Trust the FDA Traceability Compliance Experts
For over a decade, we've been helping companies identify and overcome FDA traceability compliance challenges, across industries.
Helping Companies
Address FSMA 204
The FDA’s upcoming FSMA 204 rule establishes additional traceability record-keeping requirements (beyond what is already required in existing regulations) for persons who manufacture, process, pack, or hold foods the Agency has designated for inclusion on the Food Traceability List. These additional record-keeping requirements are outlined in the Requirements for Additional Traceability Records for Certain Foods (Food Traceability) rule and are intended to make it easier to rapidly and effectively track the movement of food to prevent or mitigate a food-borne illness outbreak.
At the core of this rule is a requirement for those who manufacture, process, pack or hold foods on the Food Traceability List (FTL) to establish and maintain records containing Key Data Elements (KDEs) associated with different Critical Tracking Events (CTEs).
TagOne Compliance Link for FSMA 204
The TagOne team firmly believes that successful compliance with FSMA 204 regulations hinges on two critical factors:
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How well can a company identify, capture, and securely store records containing vital Key Data Elements (KDEs)?
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Can they seamlessly share this invaluable information with their business partners?
Navigating the complexities of the food industry is no small feat, given the vast differences between companies in the supply chain. From their size and operational complexity to their IT readiness and financial resources, there's clearly no universal remedy or one-size-fits-all approach to solve these multifaceted challenges. This is precisely where TagOne steps in.
Armed with more than 17 years of expertise in the supply chain traceability landscape, and having successfully traversed the entire FDA traceability regulation cycle in the pharmaceutical domain (the DSCSA Law), the TagOne team is uniquely positioned to guide you through the turbulent waters of the Food Traceability Final Rule.
Our cutting-edge cloud-native traceability management system has been custom built for the Food and Natural Products Industry to ensure that a diverse array of customers can seamlessly capture, validate, store, and share the critical data that supports their FTL products within the supply chain. We've fine-tuned our system to match the industry's unique processes (CTEs) and key data elements (KDEs), making end-to-end traceability an achievable reality.
TagOne’s system was built to be user friendly, making it accessible to companies of all shapes and sizes. Whether you're a mammoth corporation or a nimble startup, TagOne's solution suite can be tailored to meet your unique needs. We’re here to serve both ends of the market and everything in between, providing versatile solutions that empower your business.
Enabling Data Capture Across the Supply Chain
The TagOne solution is set up to provide comprehensive traceability across supply chains by enabling companies to easily capture, validate, store, and share key data elements as a food item moves between different companies, from its origin to the final consumer. TagOne provides multiple options to capture this data, aligned with a company's IT and operations maturity.
For example, companies with more advanced IT systems can leverage TagOne’s Integration Engine to capture relevant traceability data from both internal and external systems (from business partners). On the other hand, other, less IT-savvy companies can use simpler options like TagOne’s Web UI, Mobile, or our pre-built Excel/CSV templates to fill up and upload data to TagOne in minutes. All FSMA204-specific CTEs (Like receiving, transformation, shipping, and packing) and their supporting KDEs are covered in the TagOne solution.
Capture Traceability Data Your Own Way
TagOne offers customers 7 easy ways to capture relevant traceability data.
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.
Data Sharing with Business Partners via
TagOne Integration Engine & Supplier Link
TagOne Integration Engine
The TagOne Integration Engine is set up 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 Supplier Link
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 the IT systems to enable automated system-to-system data exchanges. For these scenarios, the TagOne Supplier Link provides companies with an easy-to-use application that can be accessed via the Web 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.
TagOne Integration Engine
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Multiple APIs are available to ensure a smooth exchange of KDEs related to Packing, Receiving, Transformation, and Shipment Events between TagOne and non-TagOne systems.
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Supports leading protocols like AS2, SFTP, FTP/FTPS, HTTP/HTTPS
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Supports multiple data exchange formats like JSON/XML
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Supports leading data exchange methods, including REST APIs
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Supports leading industry standards like GS1(EPCIS)
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Pre-built Connectors with leading industry systems like SAP
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Highly secure client certificates/authorization tokens used for security and authentication purposes
Internal Systems Integration
Via the TagOne Integration Engine, companies capturing traceability data in existing systems can directly link them to TagOne via multiple integration options. TagOne will be your central regulatory repository and add missing data points, link together, validate, and report specific KDEs required by the FDA in seconds.
External Systems Integration
The TagOne Integration Engine can quickly and securely integrate with your business partner systems (suppliers and customers) in different ways. For example, with our open pre-published APIs, customers can first test/simulate the working of this integration, after which real-time data exchange can be initiated.
TagOne Supplier Link
Strong relationships start with great first impressions, and the relationship between food manufacturers and suppliers is no different. In an era where the FDA still allows the use of paper records, the role of technology and data digitization cannot be understated. These are the linchpins that will enable supply chains to meet the demands of the final rule. But for companies lacking the expertise or advanced systems, it's a formidable challenge. They're faced with the daunting task of seamlessly identifying, capturing, storing, and sharing crucial data with their partners, all without disrupting their existing operations.
Introducing TagOne Supplier Link, a groundbreaking solution meticulously designed to revolutionize the food supply chain. It's tailor-made to cater to the distinct needs of smaller and mid-sized companies, ensuring they're not left behind in the digital transformation of data capture, validation, storage, and sharing. This elegant solution is simple yet powerful. With TagOne Supplier Link, we've created a bridge that allows companies to tackle these challenging requirements with ease, helping them thrive in the ever-evolving landscape of the food supply chain. It's your key to unlocking a future where compliance, efficiency, and seamless data management come together effortlessly.
