Leveraging AI to Enable a Single Source of Truth for Pharma and Food Supply Chains

In a recent development that underscores the importance of regulatory compliance, a leading generic pharmaceutical manufacturer was fined $1.5 million for distributing adulterated drugs. In addition to this, they are also settling for civil liabilities under the False Claims Act, amounting to $2 million. This incident clearly demonstrates why pharmaceutical and food companies must adhere strictly to safety standards and government regulations. The implications are significant, and the fallout from non-compliance can be severe — reputational damage always adds sting beyond the monetary penalties. 

However, in the pharmaceutical and food industries, compliance is not merely a regulatory obligation — it’s a commitment to safety, quality, and consumer trust. From the perspective of industry stakeholders, including manufacturers, regulators, and consumers, compliance is critical to business operations. It impacts product quality, public health, and brand reputation. That’s why these industries devote so much time to compliance. A Pharma IQ survey reveals that nearly 50% of participating pharma professionals spend more than 40% of their time dealing with regulatory issues.

Given the strict and ever-growing regulation of the pharmaceutical industry, compliance is not only here to stay. Still, it will likely be refined and reinforced in the coming years, requiring heavier budgets and more sophisticated structures. The same holds for the food industry, where ensuring quality and compliance is essential to safeguarding consumer health. By leveraging integrated data platforms, AI-assisted record verification, and other AI-driven preventive measures, pharma and food companies can achieve a single source of truth across the entire supply chain, from manufacturing to end use. While there are numerous benefits to this level of visibility, the most important is simply preventing substandard products from reaching the market.     

Roadblocks to Efficient Compliance

No one should underestimate the challenges of building best-in-class, data-driven regulatory compliance capabilities. In the pharmaceutical and food industries, the most complex compliance challenges will be found in the following areas:

• Data integration. Integrating data from diverse sources — such as ERP systems, shop floor data, sensors, and IoT devices — poses significant challenges. These systems generate vast amounts of information, each with its format and structure. Harmonizing this data requires robust infrastructure and standardized protocols. Gaps or inconsistencies may occur without seamless integration, affecting compliance and traceability.
• Accuracy of records. Maintaining accurate records throughout the manufacturing process is essential. Errors, omissions, and data losses can lead to non-compliance with regulatory requirements. Manual record-keeping, while common, is prone to mistakes. Automated solutions, such as digital record systems and AI-assisted verification, are crucial for ensuring data accuracy and reliability.
• Multifaceted variables. The food and pharmaceutical industries face a unique compliance challenge: Often, they must measure compliance to variable parameters like temperature not just at the point of manufacturing but also throughout the logistics journey. As a result, emerging manufacturing and supply chain technologies developed for other industries may need to be significantly adapted to meet the needs of food and pharmaceutical suppliers.  

Leveraging AI for Compliance

Artificial intelligence (AI) will soon play a crucial role in ensuring compliance across the pharmaceutical and food sectors.

Implementing integrated data platforms allows seamless data flow across systems. Manufacturers gain real-time insights into production processes by integrating data from various sources — such as ERP systems, shop floor data, sensors, and IoT devices. Advanced IoT sensors, for example, can provide precise information on environmental conditions, equipment performance, and product quality — data points that will serve regulatory compliance efforts today and far into the future. IoT will prove critical for many vaccine manufacturers, allowing them to validate that their significant investments in cold-chain technology deliver precise temperature control during storage and distribution. Other sub-sectors will have varying levels of technological advancement, and their interconnected systems can be adapted to enhance compliance by enabling efficient data exchange and accurate monitoring.

Assisted record verification is another promising intervention. By deploying machine learning algorithms to analyze data and detect anomalies, it ensures data integrity and reduces the risk of human error. This automation enhances the ability to maintain accurate and reliable documentation, ensuring compliance with regulatory standards. Automated preventive measures — such as computerized checks during production, packaging, and distribution — further minimize risks and prevent non-compliant products from entering the market. AI-driven compliance ensures adherence to regulations and enhances overall business agility and operational excellence by reducing the risk of supply chain disruptions.

Furthermore, AI-driven compliance measures have impressive side benefits: They can improve data consistency, streamline operations, accelerate product time-to-market, and provide a centralized source of data for scaling operations.

A Secure Foundation for Pharma and Food

As regulations evolve, pharmaceutical and food companies must embrace AI-driven solutions — such as integrated data platforms and AI-assisted record verification — to navigate challenges and ensure compliance. Leaders in these industries fully recognize their responsibility to safeguard public health, maintain accurate records, and prevent non-compliant products from entering the market. Increasingly, AI will allow them to push those imperatives even further.

About the Authors

Sumeet Suri 
Consulting Partner, Manufacturing and Supply Chain

For more than 20 years, Sumeet has focused on leveraging emerging technologies to transform pharmaceutical, healthcare, and medical device supply chains. Working with organizations such as Daiichi Sankyo, Haleon, Viatris, and GSK, he has created robust and resilient global supply chains with end to end visibility, advanced supply chain re-modelling, led regulatory approvals for pharmaceutical plants and clinical trial facilities, and enabled the launch and distribution of more than 1,500 pharmaceutical SKUs for global markets.

Gaurica Chacko
Vice President and Global Life Sciences Industry Leader

Gaurica is a proven industry leader with more than 20 years of experience in management consulting and the health sector, with a focus on business and digital transformation, cloud development, health equity, and product strategy. Gaurica works at the intersection of business and technology and specializes in connecting with clients and partners to find innovative solutions to complex business problems. Gaurica has been a key contributor in the areas of digital inclusion, health-tech innovation, and public-private partnerships, and serves as an executive member of the World Economic Forum-Edison Alliance. She has been listed as one of the Top 50 Innovators in AI for 2023 by Intelligent Health AI. Gaurica has a passion for bringing innovative therapies and diagnostics to underserved patient populations and is driving global cross-stakeholder initiatives to leverage AI for social good.