FSMA 204 Requirements | Retailers & Grocers
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Retail Food Establishments
(Retailers/Grocers)

For RFEs, traditional industry challenges like tight margins, high transaction volumes, low shelf-life of perishables (i.e., need for speed to move items from receiving to POS), and lack of trained warehouse workers, have stalled many traceability initiatives in the past. TagOne has you covered.

Helping the Food Industry Address FSMA 204

At TagOne, we believe comprehensive supply chain traceability is a journey where each company should choose its own path to its final destination. But this path should ideally start with small, baby steps.

 

In our view, the FSMA 204 ruling, via its industry-wide compliance mandate, will empower impacted companies to take this first small step. The word we use is empowered because post-FSMA 204, companies will have the choice to continue pushing towards their end-to-end traceability goal and set up for future success or not.

FSMA 204 shouldn’t add too much burden on your existing operations,  TagOne has your company fully covered. At the minimum, in order to comply with FSMA 204, all you need is to capture Key Data Elements (KDEs) that support your receiving and shipping Critical Tracking Events (CTE’s). Many of these KDEs you may already be capturing today.

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FSMA 204 KDEs Receiving Events

 

  • Traceability lot code for the food

  • Quantity and unit of measure of the food

  • Product description for the food

  • Location description for the immediate previous source (other than a transporter) for the food

  • Location description for where the food was received

  • Date you received the food

  • Location description for the traceability lot code source or the traceability lot code source reference

  • Reference document type and reference document number

FSMA 204 KDEs Shipping Events

 

  • Traceability lot code for the food

  • Quantity and unit of measure of the food

  • Product description for the food

  • Location description for the immediate subsequent recipient (other than a transporter) of the food

  • Location description for the location from which you shipped the food

  • Date you shipped the food

  • Location description for the traceability lot code source or the traceability lot code source reference

  • Reference document type and reference document number (maintain only)

How TagOne Helps RFEs 
Address FSMA 204

  • TagOne will help you strategize how to incorporate missing KDEs (if any) to your existing business, i.e., make changes to your existing processes/systems or other
     

  • TagOne supports capturing, storing, and sharing KDEs supporting the Receiving and Shipping Critical Tracking Events (CTEs) in multiple ways

  • TagOne Enterprise, the most advanced traceability system in the market, is set up to help you capture all the relevant downstream KDEs via the following:
    - Desktop

       - Mobile

       - Tablet

       - Pre-built excel templates

       - Directly from your existing systems (in case you’re  already capturing some/all of this data across different locations/systems) via our open API framework OR using our pre-built connectors to leading industry solutions like SAP, QuickBooks, Shopify, Big commerce

For Larger Retailers

  • TagOne will integrate with your existing Warehousing and ERP systems to capture CTEs via our open API framework or using our pre-built connectors for leading Industry solutions like SAP.
     

  • TagOne supports integration with leading-edge solutions
     

  • No need to make expensive upgrades to your existing warehouse operations and IT systems supporting your warehouse - Leverage TagOne to capture KDEs supporting the receiving and shipping CTEs
     

  • TagOne can also be used by your small suppliers to record their shipping events and send these events digitally which you can use to record your receiving events. 
     

  • TagOne will be your Central Regulatory Repository & the Single Source of Truth for all things FDA

Beyond FSMA 204

Compliance aside, there have always been great reasons for Retailers/Grocers/Distributors of food to focus on comprehensive Traceability across their supply chains. Food Safety + Quality + Brand Protection + Brand Differentiation and many more.

TagOne FSMA 204 Compliance Packages

Basic Compliance Pack

Our Basic Compliance pack is your low-cost option to successfully address the FSMA 204 ruling as it stands today. Key features include:

  • Self-setup of your company account on the TagOne traceability cloud
     

  • Digitization and store your specific CTEs and KDEs in the TagOne cloud via pre-built excel sheets or via the TagOne mobile app
     

  •  One-click FDA reporting in a matter of seconds

Compliance+ Pack

Our Compliance+ pack will give you all the functionality of your basic pack PLUS you'll get the following features:

  • Inventory Management

  • Master Data Management

  • Document Management

  • Ability to add supporting info beyond the KDEs to each transaction (Documents/Pictures/Data)

  • Traceability reports (one up/one down)

  • Recalls and Returns

  • Audit Logs

TagOne FSMA 204 Advisory + Roadmap Services

The TagOne team fully understands that comprehensive traceability is a journey and we will support you every step of the way.
 

  • Our traceability process consultants will work with you to map your existing processes to the Critical Tracking Events (CTEs) outlined in the proposed rule and identify all their supporting KDEs.
     

  • We will work with your team to identify any process gaps and work to come up with pragmatic solutions to address them.
     

  • We will conduct onboarding sessions for your TagOne users to ensure they fully understand the workings of the system and are easily able to capture the relevant KDEs against the mapped CTEs.
     

  • We will ensure that this information is securely stored on our AWS cloud so you can access it on an “as needed” basis.

FSMA Complianc Packages

The TagOne Value

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Central Regulatory Repository

TagOne is your Single source of truth for all FDA-related traceability data and documents.

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Traceability Data Digitization

TagOne will enable you to Capture, Store, and Share relevant traceability data on an “as-needed” basis.

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Traceability Reports in Seconds

On a button-click, fetch the TagOne Traceability Map view or Table view report based on Item name/Lot#. This is all you will need in the case of an FDA inquiry.

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Traceability Consulting

TagOne is not only your tech traceability platform of choice but our traceability experts will help you navigate this traceability journey every step of the way.

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