Comply with FDA's FSMA 204 requirements easily with the traceability compliance experts
SaaS based, FSMA-204 compliance software, custom built for the food industry. It empowers companies to easily identify, capture, validate, store & share FSMA 204 relevant CTE’s and their KDE’s for FTL products, as required by law. Solution includes proprietary SAP S/4HANA and SAP Extended Warehouse Management software package that automatically pulls in FSMA-204 data from your SAP systems into TagOne, with no/minimum effort from your SAP team.
By TagOne, LLC
Overview
Fully preconfigured solution will get food companies FSMA 204 ready in weeks
Depending on your role in the food supply chain, the solution will set you up to easily capture and share KDEs relevant to your CTEs and ensure your FSMA 204 compliance.
SAP customers DO NOT need to make any system changes to get FSMA-204 compliant
Comes with our proprietary SAP S/4HANA and SAP Extended Warehouse Management pre-built software package that will automatically pull in FSMA-204 data from your SAP systems into TagOne, with no/minimum effort from your SAP team. Our solution designers are ex-SAP leaders who have spent nearly 25 years in the SAP ecosystem.
Easily network with business partners to receive & share FSMA 204 KDEs
Enable your suppliers to capture and share FSMA relevant KDEs with you in 7 easy ways, using Supplier Link. Similarly, Customer Link provides multiple easy ways for your customers to receive your shipment KDEs as ASNs and additionally address receiving, transformation and shipping on their end.
Details
Solution type
Extensions and Add-ons
Industry
Cross-Industry, Retail, Consumer Products, Wholesale Distribution, Agribusiness
Compatibility
Works with
SAP Business Network Freight Collaboration
Features
Central data repository and single source of truth for your traceability data
Will collate, connect & report on data across your supply chain. It provides multiple ways for customers to capture FSMA 204 relevant KDEs including web/mobile UI, excel/CSV uploads, OCR, mobile scanning, B2B integration engine and a remote data entry service option.

Partner Link provides easy options for non-EDI partners to share FSMA-204 KDEs
Partner Link has two major components 1)Supplier Link helps suppliers easily capture shipment KDE & share them as ASNs with their customers 2)Customer Link help customers, automatically receive incoming ASNs from suppliers.

Compliance Cockpit for 1-click FDA and exception management reporting
Provides advanced reporting capabilities including 1-click FSMA 204 reports for the FDA, and multiple exception management reports like the ASN/Receiving mis-match, missing ASN, pending receiving ensuring you stay on top of exceptions & are always FSMA 204 compliant

Plans and pricing
TagOne Compliance Link for FSMA 204 Core
Compliance Link for FSMA 204 - This is the core solution component that acts as your central FSMA-204 data repository and traceability compliance control center
Compliance Cockpit for FDA FSMA-204 reporting & alert management
Supplier Link for easy supplier data share
Integration Engine for advanced system to system data exchange
SAP S/4HANA, SAP Extended Warehouse Management automation package for bringing FSMA-204 KDEs over from SAP to TagOne
TagOne Compliance Link Core covers all functionality you need to comply with FSMA 204 regulations including 1-click FDA reporting. You can buy bigger or smaller packages depending on your project size
Covers Receiving, Transformation and Shipping CTEs (Critical Tracking Events) as outlined by the FDA under FSMA 204 for Retailers, Wholesalers, Manufacturers and others.
Includes Supplier Link Functionality that will ensure your suppliers have over 6 different ways in which they can send you their Shipment KDEs
- Minimum contract 1 year
Compliance Link for FSMA 204 - This is the core solution component that acts as your central FSMA-204 data repository and traceability compliance control center
Compliance Cockpit for FDA FSMA-204 reporting & alert management
Supplier Link for easy supplier data share
Integration Engine for advanced system to system data exchange
SAP S/4HANA, SAP Extended Warehouse Management automation package for bringing FSMA-204 KDEs over from SAP to TagOne
TagOne Compliance Link Core covers all functionality you need to comply with FSMA 204 regulations including 1-click FDA reporting. You can buy bigger or smaller packages depending on your project size
Covers Receiving, Transformation and Shipping CTEs (Critical Tracking Events) as outlined by the FDA under FSMA 204 for Retailers, Wholesalers, Manufacturers and others.
Includes Supplier Link Functionality that will ensure your suppliers have over 6 different ways in which they can send you their Shipment KDEs
Technical Information
| Solution type | Extensions and Add-ons |
| Category | Supplier Management |
| Industry | Cross-Industry, Retail, Consumer Products, Wholesale Distribution, Agribusiness |
| Works with |
SAP Business Network Freight Collaboration |
The following information is provided by the publisher and applies to the latest app version available on the SAP Store. SAP does not control these policies and procedures; the publisher is solely responsible for the accuracy of the provided information.
| Deployment |
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| Operations |
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The following information is provided by the publisher and applies to the latest app version available on the SAP Store. SAP does not control these policies and procedures; the publisher is solely responsible for the accuracy of the provided information.
| Security |
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| Compliance |
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| Privacy policy |
SAP's privacy policy is not applicable to the use of this app. Please refer to the privacy policy provided by this app's partner. |
Resources
FDA Global Traceability Challenge Winner - Submission Video
TagOne for Retailers & Grocers
TagOne for Wholesale Distribution
TagOne for Food Manufacturers
Publisher
TagOne, LLC
TagOne is a leading SaaS based, FSMA-204 compliance software, custom built for the food industry that empowers companies to easily identify, capture, validate, store & share FSMA 204 relevant CTEs and their KDEs for FTL products, as required by law. TagOne will be your central regulatory repository for all your traceability data and will capture traceability data directly in the application or seamlessly integrate with customer systems like SAP ECC, S/4HANA, SAP EWM, other WMS, MES systems and pull in relevant data as needed to ensure compliance. The TagOne team has been in the traceability compliance business for over 17 years and has built Compliance Link from scratch to addresses traceability requirements of large Fortune 500 type companies or specific needs of small, less IT savvy ones. TagOne has won several industry recognitions like FDA's Global Traceability Challenge & NBJ's supply chain transparency award in 2021
