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FSMA Compliance

Our Promise is to Make Your FSMA 204 Compliance Journey Easy 

For over a decade, we've been helping companies identify and overcome FDA traceability compliance challenges, across industries.

How TagOne can help

With over 17 years of experience in the tech traceability space and having gone through the full cycle of the FDA traceability regulation in the pharmaceutical industry (the DSCSA Law), the TagOne team is uniquely positioned to help you navigate the tricky Food Traceability Final Rule waters. 

Our cloud native, traceability management system has been custom built for the Food & Natural Products Industry, tracking the industry’s unique processes (CTEs) and key data elements (KDEs) making end-to-end traceability a reality. One of TagOne’s main focus areas is ease of use so that companies can easily capture, store and share relevant data supporting their FTL products in the supply chain.

Keep in mind that although the FDA does permit paper records, technology in general and data digitization more specifically will be key for your company to address the final rule.

TagOne FSMA 204 Compliance Packages
FSMA Complianc Packages
FSMA 204 Compliance Link - Basic

Our Compliance Link Basic pack is your low-cost option to get you started on your FSMA 204 Compliance journey. The focus is to help you digitize and store your specific CTEs and their defining KDEs in the TagOne Traceability Cloud. Key features include:

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

  • Basic Master Data Management - Business Partner, Item

  • FDA FSMA204 CTE Management - Receiving, Transformation, Shipping, Harvesting, Cooling, Packing

  • FDA FSMA204 KDEs Management ---> Capture + Store

  • Multiple Data entry options - Web UI, Excel, CSV, Mobile 

  • No Data sharing/exchange option with your business partners 

  • One-click reporting of Key Data Elements linked to your Critical Tracking Events

FSMA 204 Compliance Link - Core

Our Compliance Link Core pack provides all the functionality you need to successfully address your FSMA 204 requirements. As part of this, you get all the functionality of your Basic pack, plus lots more:

  • Option of both Self-service-based or traditional 1-1 onboarding option depending on your company's needs 

  • Advanced Master Data Management - Business Partner, Location, Item, Item Group.

    • Create Business Partners & Invite Business Partners to join the platform directly from your TagOne login

    • Create your multiple ship-to and ship-from locations via Location Master and provide suppliers access to create their own ship-from locations from their profile

    • Leverage Item Group functionality to group items based on common characteristics for faster reporting 

  • FDA FSMA204 CTE Management - Receiving, Transformation, Shipping, Harvesting, Cooling, Packing

  • FDA FSMA204 KDEs Management ---> Capture, Validate, Store, Share

  • Document Management

  • Multiple Data sharing/exchange options with your Business Partners

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

  • Excel-based, One-click FDA reporting in seconds that will make you fully compliant with the regulations

    • Additional Visual Map report & pdf download option

FSMA 204 Compliance Link - Advanced

Our Compliance Link Advanced pack is the answer to your path Beyond FSMA 204 Compliance needs. Not only will this solution package help you successfully navigate FSMA 204, but also set you up to take your company brand to crazy new heights. As part of this, you get all the functionality of your Core pack, plus the following:

  • Inventory Management - Location-based inventory management solution that will help you track quantities of items & their Lots at the most detailed level 

  • Recalls and Returns - Fully automated Recalls & Returns solution including RMA functionality and workflow configuration options

  • Audit Logs

  • TagOne Engage - Content management suite that

TagOne Food Traceability Final Rule 
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.

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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