The tracekey cure against serialization headache:

tracekey offers an intuitive and ready-to-use serialization solution for the pharma industry

Big challenges ahead tend to cause headaches: with the EU regulation 2011/62/EU, the pharma industry faces that kind of challenge. But there is a convincingly easy cure for serialization headache.  tracekey guides and supports you during the serialization process with IT expertise.

The issue of Data Security is one of the main triggers for headache. But no problem, with the right partner. The tracekey-solution emphasizes Data Security and compliance with all regulatory requirements. We offer a worldwide 24/7-service for our clients, standard interfaces with straightforward ERP-integration and a flexible cloud system, with a transparent and fair pricing system.

Pharma serialization on fast forward

A job begun is half done with tracekey. Instead of time-consuming and cost-intensive project, we can launch our base system after only 20 days. Afterwards, you have a fully operating end-to-end serialization system for your pharma products at hand: every important function, from generating serial numbers to reporting, is ready to use. Individual adjustments can then be made in flexible project stages, so you can keep track about the costs.

Serialization without side effects

tracekey acts effectively. Our cloud-based SaaS system does not require a time-consuming on-site installation or complex system integration. Our prefab process patterns reduce the implementation effort immensely.

All data is processed and stored according to German law regulation. We additionally make sure, that all regulatory requirements are complied with at all times.

We know that you have to keep an eye on the costs at all times. So we developed a serialization service that charges you solely for the use of the service, based on the amount of administered serial numbers. No further costs for Hardware, Software, Support or Updates will occur. Still, we will keep you updated on technical and legal requirements. Thus, further adjustments will not cause further headache.

 

Selected Customer References:

Background

With the EU regulation No. 2016/161 EU of 09.02.2016 serialization becomes the top issue of the pharmaceutical industry. This is because the regulation demands that until 09.02.2019 all prescriptive and some OTC drugs must have an individual serial number on the packaging and prove their intactness to the patient. Hence, serialization is the distinct identification of pharmaceutical products in the supply chain from manufacturer to pharmacist. Thus, the counterfeiting of medicines – responsible for millions of deaths worldwide – are prohibited.

Get more information about the directive at our blog.

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