TraceGains’ mission is to promote quality and safety within the food supply chain by offering process automation solutions to mitigate risk, improve quality, and empower 365 Audit Ready™ companies. TraceGains provides a SaaS-based supplier, quality, and regulatory document management solution to food, ingredient, beverage, and packaging companies, helping you achieve and maintain compliance with the Food Safety Modernization ACT (FSMA), Global Food Safety Initiative (GFSI), and Hazard Analysis and Critical Control Points (HACCP) requirements, without needing to add additional staff. Each TraceGains product can work independently as a standalone solution, or side-by-side with legacy quality management systems (QMS), enterprise resource planning (ERP), product life-cycle management (PLM), or laboratory information management systems (LIMS).

Soterian Systems, LLC

Soterian Systems, LLC is an innovative food safety and quality management technical advising firm that provides clients with industry leading tools and training specifically designed to successfully build and maintain world class Food Safety Management Systems.  They offer public and private training classes for accredited IHA HACCP and FSMA Preventive Controls Qualified Individual (PCQI), and FSVP. They develop and implement continuous improvements with GFSI and FSMA food safety programs, including physical plant upgrades, equipment compliance and plant hygienic zoning fulfilling industry best practices, code, and regulatory requirements. They provide a robust selection of template packages and audit tools for GFSI schemes and FSMA Food Safety Plans and supporting documents. Soterian also assists clients with microbial challenge studies to validate unique food safety potential hazards within the facility and/or equipment.

With 25 years of global industry experience with growing operations, high risk USDA and FDA processing, distribution and QSRs, they assist clients to create a culture of food safety and quality. Projects led by Soterian Systems can be fully customized to fit the client’s needs, making the process work for any size company.

Marc C. Sanchez, CIHCC, LLC

Marc Sanchez represents FDA-regulated companies in the food, dietary supplement, beverage, cosmetic, medical device and drug industries. With a focus on international trade, he advises clients on the regulatory requirements and strategic corporate considerations that affect the importation, distribution and exportation of FDA regulated products. Marc is a frequent national speaker on FDA compliance issues affecting the food, dietary supplement, and medical device industries. He is also considered a leading voice in understanding the Food Safety Modernization Act, which has fundamentally changed food law in the U.S.