Food Manufacturers/
Processors
For Food Manufacturers/Processors, the FSMA 204 ruling means another step forward in your continued quest towards food quality and safety perfection. At the minimum, to comply with FSMA 204, all you need is to capture Key Data Elements (KDEs) that support your Receiving, Transformation and Shipping Critical Tracking Event (CTEs).
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.
As the entity making the final consumable food item sold via the RFEs (Retail Food Establishments), you will now need to capture all relevant info about the ingredients that go into the food, the details of the processing/manufacturing event where you mix the ingredients together to create the final food item, and then finally capturing the shipping info of the final food product to your customers. Many of these KDEs you may already be capturing today.
FSMA 204 KDEs
Receiving Events
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Traceability lot code for the food
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Quantity and unit of measure of the food
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Product description for the food
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Location description for the immediate previous source (other than a transporter) for the food
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Location description for where the food was received
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Date you received the food
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Location description for the traceability lot code source or the traceability lot code source reference
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Reference document type and reference document number
FSMA 204 KDEs
Transformation Events
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New traceability lot code for the food
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Location description for where you transformed the food (i.e., the traceability lot code source), and (if applicable) the traceability lot code source reference
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Date transformation was completed
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Product description for the food
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Quantity and unit of measure of the food
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Reference document type and reference document number
FSMA 204 KDEs
Shipping Events
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Traceability lot code for the food
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Quantity and unit of measure of the food
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Product description for the food
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Location description for the immediate subsequent recipient (other than a transporter) of the food
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Location description for the location from which you shipped the food
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Date you shipped the food
How TagOne Helps
Food Manufacturers/Processors
Address FSMA 204
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TagOne will work with you to help incorporate missing KDEs (if any) to your existing business i.e., make changes to your existing processes/systems or other
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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
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TagOne has an advanced manufacturing/processing module that can capture product Recipes, Batch manufacturing details including input ingredient lots, quantities, quality reports, supporting documentation, pictures etc.
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Open APIs based on leading industry standards to easily connect and exchange data with other systems in your ecosystem
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Pre-built connecters to leading industry solutions like SAP, QuickBooks, Shopify, Big commerce
For Larger Manufacturers/Processors
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TagOne will integrate with your existing MES, ERP, Warehouse Management or Logistics systems to automate the capture of KDEs supporting the Receiving, Transformation and Shipping CTEs
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TagOne will be your Central Regulatory Repository & the Single Source of Truth for all things FDA
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TagOne supports integration with leading-edge solutions
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:
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Self-setup of your company account on the TagOne traceability cloud
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Digitization and store your specific CTEs and KDEs in the TagOne cloud via pre-built excel sheets or via the TagOne mobile app
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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:
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Inventory Management
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Master Data Management
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Document Management
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Ability to add supporting info beyond the KDEs to each transaction (Documents/Pictures/Data)
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Traceability reports (one up/one down)
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Recalls and Returns
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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.
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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.
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We will work with your team to identify any process gaps and work to come up with pragmatic solutions to address them.
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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.
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We will ensure that this information is securely stored on our AWS cloud so you can access it on an “as needed” basis.
The TagOne Value
Central Regulatory Repository
TagOne is your Single source of truth for all FDA-related traceability data and documents.
Traceability Data Digitization
TagOne will enable you to Capture, Store, and Share relevant traceability data on an “as-needed” basis.
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.
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.