What is STEPLogic TRACE?
Based on our 30+ years of field experience, we developed STEPLogic TRACE to meet government regulations for track and trace serials in manufacturing and warehousing. For more than a decade, Körber's award-winning serialization software has been the trusted choice for organizations navigating the complexities of DSCSA, FMD, and FSMA 204 compliance.
Drawing from over 30 years of industry expertise, STEPLogic TRACE was meticulously crafted to meet stringent government regulations for serial track and trace in both manufacturing and warehousing environments. Explore its capabilities in action.
Key benefits of STEPLogic TRACE
Serialization regulatory challenges to the Supply Chain
Pharmaceutical industry: Serialization started in the pharmaceutical industry and was designed to eliminate counterfeit medicines from the supply chain. The World Health Organization (WHO) released a statement numerous years ago that potentially up to 50% of counterfeit medicines comprised the global drug market. Governments in the United States and Europe have responded by enacting the Drug Supply Chain Security Act (DSCSA) and the Falsified Medicine Directives (FMD) to secure the supply chain.
Other industries: Additionally, other industries such as Food & Beverage, Electronics Manufacturing, and Medical Device manufacturers will soon be required to serialize their inventory, and track and trace it as moves from manufacturer to distributor, and eventually the retail partner.
- Uniform data standards and interoperability: To comply with government regulations, manufacturers, wholesalers, and retailers must not only incorporate serialization and traceability across their supply chains but develop uniform data standards and interoperability.
- Serial numbers: Serial numbers must be reported to various repository organizations (private companies in the US and government agencies in the EU).
- Integrated or stand-alone solutions: Manufacturers and distributors may experience more benefits when their track and trace solution integrates with their existing warehouse management systems (WMS), but some will require a stand-alone, edge solution.
- Stabilization period:Total compliancy was expected in US pharmaceuticals by year-end 2023, but the FDA has issued a “stabilization period” until year-end 2024.
- Tobacco regulations: Tobacco regulations in the EU went into effect in 2019.
- Food Safety Modernization Act (FSMA 204): The Food Safety Modernization Act (FSMA 204) was enacted by the FDA in January of 2023. This law mandates that businesses who manufacture, process, pack, or hold foods must reach track and trace compliance on January 20, 2026.
Track and Trace inventory across the entire Supply Chain
STEPLogic TRACE for DSCSA, FMD, and FSMA 204 Compliance
With Körber’s STEPLogic TRACE 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, or stand-alone as an edge solution, 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 work with food and beverage, medical devices, and electronics companies to help them meet their track and trace compliance requirements.
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 or FSMA serialization compliance requirements (or equivalent regulations outside the USA), while optimizing your productivity levels.
Johnson & Johnson - DSCSA serialization track and trace in use
Körber’s team of season consultants are warehouse management experts, who specialize in the complex challenges of the pharmaceutical supply chain. The need of our long-time customer, Johnson & Johnson, to meet compliance regulations for track and trace serials in manufacturing and warehousing was a catalyst for the development of STEPLogic TRACE.
Our platform has been in operation for 10+ years and was one of the original ground-breaking software solutions to help a pharmaceutical manufacturer meet all DSCSA guidelines in the United States. It was integral to the first fully serialized pharmaceutical warehouse in 2013 for Johnson & Johnson. Hence, our Supply Chain Innovation Award for STEPLogic TRACE.
We are proactively making constant improvements to the software to give users the ability to design their own processes to capture, validate, and build hierarchies of serialized inventories. STEPLogic TRACE integrates with WMS, WCS, and MES through APIs and an easy configuraton interface in a variety of communication methods.
Körber’s Checklist for DSCSA Compliance
As the November 27th deadline for compliance draws near, the FDA has offered a one-year “stabilization period” for pharmaceutical stakeholders to resolve any challenges they are experiencing with serializing and receiving inventory as it moves along the supply chain. However, stabilization does not mean stopping.
Whether you have already implemented a solution or are just beginning your serialization journey, pharmaceutical manufacturers, wholesalers, distributors, and dispensaries alike will benefit from our checklist.
Körber’s expert supply chain consultants developed this document based on their 30+ years of field experience in pharmaceutical distribution. Download our checklist to get some free advice on how to keep your supply chain moving!
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