WBDL – what does that actually mean?

WBDL was ist das eigentlich?

Hospital pharmacies are frequented quite differently from public pharmacies. In hospital pharmacies, large quantities of Rx drugs are delivered and distributed in the hospital every day – all the drugs that are needed in daily hospital life. In connection with the requirements of the European Counterfeiting Directive (EU-FMD), this means that a large number of […]

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Crisis: Why you are simply better off with a CS Team

Customer Success Team tracekey solutions

The Corona crisis currently means working from home for many of us. This does not necessarily make working as a team any easier. You are stuck in online meetings with your own team, you have to share your WiFi with your 15-year-old, and the cat is always sitting on the keyboard. Working with external service […]

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10 Steps to Start Your Serialization Journey

Do you need a new and suitable pharma serialization provider? Changes in your serialization journey or process require a lot of time and a good plan. Especially in the beginning, it could be hard. Therefore, always remember to start planning early and go step by step. You need help to comply with EU Falsified Medicines […]

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Whitepaper: Digital Twins in the Pharmaceutical Industry

In the pharmaceutical industry, Digital Twins are being used to combat product counterfeiting. They not only offer added value for the industry but also ensure greater patient safety. In this white paper we answer the questions about how exactly Digital Twins are used in the pharmaceutical industry and what we have learned from the implementation […]

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After Serialization: What Does Pharma 4.0 Mean?

Analyzing, automating, data integrity, patient centricity, data mining, process optimization – Pharma 4.0 is versatile. But what is meant by this and why does digitalization still have room for improvement in the pharmaceutical industry?  Pharma 4.0 is part of the Internet of Things (IoT). The term describes the part of the IoT that affects the […]

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Why you should rely on a central data management system for UDI-MDR

A single point of truth (SPOT) for data or document management is a must in highly regulated markets combined with increasing digitalization. Even small and mid-sized companies can hardly avoid this if they want to keep up with the market. There are numerous small and mid-sized companies (SMEs) with just a few or niche products […]

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20+ terms about MDR/UDI you should know

The medical device industry does not have much time left to implement the regulatory requirements of the Medical Device Regulation (MDR). By implementing such complex regulations, there is a need for clarity on what´s meant by the various terms. In the numerous provisions of the UDI regulations alone, many terms need to be known. We […]

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OTC Serialization is now also a topic

Pharmaceutical companies specializing in the production of over-the-counter drugs (OTC) have not been affected by pharmaceutical serialization so far. This is now changing for companies that are also active on the Russian market. The serialization requirements in Russia are much more complex than those of the EU-FMD. The so-called EU Counterfeiting Directive has been in […]

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All About the UDI Regarding MDR

The Medical Device Regulation (MDR) is an EU directive that will come into force on 26 May 2020 (edit: postponed to 2021) and represents a further large-scale revolution in the industry. In addition to some reclassifications and high demands on data management, Unique Device Identifiers (UDI) on medical devices will also become mandatory. UDI labeling […]

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Crypto-Code and language barriers: Serialization in Russia and China

The implementation of EU-FMD  is not the only track&trace initiative to protect against counterfeit medicines. Many projects around the world are more or less based on similar standards but are all aimed at protecting patients and making supply chains counterfeit-proof. I.e. Russian Crypto-Codes and the serialization requirements in China. Russia and China are two countries […]

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