Network-Based Model with One-Time Sign-Up
Say goodbye to complex onboarding processes; TagOne Supplier Link welcomes you with a straightforward one-time sign-up.
100% FSMA 204 Compliance
We've got you covered, ensuring your compliance with all the Critical Tracking Events (CTEs) and supporting Key Data Elements (KDEs) for various supply chain roles, as prescribed by the FDA.
Multiple Access Options
Whether you prefer the comfort of your desktop, the versatility of a tablet, or the convenience of a mobile device, TagOne Supplier Link has you covered.
Flexible Data Capture and Sharing
Choose your weapon of choice—whether its our intuitive web user interface, the familiarity of Excel, CSV files, or even the mobility of our dedicated mobile app, we have 7 options for you to capture data
Full Master Data Functionality
Seamlessly manage your essential master data, including business partners, items, and locations, ensuring nothing falls through the cracks.
Auto-ASN Translation Service
Streamline your operations with our automatic Advance Shipping Notice (ASN) translation service that instantly translates your shipment data into ASNs.
Putting Data Capture & Share To The Test
Hey there, it's me, everyone's favorite tomato, Tracee! We've talked a lot about how TagOne's Integration Engine and Supplier Link will help streamline all compliance requirements for FSMA 204. Now, let's help you visualize the power of TagOne with examples of how it would work to address the FSMA 204 requirements for a Large Food Processor and a Large Retailer!
In the next few sections, we will cover WHAT the problem we are solving is for these disparate companies, WHY a solution like TagOne is necessary, and HOW we accomplish our goal.
WHAT
There's a Need for Close Collaboration Across the Food Supply Chain
The FDA’s FSMA 204 rule requires close collaboration between business partners across the food supply chain to enable easy data exchange about the food items they buy and sell to ensure full traceability.
The TagOne Integration Engine and Supplier Link work seamlessly together with the rest of the TagOne solution suite to enable this collaboration.
Large Produce Processor
The Business Scenerio:
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The processor's multiple suppliers ship raw materials (Cherry Tomatoes, Romaine Lettuce, English Cucumbers) to the processor.
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Produce processor receives the produce raw material from their suppliers, who are a mix of big and small companies themselves.
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After receiving, the produce processor mixes(transforms) different Lots of these raw materials together to create a new finished product called Salad Kit.
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Ships this finished product to its customer, the Retailer.
Salad Kit Example: Supplier ships FTL raw material to Processor who creates Salad Kit and ships to Customer (Retailer).
WHY
Under FSMA 204, the FDA has listed down a list of comprehensive KDEs across multiple CTEs that need to be captured and exchanged between business partners across the supply chain to ensure compliance.
The TagOne Integration Engine and Supplier Link work seamlessly together with the rest of the TagOne solution suite to ensure all this complex data is captured, validated and shared across the supply chain.
As part of this business process, we will need to cover the following CTE’s which in totality add up to a large number of KDEs:
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Supplier Shipping KDEs
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Processor Receiving KDEs
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Processor Transformation KDEs
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Processor Shipping KDEs
HOW
The food industry needs a highly flexible solution that can address the massive disparity in companies across the supply chain, be it in size, business complexity, IT systems maturity, budget, etc.
The seamless collaboration between the TagOne Integration Engine and Supplier Link within the broader TagOne solution suite showcases a remarkable level of comprehensiveness. This synergy effortlessly caters to the requirements of both small-scale enterprises and large corporations, as well as addressing the demands of simple systems to more complex ones. TagOne supports multiple ways for its disparate set of customers to identify, capture, validate, store, and share data across the supply chain, be it via more advanced methods like AS2/ Open API connections with existing systems of records or via the simple-to-use TagOne Supplier link UI and Excel/CSV files.
System View Across Suppliers & Processor
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Small Suppliers typically use the TagOne Supplier Link to send ASN to Processor with relevant KDEs
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Large Suppliers typically leverage TagOne’s Integration Engine to send ASN to Processor via TagOne APIs
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Produce processor uses an SAP system to run operations within its own organization including:
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Raw material receiving,
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Salad kid preparation (transformation event)
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Shipping of finished product (salad kit) to the customer (Retailer)
Putting It All Together
The TagOne Validation & Reporting Engine
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Small Suppliers use TagOne Supplier Link to send ASN to Processor with relevant KDEs
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Suppliers use multiple data entry options like Web UI, via the Excel/CSV templates, Tablet, Mobile to enter/share this information.
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Large Suppliers leverage TagOne’s Integration Engine to send ASN to Processor via TagOne APIs. They can choose from multiple options to exchange data with TagOne
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Option of using leading protocols like AS2, SFTP, FTPS.
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Option of multiple data exchange formats like JSON/XML.
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Option of using multiple data exchange methods including REST APIs.
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Covers leading industry standards like GS1(EPCIS).
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The produce processor uses an SAP system to run operations within its own organization, including raw material Receiving, salad kit preparation (Transformation Event), and Shipping of finished product (salad kit) to the customer (Retailer)
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TagOne Integration Engine’s pre-built SAP connectors pull in relevant receiving, transformation & shipping KDEs from the Processor SAP system into the TagOne’s Validation & Reporting engine where the data is validated and stored.
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FDA Reporting via TagOne
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TagOne consolidates the Supplier ASNs, Processor Receiving, Processor Transformation, and Processor Shipping at the Item & TLC (Traceability Lot Code) level, validates this data against pre-built business rules and thereafter generates the FDA report in a matter of seconds.
