tracekey solutions GmbH

RegTech for Life Science Industry

The No. 1 for small and mid-sized businesses

In a connected world, the structured exchange of data with international partners and authorities is essential. As a partner of the life science industry, we support you managing digitalization.

Personal. Smart. Agile.

Smart Serialization
Complex requirements of the (pharmaceutical) industry easily implemented

 

Global Compliance
Agile solutions for international requirements: EU-FMD, DSCSA, Russia, MDR etc.

Digital Twin
One digital duplicate for each product individual – linked into the digitally connected supply chain

Cloud Solutions
Tailor-made modules for your situation: mytracekey HospitalDirect & mytracekey CONNECT

Website of the Alliance for Cyber Security

Who We Are

We are agile, committed and dedicated team players. We are experts for digitalization in highly regulated industries. We are the best choice for companies who are looking for software and service.

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What We Do

With our solutions, market compliance requirements of the Life Science industry can be met quickly and efficiently. Our standardized and proven best practices create individual added value.

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References

Our customers come from various sectors of the pharmaceutical industry. Especially small and medium-sized companies have found the right serialization partner in tracekey.

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Career

Would you like to become part of our agile team? Then take a look at our careers page to find out what you can expect from tracekey and what vacancies we currently have.

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MedTech

EUDAMED M2M Connection
24.10.2024 MedTech News

EUDAMED and the M2M connection – when does it make sense?

At the end of 2024, the European Commission (EC) published guidelines on data exchange with EUDAMED. They describe the three upload variants: Manual upload, bulk upload and a machine-to-machine (M2M) connection. For this purpose, their advantages and disadvantages are presented. The commission also provides an overview of the conditions under which each upload variant is […]

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Pharma

Verified by GS1
07.11.2024 Pharma News

Real Time Data Exchange with Verified by GS1

In today’s globalized economy, access to reliable and up-to-date product information is becoming increasingly crucial. GS1 helps to make this product data reliable. It provides global standards and systems that ensure the accuracy, consistency and transparency of data. These systems include barcodes, the Global Data Synchronization Network (GDSN) and the Real Time Data Exchange with […]

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About tracekey

It Security and Information Security at tracekey solutions
30.09.2024 About tracekey

IT and Information Security at tracekey

Hackers, phishing emails, ransomware – IT security and information security now play a crucial role for all companies. For us as software developers, it is even more important because we not only secure our internal systems but also continuously adapt the software we develop to the latest security standards. Our Chief Information Security Officer (CISO) […]

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Further topics

battery law and digital product passport
04.12.2023 Other

The New Battery Law and the Digital Product Passport

The extraction and processing of raw materials is responsible for half of all greenhouse gases globally. These are necessary for the linear model of our economy that has been established for decades. Earth’s resources are extracted, processed into products, and soon afterward discarded. As a result, a significant amount of resources is simply lost. Improving these […]

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