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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
Basic Compliance Pack

Our Basic Compliance pack is your low-cost option to successfully address the Food Traceability Final Rule as it stands today. Key features include:

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

  • Digitize and store your specific CTEs and KDEs in the TagOne cloud via the TagOne Web UI, pre-built Excel/CSV sheets, or 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:

  • Data sharing with Business Partners

  • 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 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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