The additional traceability recordkeeping requirements proposed by the FDA will affect many food and beverage manufacturers and retailers in 2021. With aggressive deadlines and few exceptions, the proposed rule makes paper-based compliance systems obsolete. The FDA is calling this rule "a major milestone," and they take it seriously.
While limited to certain foods, the proposed FSMA 204 rule aims at standardizing the data elements and information that companies must establish and maintain, along with information they need to pass along in the supply chain. This landmark proposal paves the way for the industry to adopt and leverage more digital, tech-enabled traceability systems going forward.
If finalized as-is, the rule requires companies to provide electronic documentation for certain Key Data Elements (KDEs) for Critical Tracking Events (CTEs) within 24 hours of the request. The request for accurate and updated records on short notice will put enormous pressure on organizations that have yet to embrace digital transformation.
Watch this on-demand webinar to receive answers to your most pressing questions about the proposed FSMA 204 rule from Bryan Armentrout, Founder of The Food Safety Leadership Group. He outlines the timeline and conditions for compliance and ways to proactively reshape your supply chain and document management processes to align with the FDA's future requirements.