Taking a step further in prioritizing technology and data modernization efforts, today the FDA announced the launch of a new Office of Digital Transformation. The office realigns the agency’s information technology, data management and cybersecurity roles into a central office that reports directly to the FDA commissioner. The reorganization will also help FDA further streamline its data and IT management processes, reducing duplication of processes, and promote best practices, technological efficiencies and shared services in a strategic and secure way.
“Good data management, built into all of our work, ultimately helps us meet and advance the FDA’s mission to ensure safe and effective products for American families,” said Acting FDA Commissioner Janet Woodcock, M.D., in an FDA news release. “The agency began these efforts because, as a science-based agency that manages massive amounts of data to generate important decisions and information for the public, innovation is at the heart of what we do. By prioritizing data and information stewardship throughout all of our operations, the American public is better assured of the safety of the nation’s food, drugs, medical devices and other products that the FDA regulates in this complex world. This reorganization strengthens our commitment to protecting and promoting public health by improving our regulatory processes with a solid data foundation built in at every level.”
Recent food scandals around the world have generated strong public concerns about the safety of the foods being consumed. Severe threats to food safety exist at all stages of the supply chain in the form of physical, chemical and biological contaminants. The current pandemic has escalated the public’s concern about cross contamination between people and food products and packaging. To eliminate food risks, manufacturers need robust technologies that allow for reliable monitoring of key contaminants, while also facilitating compliance with the ISO 17025 standard to prove the technical competence of food testing laboratories.
Without effective data and process management, manufacturers risk erroneous information, compromised product quality and regulatory noncompliance. In this article, we discuss how implementing a LIMS platform enables food manufacturers to meet regulatory requirements and ensure consumer confidence in their products.
Safeguarding Food Quality to Meet Industry Standards
Food testing laboratories are continually updated about foodborne illnesses making headlines. In addition to bacterial contamination in perishable foods and ingredient adulteration for economic gains, chemical contamination is also on the rise due to increased pesticide use. Whether it is Salmonella-contaminated peanut butter or undeclared horsemeat inside beef, each food-related scandal is a strong reminder of the importance of safeguarding food quality.
Food safety requires both preventive activities as well as food quality testing against set quality standards. Establishing standardized systems that address both food safety and quality makes it easier for manufacturers to comply with regulatory requirements, ultimately ensuring the food is safe for public consumption.
In response to food safety concerns, governing bodies have strengthened regulations. Food manufacturers are now required to ensure bacteria, drug residues and contaminant levels fall within published acceptable limits. In 2017, the ISO 17025 standard was updated to provide a risk-based approach, with an increased focus on information technology, such as the use of software systems and maintaining electronic records.
The FDA issued a notice that by February 2022, food testing, in certain circumstances, must be conducted in compliance with the ISO 17025 standard. This means that laboratories performing food safety testing will need to implement processes and systems to achieve and maintain compliance with the standard, confirming the competence, impartiality and consistent operation of the laboratory.
To meet the ISO 17025 standard, food testing laboratories will need a powerful LIMS platform that integrates into existing workflows and is built to drive and demonstrate compliance.
From Hazard Analysis to Record-Keeping: A Data-Led Approach
Incorporating LIMS into the entire workflow at a food manufacturing facility enables the standardization of processes across its laboratories. Laboratories can seamlessly integrate analytical and quality control workflows. Modern LIMS platforms provide out-of-the-box compliance options to set up food safety and quality control requirements as a preconfigured workflow.
The requirements set by the ISO 17025 standard build upon the critical points for food safety outlined in the Hazard Analysis and Critical Control Points (HACCP) methodology. HACCP, a risk-based safety management procedure, requires food manufacturers to identify, evaluate and address all risks associated with food safety.
The systematic HACCP approach involves seven core principles to control food safety hazards. Each of the following seven principles can be directly addressed using LIMS:
Principle 1. Conduct a hazard analysis: Using current and previous data, food safety risks are thoroughly assessed.
Principle 2. Determine the critical control points (CCPs): Each CCP can be entered into LIMS with contamination grades assigned.
Principle 3. Establish critical limits: Based on each CCP specification, analytical critical limits can be set in LIMS.
Principle 4. Establish monitoring procedures: By defining sampling schedules in LIMS and setting other parameters, such as frequency and data visualization, procedures can be closely monitored.
Principle 5. Establish corrective actions: LIMS identifies and reports incidents to drive corrective action. It also enables traceability of contamination and maintains audit trails to review the process.
Principle 6. Establish verification procedures: LIMS verifies procedures and preventive measures at the defined CCPs.
Principle 7. Establish record-keeping and documentation procedures: All data, processes, instrument reports and user details remain secured in LIMS. This information can never be lost or misplaced.
As food manufacturers enforce the safety standards set by HACCP, the process can generate thousands of data points per day. The collected data is only as useful as the system that manages it. Having LIMS manage the laboratory data automates the flow of quality data and simplifies product release.
How LIMS Enable Clear Compliance and Optimal Control
Modern LIMS platforms are built to comply with ISO 17025. Preconfigured processes include instrument and equipment calibration and maintenance management, traceability, record-keeping, validation and reporting, and enable laboratories to achieve compliance, standardize workflows and streamline data management.
The workflow-based functionality in LIMS allows researchers to map laboratory processes, automate decisions and actions based on set criteria, and reduce user intervention. LIMS validate protocols and maintain traceable data records with a clear audit history to remain compliant. Data workflows in LIMS preserve data integrity and provide records, according to the ALCOA+ principles. This framework ensures the data is Attributable, Legible, Contemporaneous, Original and Accurate (ALCOA) as well as complete, consistent and enduring. While the FDA created ALCOA+ for pharmaceutical drug manufacturers, these same principles can be applied to food manufacturers.
