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Materials Tracking & Traceability Software |
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Materials Tracking & Traceability Software |
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Food Safety Modernization Act (FSMA) compliance was recently simplified by make compliance by smaller and mid-sized organizations in the food supply chain much simpler from a technical viewpoint.
This white paper explores these changes in the FSMA requirements.
On October 1, 2024 the FDA modernization activities established a new Unified Human Foods Program with a new model for field operations and more. A part of this new program was to rewrite the guidance documents for FSMA so as to bring them more in compliance with existing industry practices.
Up to October this year, we were working under the premise that the changes required under the Food Safety Modernization Act, FSMA, and especially rule 204, would follow practices similar to those used for pharmaceutical traceability, and rely heavily on the use of GS1, that is Global Standards One, standards, such as effectively mandating the use of EPCIS data files for exchanging traceability data between supply-chain trading partners.
In fact, there is no longer any requirements from the FDA for trading partners in the food supply chain to exchange any traceability data at all.
The other big change is that, rather than being required to maintain an event history database, containing both locally collected traceability event data as well as precursor traceability data from upstream trading partners, that is from your suppliers, all that is required now is to maintain sortable Excel spreadsheets containing locally recorded traceability event data.
The concept is that, if needed, these spreadsheets can be filled out manually, and then provided on demand to the FDA as part of a traceability/recall activity. As a result, there are big changes in what is recommended in the FDA implementation guidance documentation and website.
Excel spreadsheets are in, and automated data exchange is not required, which make life much simpler for the smaller participants in the food supply chain, but there are also some negatives as well.
For more details, please click on Big Changes in FSMA Requirements
