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 […]

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DSCSA Requirements for 2023

DSCSA Requirements

Beginning November 27th, 2023, FDA’s Drug Supply Chain Security Acts (DSCSA) requirements will change. In the future, pharmaceutical products in the U.S. will be required to be traceable at the lot and package level.  Moreover, part of the regulation also states that all parties must participate in data exchange, verification, and tracking of pharmaceuticals. For […]

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Cloud and cybersecurity in pharma

Cloud und IT Sicherheit

The cloud has become omnipresent. Whether we are streaming media, communicating with friends and colleagues, or simply storing data. Almost everything is done via cloud providers. But it often sounds like a buzzword to make something more interesting than it actually is. What exactly is the cloud? What types are there? And is it secure? […]

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Pharma Serialization in China

Pharma Serialisierung in China

As the country with the largest population, China also has one of the largest pharmaceutical markets in the world. In 2020 nearly 35 billion U.S. dollars were generated in pharmaceutical imports, and the trend is upward. In order to counteract counterfeiting and protect patients, the regulations of pharma serialization in China were adjusted in the […]

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Case Study: Stegemann (CPO) together with Level 3 partner Mettler Toledo

How does the cooperation between tracekey and the Level 1-3 providers work? We talked to one of our customers, Stegemann Lohnverpackung & Logistischer Service e.K. and the line manufacturer and Level 3 provider Mettler Toledo about our joint processes and work. The complete implementation of pharmaceutical serialization requirements, such as the EU FDM, includes not […]

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FAQ on pharmaceutical serialization

Efforts are being made worldwide to stop the dangerous trade of counterfeit medicines. To tackle this problem pharmaceutical serialization laws have now been enacted in numerous regions all over the world. Depending on the statutory requirement, serialization in the pharmaceutical industry is enforced differently. What all regulations have in common is the assignment of a […]

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What is the advantage of active alert management for me as a pharmaceutical company?

EMVO AMS, Alert Management for Pharma

Alert Management & EMVO AMS | Alerts keep the industry busy – ever since the start of the active commissioning of the serialization activity. The system, which is supposed to protect patients from counterfeit medicines, produces many error messages from the very beginning when verifying medicines in the pharmacy. These are almost exclusively false positive […]

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Counterfeiting? Medical Product Alerts in the securPharm System

Alerts in securPharm, NMVS, EMVO

Alerts in securPharm and EMVS Approximately two years after the EU-wide Falsified Medicines Directive (FMD) came into force, many false-positive alerts make it difficult to find actual falsifications. Both, the national systems (NMVS) and the EMVS are working on reducing these alerts. Although the number of false alerts in the European anti-counterfeiting systems has decreased […]

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