With the upcoming FSMA-204 regulations, much discussion has been generated on how companies should use their existing IT infrastructure. Some companies have been frantically trying to get their Enterprise Resource Planning (ERP), Warehouse Management Systems (WMS), or other solution providers to upgrade their solutions in time. While others are quickly realizing that regulatory compliance is a constantly changing web of complexity that should be best kept out of existing operations.
There is no 100% right or wrong answer to this question, but at TagOne, we are firmly entrenched in the second camp. Our perspective is based on our deep roots in the traceability compliance space. There are a few things companies need to keep in mind.
Regulatory Compliance requirements are ever-changing
Although the core compliance requirements may remain the same, industry interpretation and accepted standards may undergo multiple changes over time, driving the need for constant system upgrades.
Force-fitting these requirements into your existing systems is fraught with risk, not to mention the additional ERP/WMS consulting charges you will need to pay to develop, configure, and support them.
FSMA-204 Compliance is not an Enterprise solution, but a Supply Chain one
For example, Companies must capture their suppliers' shipment KDEs, which are beyond enterprise-specific solutions, and also report from a central repository with all the KDEs(Supplier and enterprise) in one place.
TagOne is a specialized Regulatory Compliance System designed to Identify, Capture, Validate, Store, Share, and report on all FSMA-204 KDEs. Unlike other solutions, TagOne can directly capture these KDEs within the application or pull them from your company's diverse data sources (via the TagOne Integration Engine). This ensures a comprehensive and accurate central data repository for reporting.
As you embark on your FSMA-204 journey and make your solution decision, please ensure you do a comprehensive TCO (Total Cost of Ownership) assessment. You will quickly see the value of a unique solution like TagOne, which has been custom-built only to address the FSMA-204 requirements.
TagOne will be your Central Regulatory Repository and your Single Source of Truth for all things FSMA-204.
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