We are at PharmaTech!

tracekey is attending the PharmaTechExpo in Kiew from 17. to 19. September. In cooperation with our partner Propix, we will present our Level3 solution mytracekey CONNECT and our pharma serialization solution mytracekey PHARMA.   Visit us for more details at booth A-2/1. […]

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In focus: UDI international

In 2017, the European Commission launched the MDR and thus also the Unique Device Identification (UDI). Europe is not alone in this. The concern to make medical technology products safer is also being implemented in other countries with corresponding initiatives or is in the planning phase. The WHO and other organizations have been working for […]

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Manufacturers must not lose sight of UDI

Just a year ago, an extension of the deadline for the implementation of the MDR was under discussion, which was desired above all by the manufacturers. The deadlines remained unchanged, which was quickly determined. However, the question of how to stem the upheaval in the medical technology industry remained unanswered. The biggest concern is probably […]

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Serialization in Russia: More than just a security measure

The system for implementing the EU-FMD has been productive for about five months. The EMVO has just reported that 40% of pharmaceutical manufacturers in Europe are still not or not fully connected to the system. It calls on the national authorities to punish such infringements. However, some of the manufacturers are already preparing for the […]

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We are partners at GS1 Germany UDI Conference

GS1 Germany in cooperation with its partner network organizes a two-day conference on Unique Device Identifiers (UDI) in connection with Medical Device Regulation (MDR). The UDI Practice Day is intended to provide medical technology companies with comprehensive knowledge about MDR-UDI through workshops, lectures, and panels and at the same time provide them with practical solutions […]

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RegTech in the Life Science Industry

In a highly regulated environment, appropriate IT solutions are needed. A new generation of IT companies has therefore established itself, particularly in the finance sector. The so-called RegTechs offer efficient IT solutions for the financial markets that are adapted to strict regulations, but regulatory pressure is also increasing in many other industries. The term RegTech […]

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Why our customers would recommend us

Based on the principle that good cooperation is always based on a constructive discussion culture, we asked our customers how satisfied they are with tracekey. Some of the questions were particularly important to us: How satisfied are they with our system in live operation and how will the EU-FMD be evaluated after the national systems […]

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Successful implementation & customer visit at Kreussler Pharma

Kreussler

The Chemische Fabrik Kreussler & Co. GmbH with its pharmaceutical division became a tracekey customer almost one year ago. Both partners celebrated the successful completion of the implementation project for Kreussler’s business activities in the US with a customer visit. Together with tracekey, Kreussler implemented the DSCSA guideline and adapted its production to the US […]

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SaaS: Good for us, even better for our customers

An editorial by Gerald Wenzel, CEO From now on, the tracekey “perspective” series contains texts by our employees on important topics in the industry. Gerald Wenzel gives his opinion on SaaS. Our business model is based on the Software as a Service (SaaS) principle. However, decentralized, digitalized work does not only suit our actual product but […]

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Blockchain is not a business case

An editorial by Daniel Althoff, Product Manager From now on, the tracekey “perspective” series contains texts by our employees on important topics in the industry. Daniel Althoff gives his opinion on the much-discussed Blockchain. >>When I first had to deal with the term “blockchain” professionally, I sat in a meeting with consultants and anti-counterfeiting experts. […]

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