Welcome to tracekey - tracekey solutions GmbH

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.

What We Do

With our cloud 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.

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.

25. Aug. 2021

MedTech: Does Your ERP Cover Everything?

ERP systems offer medical device manufacturers many options for controlling their processes and planning resources. However, they do not cover some use cases such as master data management, as is required in the industry to comply with the MDR. ERP (Enterprise Resource Planning) systems offer numerous possibilities for companies to keep track of figures, data, […]

26. Jul. 2021

MDR/IVDR: Which supportive initiatives are available?

New regulations, such as the MDR and IVDR, not only provide the industry with opportunities like reorganizing and imroving processes. The industry is confronted with several hurdles as well. Companies do not have to solve these on their own. Especially online, there is now a multitude of easily accessible and free resources that support companies […]

23. Jul. 2021

New Whitepaper: 7 Steps to UDI Compliance

In the context of the MDR, UDIs are an essential topic. After all, they not only have to be applied to the product and label itself, but also serve as a key for the EUDAMED and are part of the documentation. We have summarised all information on the different UDI types for you and defined […]

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FAQs

Indonesia: Pharma Serialization Regulations

Indonesia has been working on pharma serialization regulations and their implementation since 2017. By 2025, all prescription drugs must be serialized and equipped with a 2D data matrix code. A QR code requirement for OTC and processed foods, among others, will apply as early as 2023. Title: BPOM Regulation #33/2018 Implementation of 2D barcode in […]

The Six EUDAMED Modules (MDR)

An important component of the MDR and IVDR is the EUDAMED. As a central database, it is intended to create more transparency, bundle information, and serve as an exchange and reporting platform for the individual actors. To this end, it consists of six modules that cover various topics ranging from the registration of medical devices […]

Track-and-trace in Saudi Arabia

In Saudi Arabia, work has been underway since 2015 to make medicines safer and prevent counterfeiting through serialization. Unlike in Europe (end-to-end), a complete track-and-trace system is to being introduced here. Designation: Drug Track and Trace System for Pharmaceutical Products (RSD) Competent authority: Saudi Food and Drug Authority (SFDA) Products: All medicines for humans and […]

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The No. 1 for small and mid-sized businesses

Who We Are

What We Do

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tracekey solutions GmbH

tracekey solutions GmbH

RegTech for Life Science Industry

The No. 1 for small and mid-sized businesses

Who We Are

What We Do

References

Contact

tracekey solutions GmbH