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DSCSA Serialization Track and Trace

Körber’s innovative track and trace application enables organizations to comply with government regulations – such as the Drug Supply Chain Security Act (DSCSA serialization) in the USA and the Falsified Medicines Directive (FMD) in the EU – that are designed to eliminate counterfeit goods across supply chains, particularly in pharmaceutical, medical devices and tobacco.

DSCSA serialization regulatory challenges

With the World Health Organization estimating that 50% of drugs sold online are fraudulent, the challenges are clear for manufacturers and distributors:

  • To comply with government regulations, manufacturers, wholesalers and retailers must incorporate serialization and traceability across their supply chains.
  • Serial numbers must be reported to various repository organizations (private companies in the US and government agencies in the EU).
  • Distributors may experience more benefits when their track and trace solution integrates with their existing warehouse management systems (WMS).

Total compliancy, whereby items can be tracked, traced and recorded from the manufacturer all the way through to the retail partner, is expected in US pharmaceuticals by year-end 2023. Tobacco regulations in the EU went into effect in 2019.

Solution Sheet

Körber DSCSA Serialization Track and Trace

Comply with regulations and eliminate counterfeit goods

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Tracking and tracing across the entire supply chain

With Körber’s application, you can easily track, trace and manage serial numbers on products as they pass through your facility. These numbers can then be collated and reported to the various repository organizations.

Our software can be integrated into your WMS to make your facility compliant. Also, by eliminating counterfeit products you’ll be saving money and, in the case of pharmaceutical supplies, improving people’s lives in terms of the medical treatment they receive.

As well as pharmaceutical and tobacco businesses, we also work with electronics companies to help them meet their track and trace compliance requirements.

Our software can be integrated into your WMS to make your facility compliant. Also, by eliminating counterfeit products you’ll be saving money and, in the case of pharmaceutical supplies, improving people’s lives in terms of the medical treatment they receive.

As well as pharmaceutical and tobacco businesses, we also work with electronics companies to help them meet their track and trace compliance requirements.

Key benefits

Easy to integrate

Our solution will easily integrate with your current WMS and any other operational systems you are running.

Easy to personalize

Built in our own software development platform, so you can easily develop your own code and personalize settings. 

Repository friendly

Simply add a new repository to the system whenever you do business with another country.

The Körber difference

We don’t believe in a one-size-fits-all approach, because each node in the supply chain has its own unique compliance requirements. We’ll provide your organization with a highly adaptable and flexible solution that has the right track and trace capabilities to address your current and future DSCSA serialization compliance requirements (or equivalent regulations outside the USA), while optimizing your productivity levels.

The work Körber carries out is vital in terms of ensuring sick people receive the correct drugs. I’m very proud of that, plus the fact that we’re helping organizations across the pharmaceutical supply chain to address FDA serialization challenges.

Bob Kennedy,
Körber

DSCSA serialization track and trace in use

Snapshot

Fast relief from the track-and-trace headache

How Johnson & Johnson found a comprehensive solution for cradle-to-grave tracking in the distribution center

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Johnson & Johnson

Enabling DSCSA compliancy, our solution was integral to the first fully serialized pharmaceutical warehouse in the US.

Related Content

Why you need to prepare for 2023’s pharmaceutical DSCSA today

Now's the time to start thinking about how regulations around the drug supply chain cold impact your business years down the line.

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Whitepaper

Serialization beyond pharmaceuticals

Learn how serialization can be utilized in the food and beverage industry

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Case study - Serialization Pharma Giant

Pharamaceutical company reduces number of counterfeit drugs entering the world

How a serialization solution brings compliance to one company for a total investment of 70% less than originally estimated

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