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Sophisticated data handling, traceability, and monitoring techniques are required throughout the research and development process to ensure that food developers provide products that are safe, free of contaminants, and meet data integrity and regulatory compliance requirements. The process of adapting existing recipes to create variations that meet consumer tastes and dietary requirements consists of several components, including: 1) leveraging historical formulations and recipe data and 2) accurately capturing and interpreting data from the iterative development and associating it with the new ingredient and, ultimately, the new product.
Many organizations have moved to a paperless research process, implementing food-centric electronic laboratory notebooks (ELNs) with embedded, flexible recipe management capabilities. In doing such, food ELNs offer the best of both worlds, capturing both context of the experiment and the structured data of the formulation. Advanced food ELNs provide a platform to automate structured data capture, leading to reduced human error; facilitate data exchange with third-party systems (PLM [product lifecycle management], LIMS, etc.); and document the iterative development of the recipe. These ELNs can also make the parent-child relationship fully traceable to meet FDA data-retrieval guidelines, all resulting in increased safety, responsibility, and visibility.
A food ELN platform is not solely focused on the recipe design. The functions and capabilities can be leveraged across new product development, analytical, sensory, QC, package research, and other business areas, leading to streamlined collaboration, a source of truth, and a means for increased searchability across the product lifecycle. Food ELNs are a full complement to any traditional PLM system, showcasing 100% of the research process, who did what and when—integrating all laboratories and research facilities across the organization.
Improved recipe design results in better recipe management, while tracking the genealogy (i.e., a batch within a batch) of all ingredients and every experimental iteration of every recipe. Understanding the context of each failed attempt is as important as the success. In addition, an effective data management platform can accelerate product commercialization.
Beyond improving data traceability and searchability, advanced data management solutions enable organizations to ensure regulatory compliance by integrating regulations into GxP regimes. The FDA’s Food Safety Modernization Act (FSMA) emphasizes the importance of preventing food safety problems, rather than reacting to problems after they occur, by improving the rates of compliance with prevention and risk-based food safety standards.1 This high level of food safety applies to imported and domestic ingredients, and is another benefit of tracking data within management solution systems. A clear record of a new ingredient’s genealogy and its effect on the end product during research helps strengthen an organization’s safety measures.
Independent from the FDA’s oversight, the FSMA requires an obligation from organizations collaborating with external third parties to verify that their suppliers are meeting FDA food safety measures. FSMA is also contemplating a role for reliable, third-party audits conducted by a government or private agency.2 The FDA’s commitment to ensuring food safety may evolve into leveraging third-party audits as part of its overall compliance strategy. Although audits are not required, establishing a framework that involves multiple layers of protection, authentication, and documentation may become the future of food research and safety. This move to more stringent compliance regulations would require more documentation from food and beverage organizations, and those that have already adopted data management systems that complement this certification process would have a strategic advantage. By improving internal research data mining, organizations are preparing for future regulations.
Accurate recording of research data and the ability to quickly search historical data and track the genealogy of products result in products being developed more rapidly and consistently while ensuring consumer safety and regulatory compliance.
References
- https://www.fda.gov/Food/GuidanceRegulation/FSMA/default.htm
- https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm543296.htm
Jeff Tishler is solutions consultant, and Kevin Arnold is senior account manager, Global Strategic Accounts, IDBS, 2 Occam Ct., Surrey Research Park, Guildford, Surrey GU2 7QB, U.K.; tel.: +44 1483 595 000; e-mail: [email protected]; www.idbs.com