particular, revised at any time in most cases without programming or extensive revalidation.

Simple code aggregation

While maintaining the necessary process security, MEDTRACKER can also control both fully automatic and manual packaging processes, in the context of aggregation and is also able to model logistic procedures, such as repackaging or management of returns. Thanks to its architectual software design MEDTRACKER is capable not only of recording and aggregating data on the usual packaging hierarchies such as case or pallet but also able to generate an infinite number of additional data containers if required, for a shipment for instance.

Proven high-security architecture

To ensure the highest standards of data security, Atlantic Zeiser draws on its wealth of in-house expertise. The company has already been integrating many of the MEDTRACKER software’s fundamental components in security-conscious industrial sectors for several years. As a result, the solution now embraces effective, continuously refined defense measures against criminal hacking by outsiders. In addition, data are exchanged between production operations and facilities in an encrypted format as a general rule, which has by no means been standard practice in the pharmaceutical segment thus far.

All product and logistic information is collected and reliably stored for many years, moreover, for each individual medicine package guaranteeing the uniqueness of each individual code. Thanks to defined user authorizations and functions for data export purposes, the system allows also the fast and easy generation of central audit reports.

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Ute Heiler