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TagOne Compliance Link Consider FSMA 204 Done

TagOne Compliance Link is our flagship FSMA 204 solution suite that helps food companies across the supply chain easily identify, capture, validate, store & share relevant CTEs and their KDEs.

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 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 5 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

  • Secure data repository for one-click reporting

 

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.

Supplier Link
TagOne Supplier Link

Simplified Supplier Integration 

Supplier Link, a part of the Compliance Link solution suite, has been designed and built with only one thing in mind: to make data sharing from a diverse supplier base as simple as possible. 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 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.

 

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Free Access for Your Suppliers

Your suppliers have full access included with your subscription fee.

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.

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.

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 for your customers.

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.

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Integration Engine
TagOne Integration Engine

Advanced Data Sharing

The Integration Engine is another key Compliance Link Solution suite component. It has been built to address the B2B system integration requirements between supply chain partners across the food industry. Unlike the Supplier Link, the use case for Integration Engine is more focused on the data sharing needs of larger, more IT-mature companies who already may be capturing and storing many of FSMA 204 required Master & Transaction data in existing systems. Key features below:

  • 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.

  • Supports leading protocols like AS2, SFTP, FTP/FTPS, HTTP/HTTPS 

  • Supports multiple data exchange formats like JSON/XML

  • Supports leading data exchange methods, including REST APIs

  • Supports leading industry standards like GS1(EPCIS)

  • Pre-built Connectors with leading industry systems like SAP

  • Highly secure client certificates/authorization tokens used for security and authentication purposes

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TagOne Integration Engine

Internal Systems Integration

Via the 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 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.

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Compliance Cockpit
TagOne Compliance Cockpit

Advanced FSMA 204 Reporting

The success of regulatory compliance programs often boils down to the quick and easy availability of compliance data. This can be a significant challenge, particularly when meeting the requirements of a complex regulation like FSMA-204 which demands detailed traceability data for a food item, identified at the lot level, within 24 hours .

 

With our extensive experience in the traceability compliance space spanning nearly two decades, we have not only been there and done that, but we have also gained a deep understanding of what it takes to simplify compliance reporting. This knowledge has led us to develop our Compliance Cockpit, a solution that not only facilitates 1-click FDA reporting but also equips our clients with multiple exception management and error handling reports, ensuring they are always in control of their compliance requirements. 

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5 Step Data Life Cycle

To ensure comprehensive reporting, we follow our five-step data life cycle of identifying, capturing, validating, storing, and reporting. i.e., Before the final reporting step, we first identify the data that needs to be captured, followed by the actual data capture step, after which it is validated based on our rules engine. Only after this is the data stored in TagOne and finally reported on, as and when required. Each step is equally important and needs to be thoroughly planned and executed. 

 

When a recall or an FDA audit occurs, it's possible that the food item and lot queried came from a packing location, warehouse, or manufacturing facility that your company just acquired and has yet to be fully integrated into your company processes or central systems. What would you do then? Let's walk through what we discussed about the data life cycle.

1. IDENTIFY

Identify your FTL items and their data (Master and Transaction) and determine where they reside (including location and system). If the data already resides in another system, TagOne's Integration Engine will pull it into TagOne as your central regulatory repository.

2. CAPTURE

Capture this data using one of TagOne's 7 different ways of data capture.

3. VALIDATE

Validate if this data abides by the pre-set rules that ensure its viability and correctness.

4. STORE

Store the data in TagOne, your company's single source of truth for all relevant FSMA-204 data.

5. REPORT

Report as needed, which could be 1-click reports for the FDA like the FSMA-204 traceability report, receiving, shipping, or transformation CTE reports OR exception management reports like the TLC/Quantity/Item Mismatch.

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