New health regulations make data integrity the foundation of food safety
In 2011, US President Barack Obama signed the US Food Safety Modernization Act, the first major US food safety legislation since 1938. Compass spoke with Daniel R. Matlis, president of Axendia, a food and drug industry analyst firm, about how and why the US Food and Drug Administration (FDA) is depending on food industry data to achieve the legislation’s goal – safe food supplies – and how food companies worldwide will be affected.
COMPASS: What are the goals of the US Food Safety Modernization Act (FSMA)? And are regulatory agencies in other parts of the world moving in the same direction?
Daniel R. Matlis: The FSMA shifts the FDA’s food safety focus from a reactive process – someone gets sick from food and the government tries to figure out why – to preventing contaminated and unsafe food products from ever being released to the public. The law also applies to all food imported into the United States, so non-US food producers also must ensure compliance.
What may surprise you is that the FDA is not simply counting on physical inspections of food processors and producers to achieve the law’s goals. Instead, the FDA is using the data collected by every producer, transporter and processor as food moves through the supply chain to identify and eliminate sources of contamination.
The deadlines for implementation have passed for all but the smallest farms. So what steps have food companies taken to meet these new data-collection requirements?
DRM: Unfortunately, most companies continue to focus on compliance and record-keeping as an operating expense, so they’re using more people, more time, more spreadsheets and more paper in an effort to meet these requirements. In reality, this drives real costs up and productivity down. Even worse, it does little to identify the gaps and address the risks that the legislation was intended to eliminate, so our food chain may not be significantly safer than before.
How should companies be responding?
DRM: Sound data is the foundation to good decisions and good science. Product quality, safety and efficacy all rely upon the vast amounts of data generated throughout the product lifecycle.
However, to give the FDA the visibility it needs, manual methods simply can’t report relevant data with enough detail and context. What results is an incomplete picture of the risks and hazards, which leads to unrecognized vulnerabilities and uninformed decision-making.
The FDA has cited companies for a long list of data integrity problems: lack of raw data to support records; inaccurate and incomplete records; test results for one batch being used to release other batches; backdating; fabricating data; and discarding data. All of these issues are inherent in manual, paper-based reporting because those methods lack security and don’t maintain the data history.
Do companies need to invest in more computer systems?
DRM: No, more systems are not the answer. The real challenge is to manage data across multiple systems that were never designed to work together, which is why people have to run around and collect the reporting data manually.
What companies need instead is a platform that ensures data integrity from beginning to end. It’s the only way to achieve digital continuity and integrity and make compliance reporting simple, informative and actionable.
Why is a platform necessary to digital continuity?
DRM: A platform approach unifies data, applications, processes and people across the organization, as well as with external partners. Data-consuming applications from business, manufacturing, laboratory and quality areas all draw data from an authoritative source. This allows users across the value chain to access, organize, analyze and share scientific, quality and process data with full confidence of their integrity. Digital continuity enabled by a platform makes data available while ensuring that it is unaltered, complete, useful and in context.
How can companies justify the cost of a platform for regulatory compliance?
DRM: The silver lining in all of this is that platform-enabled data integrity and consistency don’t just help with regulatory compliance. In fact, they are the key to ensuring overall quality, accelerating innovation, shortening product development cycles and increasing the rate of new product introductions.
A fully integrated platform enables collaboration, decision-making and innovation by supporting visibility across research, design, quality, manufacturing and post-market. While you may not want to invest in a platform just to support compliance, you can certainly justify investing in one to grow and improve your business.
So you expect to see more companies make the transition?
DRM: If they want to survive they don’t have a choice about whether – only when. Standalone solutions have created disconnected data islands that hinder visibility, quality and compliance, increase costs and make it difficult or impossible to make data-driven decisions. It’s time to view the entire business as an integrated system with the overarching goal of improving quality and safety.
Companies that do this will win in the marketplace because they will have earned the trust of both regulators and consumers by supporting safe food supplies.
Daniel R. Matlis is founder and president of Axendia, an analyst firm that advises industry executives and regulators on business, technology and regulatory issues across the health science value chain.
Matlis began his career at Johnson & Johnson, where he specialized in technology and regulatory compliance. He also was a partner, VP and GM with a leading life sciences consulting firm before founding Axendia. He holds a bachelor’s degree in electrical engineering from Polytechnic University (NYU School of Engineering) and a master’s degree in management from the New Jersey Institute of Technology.