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For over 15 years, we've been helping companies identify and overcome traceability compliance challenges across industries. Let us help you navigate your FSMA 204 compliance journey and lay the foundation for a better tomorrow.

FSMA 204 compliance begins here

Some people are calling the FDA's upcoming FSMA 204 rule the largest single imposed change on the global food supply chain in history. This compliance requirement is estimated to impact nearly half a million global food establishments. 

 

At the rule's core are additional traceability record-keeping requirements for persons who manufacture, process, pack, or hold foods that the FDA has designated for inclusion on the Food Traceability List (FTL). For FTL foods they handle, these persons must establish and maintain records containing Key Data Elements (KDEs) associated with different Critical Tracking Events (CTEs) and provide the requested information to the FDA within 24 hours or within some reasonable time to which the FDA has agreed.

TagOne Compliance Link Diagram

TagOne Compliance Link for FSMA 204

Companies impacted by this ruling may be feeling overwhelmed and considering this work as an additional burden and a complex undertaking. But the reality is that complying with these requirements will become a breeze with a little bit of planning, a little discipline, and some help from TagOne.

 

With our TagOne Compliance Link solution we promise to take the complexity out of your FSMA 204 compliance journey. By leveraging our decades of traceability compliance experience, we have custom-built the solution from scratch, addressing the diverse needs of each partner type, across the supply chain. In our view, in an industry as big and diverse as food, a one-size-fits-all all kind of solution just cannot work.

We believe a comprehensive FSMA 204 compliance solution needs to address 4 key things which we define as part of our compliance wheel. A complete understanding and coverage of:
 

  • All roles across the supply chain

  • Identification of the appropriate data types

  • Flexible data capture options catering to different business user types

  • Seamless data share capabilities

 

TagOne Compliance Link for FSMA 204 checks all the boxes. In fact, we can confidently say that in addition to helping you address the immediate FSMA 204 requirement, it will also help you use this investment as building blocks for the future, to drive competitive advantage.

SUPPLY CHAIN ROLES

Helping companies across the supply chain address FSMA 204

Supply chain partners dealing in FTL foods be it Harvesters, Coolers, Packers, Wholesalers, Processors, Distributors, Retailers, Restaurants or others, will now need to capture, store and share additional information about these food items. 

What this means is that for specific pre-defined events performed across different roles in the supply chain (called CTEs), companies now need to capture and share specific pre-defined data elements (KDEs) defining that event. These CTEs include events like Harvesting, Cooling (if applicable), Packing, Shipping, Receiving and Transformation and supporting KDEs include data elements like Commodity (Food Item) name, Lot Number, transaction location, transaction dates, quantity, unit of measure, etc.

Although this might sound like a lot of different KDEs defining multiple CTEs, the FSMA 204 data can be broken down into three main data types:

 

  • Product Data

  • Location Data

  • Transaction Data

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DATA IDENTIFICATION

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FSMA 204 CTEs & KDEs organized in one place

These three data types fully describe a food item's movement as it progresses through the supply chain via tracking events and ensure the comprehensive traceability the FDA seeks to drive.

Product Data

In its simplest form, product data is information that helps identify the food item in more detail to avoid confusion about the commodity being tracked. This includes the product's name, brand, variety, packaging size, style, etc. This information is part of what the industry calls a Master Data element (Product/Item Master). I.e., the information has to be captured once and can be referenced repeatedly regarding the food product in question.

Location Data

Location data is meant to identify all the locations the food item has traveled over its life cycle, from the time of harvest (as in the case of a Raw Ag. Commodity) all the way to where the Retail Food Establishment (RFE) makes it available to consumers for final consumption. Typical location data includes physical location address or coordinates and key contact information like business name and phone number for all locations where the food product was handled. Like product data, location data is also part of a company's Master Data (Location Master).

Transaction Data

The transaction data is what ties the food item’s (product data) journey across the supply chain locations(location data), together. Each critical event (Harvesting, Cooling, Packing, Receiving, Transformation, Shipping) is uniquely defined by a set of KDEs assigned to them, as the food item moves through the supply chain. Examples of typical transaction data include KDEs like event date, event location, quantity & unit of measure (for the food Product) and Lot Number.

DATA CAPTURE

Capture traceability data your own way

The TagOne solution is set up to make data capture a breeze for our customers. Our solution provides 7 easy ways to help them easily capture Key Data Elements to support relevant Critical Tracking Events, as a food item moves between different supply chain partners across the supply chain. This is a vital first step to ensure a company’s compliance with FSMA 204, and an area TagOne has greatly focused on over the past few years. 

WEB UI

Simple to use UI that can be accessed and viewed via a web browser and used across different mediums like a desktop, laptop, or tablet.

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DATA SHARE

Ensure seamless data exchange with your business partners

Once the relevant KDEs have been captured and stored for the different CTEs specific to a company's supply chain role, the next vital step is to share shipping KDEs with customers as efficiently as possible. This is a core requirement of the FSMA 204 ruling, and this is where TagOne's Integration Engine and Supplier Link solutions come in to make life super easy for our customers.

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The TagOne Integration Engine has been built to help customers address direct system-to-system data exchange requirements with TagOne. This could be linking their internal systems to TagOne or integrating with their business partners (external systems) to ensure the easy capture, storing, validation, and sharing of KDEs covered under the FDA’s Food Traceability Final Rule. TagOne’s Integration Engine supports leading data exchange protocols like SOAP, SFTP and AS2, data exchange formats like XML, JSON and is fully compliant with GS1 standards. EDI transactions between partners are fully supported.

The TagOne Supplier Link has been custom-built to address the FSMA 204 compliance requirements of smaller and medium-sized companies that do not have IT systems to enable automated system-to-system data exchanges. For these scenarios, the TagOne Supplier Link provides companies with an easy-to-use web-based application that gives them multiple options to collect, store, and share FSMA 204 relevant KDEs applicable to CTEs their company is responsible for. For example, for distributors, this could be capturing KDEs for Receiving and Shipping, while for food processors, it would be Receiving, Transformation, and Shipping.

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Check out our FSMA 204 compliance packages

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"When we started our business,  we knew we wanted to do it the right way, but didn't know where to begin.  TagOne showed us the right path forward"

-Eric Vander Hyde, Co-Founder
Bluestem Botanicals Organic Farm

Track & trace thought leaders

The TagOne team is 100% focused on solving Supply Chain Transparency challenges across multiple industries. The company was co-founded by TJ Gupta and Manish Gupta (no relation) who together combine for over 32 years of industry experience in the traceability space.

 

The team is driven by the vision of global, inter-connected supply chains, across industries and across borders. We believe this is our tomorrow. We’ve spent over four years turning this vision into reality, building out our award winning, SaaS based, Blockchain-enabled TagOne solution suite, from scratch. This unique traceability management system delivers comprehensive seed-to-sale transparency to the food and natural products supply chains.​

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