Food Manufacturers Struggle With Documentation Burden as Compliance Complexity Outpaces Manual Systems

A mid-sized manufacturer using fifty ingredients across twenty products manages roughly 5,000 pages of primary compliance documentation. These documents expire on staggered schedules: certificates of analysis every 90 days, while certifications such as organic, kosher, and halal require annual renewal. When any document updates, changes must cascade through every affected formulation, label, and customer specification.

“While on balance, I believe today's food system is impressive when you think about the wide variety of foods available to many consumers for a fraction of their hard-earned dollars, I do believe today's food system has one major Achilles heel: a lack of traceability and transparency,” said Frank Yiannas, former FDA Deputy Commissioner for Food Policy and Response, addressing the International Association for Food Protection in July 2019.

Yiannas has repeatedly emphasized the importance of documentation and traceability. In 2022 remarks to the World Health Organization, he noted that “Traceability is a priority under both FSMA and the New Era of Smarter Food Safety… While people often think that food traceability is simply a reactive tool, nothing could be further from the truth.”

Beyond FSMA, manufacturers face a growing web of overlapping requirements:

National Bioengineered Food Disclosure Standard
Genetic modification documentation

FDA Nutrition Innovation Strategy
Updated labeling

State regulations such as California’s Proposition 65
Chemical exposure disclosures

Customer certifications
Organic, non-GMO, gluten-free, kosher, and halal

This expansion collides with increasingly globalized supply chains. Manufacturers now source ingredients from more suppliers across more regions than ever before, multiplying documentation requirements and creating exponential compliance overhead.

The Institute of Food Technologists 2023 Employment and Salary Survey reports median salaries of $85,000 for QA managers and over $100,000 for senior regulatory affairs professionals. Even well-staffed teams struggle to maintain awareness of thousands of document expirations while managing day-to-day operations.

Technology providers are stepping in with cloud-based platforms that centralize document management and automate compliance tracking. These range from basic repositories to advanced systems capable of understanding relationships between ingredients, formulations, and regulations.

When implemented effectively, such platforms:

Reduce document retrieval from hours to seconds
Cut audit preparation time from weeks to days
Provide automated expiration alerts and compliance validation

Early adopters are already seeing results. One beverage manufacturer reported a 75 percent reduction in audit preparation time, while a specialty foods producer avoided three potential recalls by catching expiring certificates in time.

Still, adoption is uneven. Smaller manufacturers often lack resources, and larger organizations face resistance to process change. Mid-sized companies are caught between recognizing the need and struggling with execution.

Contract manufacturers manage documentation for their own operations and for multiple brand clients, each with distinct specifications. A single facility might need organic certification for one brand and kosher compliance for another.

Traditional separate documentation systems create redundancy and risk. Modern unified platforms are designed to maintain separation by client while eliminating duplication. Some platforms are even matching brands with manufacturers based on certification compatibility, accelerating the search for production partners.

This efficiency directly impacts competitiveness. Manufacturers with robust, organized documentation systems can respond to new opportunities faster and more confidently.

The FDA reports that the average food recall costs ten million dollars in direct expenses, not including brand damage and lost sales. There were 167 food recalls in fiscal year 2023. While not all stem from documentation failures, inadequate recordkeeping often worsens both frequency and severity.

Modern compliance infrastructure investments range widely:

Small manufacturers: fifty thousand to one hundred thousand dollars
Large multi-facility organizations: millions for integrated platforms

Industry observers note that digital compliance will likely follow the trajectory of ERP adoption in the 1990s, first a competitive edge, then a market requirement.

The FDA’s New Era of Smarter Food Safety initiative explicitly supports technology adoption for compliance and traceability. Combined with customer demand for electronic documentation, the trend is clear: digital compliance is becoming essential infrastructure.

Emerging technologies will accelerate this transformation:

AI for predicting compliance risks
Blockchain for verification across supply chains
NLP for monitoring regulatory changes and mapping impacts

Yet technology alone is insufficient. Successful transformation requires standardized processes, staff readiness, and cultural trust in automation. Companies must balance ambition with practicality.

The food industry’s documentation burden will only grow. Organizations that modernize will gain resilience and efficiency. Those that persist with manual systems risk falling behind or facing costly failures when a single expired certificate triggers a recall.

Transformation will not happen overnight, but in an industry where one missing document can cost millions, the greater risk lies in doing nothing.

Mark Haas is the CEO of RegulateCPG with 35 years of experience in food and beverage product development and regulatory compliance.