Pharmaceutical packaging serialization: The clock is ticking – and not just in the EU
- How to use MEDTRACKER to reliably comply with even complex serialization requirements such as those for the U.S., Russia, and other important markets.
The serialization of pharmaceutical packaging which will be mandatory throughout the EU starting in February 2019 is already attracting notice. But attention should also be paid to other important markets: For instance, the U.S. requires that prescription medications be serialized by November 2017. On top of that, new regulations are constantly being added – to the Russian market, for instance, in which, for some medications by 2018 and for all by 2020, complete traceability, including aggregation and the capability of automated data queries in a central government database, will be required. This entails huge challenges for small and mid-sized pharmaceuticals manufacturers in particular, but also their packaging service providers, with respect to the implementation of suitable software solutions: How can existing hardware components be integrated? And how can companies ensure that they can fulfill future requirements without needing reprogramming and the high costs of revalidation that would entail?
Atlantic Zeiser, a leading provider of sophisticated individualization and track and trace systems, has developed a modular, easy-to-implement software application to meet the upcoming challenges: MEDTRACKER makes it easy to flexibly generate, import, manage, distribute, print, and aggregate codes for all internationally valid legal regulations – including complete tracking and tracing for track and trace or pedigree applications that are required in countries such as the U.S. starting in 2023. Atlantic Zeiser developed MEDTRACKERs software architecture so that, under certain conditions, it is compatible with existing, heterogeneous hardware from third-party suppliers and can centrally store both the actual serialization data and audit-relevant information. Thanks to a comprehensive interface library, MEDTRACKER can be integrated into conventional ERP systems without any problem, allowing a higher level of automation to be achieved for the creation of production orders. In addition, it supports interfaces such as EPCIS from GS1, which is becoming increasingly important as networking within the logistics chain intensifies.Modular structure offers many advantages
MEDTRACKERs modular structure allows implementation across individual modules, entire lines, production facilities, and companies – with a single, scalable product. Unlike many conventional software options, MEDTRACKER is a generic database application with the full functionality of a production management platform that allows all process steps and functions of hardware modules or entire packaging lines that are necessary for serialization to be defined, monitored, and adapted relatively freely, at any time, and without programming effort.