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 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.
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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.
Read MoreMedTech
05.09.2022 MedTech News
Legacy Devices in the MDR
Legacy devices are not directly mentioned in the MDR but are defined in the Medical Device Coordination Group document MDCG 2021-25. Accordingly, these are medical devices that were placed on the market after the application date of the MDR in 2021 until May 26, 2024, if certain conditions are met. Thus, circa 80% of the […]Pharma
14.09.2022 Pharma News
Serialization Simplified – tracekey Serialization Manager
For Marketing Authorization Holders (MAH) and Contract Manufacturers (CMO) in the pharmaceutical industry, serialization is a recurring topic. Each batch must be provided with codes, which must be generated beforehand. For companies with high production frequency and generally more resources, this is usually not a problem. Since it is a regular task, one does not […]Read More… from Serialization Simplified – tracekey Serialization Manager
About tracekey
21.04.2022 About tracekey
The advantages of agile working for pharmaceutical serialization
With the Falsified Medicines Directive (EU FMD), a major digitization project was legally imposed on the entire pharmaceutical industry. From manufacturers, contract packagers, marking systems, and line producers to pharmacies – everyone was involved and had to integrate new processes, systems and hardware into their work within a few years. At the same time, a […]Read More… from The advantages of agile working for pharmaceutical serialization