05/23/2018

Less than 9 months to go! Who will be ready for EU FMD or what will it take to make it a reality?

As you are most likely aware, in just under nine months time, the EU FMD becomes a reality, on the 9th of February 2019. Since pharma companies need to supply serialised products to the marketplace, as per the requirements of this directive, many of them progress well towards their final stage of its implementation. However, some companies are less fortunate.

From a general perspective, each pharma company will have many different levels of individual site or line requirements, along with various hardware and software systems, documents, procedures and standards. It all adds up to the fact that these projects, when completed, will have to comply with EU FMD. On a site level, it takes substantial monetary and personal resources, along with quite an extended period of time to execute and complete.

As this is a slow process and each pharma company will have different levels of challenges, based on their, or their customers’ products and compliance requirements; can any of this be simplified to speed up its overall completion? Would a serialisation project benefit from choosing a plug and play approach? This question applies especially to those companies that experience problems while trying to integrate many different types of systems or software.

TQS Fast Track is one such way to achieve timely compliance. It offers a turn-key, fully integrated, automated machine solution for serialising cartons, which comes supplied fully validated. This can also plug-in and connect to any Level 3 software and is available in less than three months.

Expanding into its capabilities, TQS Fast Track will fully track each carton end-to-end and operate with a secure and reliable transportation device, allowing for consistently high quality printed serialised codes. An on-line verification camera will check each print, and if required it can have a Tamper Evident label applicator and a checkweigher. All of these processes are controlled and operated through one HMI, with no teach-in function necessary for print or vision. This machine has a small footprint, is user-friendly, while easy to set up and operate. All of which is designed, manufactured and built in Germany.

TQS Fast Track is an easy to install, validated solution, which is available on a short lead time, with an open standard interface to connect to any new or existing Level 3 software or even to use as a standalone unit. The TQS Fast Track can be adapted to fit many challenging applications in serialisation, while there are other Fast Track solutions available for aggregation too. Could this be what is missing to achieve implementation of EU FMD in time?

Author: Marcus McCarthy, Sales Manager at WIPOTEC-OCS Ireland

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