FSMA compliance: How software can help you achieve it

As all US fresh food producers and their overseas suppliers should know, from January 2026, there will be a legal obligation to enable highly enhanced tracking of their products across the entire supply chain. This is after the the sunset period ends for FSMA compliance: the US Food and Drug Administration’s Food Safety Modernization Act’s (FSMA) Final Rule on Requirements for Additional Traceability Records for Certain Foods.

Markem-Imaje works with leading global brands especially in the FMCG segment on compliance and traceability needs. For our US customers and their clients, FSMA certification, requiring strict new traceability standards, for certain fresh food products and other FDA regulations like FDA 21 CFR Part 117, obliging preventative controls and product recall protocols, are a major part of their regulatory concerns and priorities.

For this reason, we want to ensure that our customers and readers are fully aware not only of the implications and possible impacts of FSMA compliance, but how they can most easily and effectively fulfil the FSMA Regulations and achieve FSMA certification. Besides having the high-quality, durable marking solutions, to be discussed in our third white paper on FSMA compliance, software is the other vital component in the successful implementation of FDA food regulations.

 

Software for traceability and FSMA compliance

Without the use of software, rapid traceability and the ability to recall potentially contaminated food products within 48 hours, as the incoming FDA food regulations require, become far more difficult and, as a result much slower. With FSMA compliance fast approaching, now is the time to build effective end-to-end traceability into your fresh food operations. For this reason, we have spoken to Stephen Tagg, Markem-Imaje’s Global Software Applications Sales Manager and Corporate Software Solutions expert about how software can ensure your FSMA compliance, and give peace of mind to your brand and consumers.

Stephen has spent six years to date at MI working with numerous FMCG producers to protect their brands with software solutions. Before that, he worked with manufacturing execution software (MES) giants Rockwell Automation and Schneider Electric as well as automation software developers and in a leading FMCG as a systems engineer. Altogether, Stephen has over 25 years’ experience in working with software and other industrial production systems.

For this reason, we have prepared a white paper containing an in-depth interview with Stephen on how software can ease your path to FSMA compliance and thus FSMA certification which you can download from this page. This is the second in our FSMA Regulations downloads. If you have not already read our paper on the FSMA and its implications for fresh food producers and processors, see the blog. If you produce or sell fresh food products in the US, and also frozen fish and seafood, don’t get left behind in this important regulatory change; it could cost you and your brand dearly.