Food & Beverage Safety Risk Mitigation: Navigating FDA Traceability & 21 CFR Part 11

The US Food and Beverage (F&B) market grew from $1.8 trillion in 2023 to a projected $1.88 trillion in 2024, reflecting a compound annual growth rate of 4.5%. As food companies scale their operations, they also introduce new technologies and diversify supply chains, increasing their exposure to changing regulatory requirements.

Under 21 CFR Part 11, the Food and Drug Administration (FDA) regulates the validity of electronic data provided by F&B companies. The FDA also recently updated its safety standards and traceability mandates.

Traceability is becoming increasingly important with more consumers becoming health-conscious about their food choices. There is a growing call for food manufacturers to trace the sources of their product ingredients.

Food companies need to have well-maintained records, such as ingredient sourcing details and production logs, that are integral to regulatory standards. Those who fail to do so are also vulnerable to reputational damage.

That’s why the F&B sector needs a clear strategy to mitigate these risks. But first, let’s understand why risk mitigation is vital in the current scenario.

The Cost of Non-Compliance: Analyzing 2024 Food Recall Trends

According to a report by the Public Interest Research Group (PIRG), there was an 8% year-on-year increase in food and beverage recalls and alerts in the US in 2024. About 300 food products were recalled and linked to 13 outbreaks. Of these, nearly all involved Listeria, Salmonella, or E. coli.

The following recalls made headlines:

• A Minneapolis-based food supplier recalled fresh-cut and processed cantaloupe that was sold to distributors across several states due to suspected Listeria contamination.
• An ice cream company recalled a variant after mistakenly packaging it in a carton that did not declare serious allergens, such as almond, walnut, and pecan—all of which could be life-threatening upon consumption.
• A Jacksonville-based frozen seafood company recalled raw shrimp that tested positive for Cesium-137, a radioactive isotope that is commonly found in nuclear reactors and weapons.
• A more serious recall in recent times was from a California-based dairy manufacturer, which caused a multi-state listeriosis outbreak that was traced back to its manufacturing facilities. Following a federal investigation, the manufacturer recalled its entire line of nearly 120 dairy products and halted operations in October 2024.

These are just a few examples that point to the varied nature of the risks, whether chemical, allergenic, or related to labeling errors, involved in food production. When proper traceability processes are missing or not prioritized, these food issues can quickly stall operations.

The food and beverage industry has also undergone scrutiny in recent years, especially with the FDA implementing the Food Traceability Rule in 2022. This regulation allows the FDA to identify and remove hazardous or contaminated food from the market. It requires manufacturers to maintain and provide records that contain Key Data Elements (KDEs), such as storage temperatures, batch numbers, and harvest dates.

Mastering 21 CFR Part 11: Compliance for Digital Food Records

More F&B companies are becoming increasingly digital in their processes. As a result, it is crucial to validate the authenticity of food compliance records, such as supplier certifications and temperature monitoring logs. For this, the FDA has devised 21 CFR Part 11, a compliance framework for the food and beverage sector to follow. Initially developed for the pharma industry, this framework was set up to validate the legality and reliability of electronic records provided by manufacturers during compliance checks. These requirements include:

• Keeping clear audit trails, including data and record changes, and time-stamped logs during the production process
• Validating systems to ensure that all electronic systems perform the necessary functions
• Allowing only authorized personnel, such as supervisors and floor managers, to have access to sensitive data, including production batch records and ingredient lists.
• Maintaining authentic electronic signatures with the use of unique and verifiable identifiers
• Ensuring adequate staff training so that only skilled and qualified personnel handle food production systems
• Retaining every digital record and keeping it secure and accessible as per compliance timeframes

Failing to adhere to this framework can expose your company to multiple risks, including legal penalties and loss of consumer trust.

Financial & Reputational Risks of Poor Food Traceability

If you have yet to develop a risk mitigation strategy, your food company may face these major consequences:

 Heavy financial losses: Proactively tracing ingredients and adhering to standardized practices during food production can help reduce the risk of recall, which can cost companies an average of $10 million, in addition to the loss of future sales.

Legal penalties: Non-compliance issues, such as misrepresentation of food claims, food contamination, or incorrect labeling, can incur heavy fines. For example, in 2020, a major Mexican food chain was ordered to pay a staggering $25 million fine for its role in foodborne illnesses that affected more than 1,000 people. While these fines may seem insignificant to major food corporations, they can gravely affect the operations of small and midsize food companies.

Operational disruptions: Aside from financial and legal consequences, food recalls and investigations can disrupt entire operations. For instance, they may halt food production or create issues in supply chain partnerships and pipelines.

Impaired reputation: Even a single failure in compliance can put your company’s reputation at stake, especially in a social media-dominated world where news spreads fast.

Building a Modern Traceability System to Prevent Costly Recalls

Contamination and mislabeling issues are common in food production. However, a company’s commitment to traceability can make a huge difference. Companies that adopt strong traceability systems are more adept at removing the affected products before they reach food distributors.

Such systems rely on accurate and reliable data that helps companies identify sources of contamination quickly, thereby eliminating the need for damaging product recalls later on. A well-maintained trail also helps companies adhere to regulatory standards and keep consumers safe. In contrast, incomplete or corrupted electronic records can quickly dilute a company’s defense against regulatory action.

How Alpha Software Automates Your Food Safety & Compliance

Companies can reduce the risk of non-compliance by having a risk mitigation partner that can help them develop a strategy in the face of an evolving F&B landscape. In case of an FDA audit or a compliance deadline, this strategy can help you build a defense against human errors, production blind spots, and disparate systems.

Alpha Software understands the regulatory intricacies that keep food manufacturing executives up at night and helps develop solutions with traceability and data integrity in mind. We can assist food and beverage companies build risk mitigation software that:

• Automates the traceability process from farm to fork, so that you can track every step in the supply chain and production process. This makes you ready for action when a compliance issue, such as contamination or labeling error, arises.
• Helps you build audit trails that track changes or deviations in production automatically. This means you have tamper-proof records ready for use, which eliminates the need to retrace your steps during regulatory inspections.
• Replaces obsolete paper logs with compliant and secure digital records with verified signatures as per the Part 11 framework.
• Helps you create a personalized risk dashboard for a live glimpse into your biggest potential compliance risks, from allergen labeling to supplier certifications. This allows you to act fast before matters escalate and affect the public.
• Creates an atmosphere of continuous improvement, even when staff changes or regulations evolve. The result? Your team is always up-to-date with the latest compliance measures.

Alpha Software helps keep your food production and supplier data compliant, so you can continue to grow without the threat of regulatory risks.