Environmental monitoring and quality control (QC) samples can be managed using LIMS and associated with the final product. To plan environmental monitoring, CCPs can be set up in the LIMS for specific locations, such as plants, rooms and laboratories, and the related samples can then be added to the test schedule. Each sample entering the LIMS is associated with the CCP test limits defined in the specification.
Near real-time data visualization and reporting tools can simplify hazard analysis. Managers can display information in different formats to monitor critical points in a process, flag unexpected or out-of-trend numbers, and immediately take corrective action to mitigate the error, meeting the requirements of Principles 4 and 5 of HACCP. LIMS dashboards can be optimized by product and facility to provide visibility into the complete process.
Rules that control sampling procedures are preconfigured in the LIMS along with specific testing rules based on the supplier. If a process is trending out of control, the system will notify laboratory personnel before the product fails specification. If required, incidents can be raised in the LIMS software to track the investigation of the issue while key performance indicators are used to track the overall laboratory performance.
Tasks that were once performed manually, such as maintaining staff training records or equipment calibration schedules, can now be managed directly in LIMS. Using LIMS, analysts can manage instrument maintenance down to its individual component parts. System alerts also ensure timely recalibration and regular servicing to maintain compliance without system downtime or unplanned interruptions. The system can prevent users from executing tests without the proper training records or if the instrument is due for calibration or maintenance work. Operators can approve and sign documents electronically, maintaining a permanent record, according to Principle 7 of HACCP.
LIMS allow seamless collaboration between teams spread across different locations. For instance, users from any facility or even internationally can securely use system dashboards and generate reports. When final testing is complete, Certificates of Analysis (CoAs) can be autogenerated with final results and showing that the product met specifications. All activities in the system are tracked and stored in the audit trail.
With features designed to address the HACCP principles and meet the ISO 17025 compliance requirements, modern LIMS enable manufacturers to optimize workflows and maintain traceability from individual batches of raw materials all the way through to the finished product.
To maintain the highest food quality and safeguard consumer health, laboratories need reliable data management systems. By complying with the ISO 17025 standard before the upcoming mandate by the FDA, food testing laboratories can ensure data integrity and effective process management. LIMS platforms provide laboratories with integrated workflows, automated procedures and electronic record-keeping, making the whole process more efficient and productive.
With even the slightest oversight, food manufacturers not only risk product recalls and lost revenue, but also losing the consumers’ trust. By upholding data integrity, LIMS play an important role in ensuring food safety and quality.
Ensuring the safety and authenticity of food is a key responsibility of growers, producers, manufacturers and suppliers. With so many partners involved in the journey from farm to fork, tracking chain of custody data and maintaining a clear, unbroken record are essential to safeguard the quality and provenance of products. However, without proper systems to maintain transparent supply chain audit trails, businesses operating within the food industry run the risk of being responsible for adverse events that could result in health, economic or even legal consequences.
One of the biggest challenges associated with maintaining a clear chain of custody is the need to monitor the flow of raw materials, ingredients and products across increasingly global distribution networks. To successfully track food products throughout the value chain, information on product movements and quality control data must be accessible to those who need it. These systems must also remain compliant with the latest regulations, as well as ensure stakeholders can achieve the highest levels of productivity to meet consumer demand.
For players within the food supply chain to achieve transparent processes and complete traceability, robust information exchange mechanisms and integrated data management systems are key. The latest digital solutions are ensuring the integrity of supply networks by capturing and making available data from any stage of this journey for regulatory or product quality assurance purposes.
Food Safety: A Global Responsibility
The global nature of modern supply networks can make ensuring the safety and quality of food challenging. From honey and juice to yogurt and cheese, tracking the lifecycle of food products is essential to combat food fraud and adulteration, as well as safeguard consumers from harmful food contaminants, such as pesticides and bacteria. Unscrupulous behavior from businesses operating within the supply chain can, for example, cause consumers to purchase products that are not what they claim to be, and even put customers’ health at risk through exposure to potentially unsafe batches.
Given the global expansion of the food supply chain, regulatory bodies are putting increased focus on ensuring that products that pass through multiple channels and regions comply with the same regulations. By focusing on enforcing standards through audits and reviews, it becomes possible to prevent and therefore reduce the potential for adverse events occurring.1 As a result, voluntary standards such as the ISO 22000 guidelines, and mandatory regulations such as FSMA and EU 178/2002, have been put in place to set clear benchmarks for stakeholders’ responsibilities and better enforce food quality and safety.
Regulations such as these require extensive record keeping, transparent audit trails and accountability for all processes. While end-to-end monitoring of one process may be relatively straightforward, ensuring visibility for every process within a complex food supply network can quickly become an overwhelming task. In order to achieve regulatory compliance across all aspects of a supply chain, businesses must be able to integrate their data management systems to achieve full oversight. Moreover, with effective data management tools in place, businesses can organize and incorporate data from all aspects of a food product lifecycle in a compliant manner, enabling them to expand globally.
Integrating Digital Solutions for Better Outcomes
To preserve consumer confidence and brand integrity, businesses operating within the food industry are recognizing the need for automated infrastructures that can manage data, streamline processes, and ensure traceability and accountability for every product. By integrating all monitoring processes into a single system and enabling access to this information via the cloud, the latest digital data management platforms are working to alleviate the challenges associated with operating global supply networks.
Manually organizing inventory management, standard operating procedure (SOP) use, and product traceability can be difficult and time-consuming, especially if operations are on a global scale. Setting up automated processes to manage fail points using a laboratory information management system (LIMS), where they can be itemized and protocols established for potential hazards and preventive measures, can boost speed and efficiency while ensuring the highest levels of data integrity.
Routine food safety testing requires the consistent replenishment of supplies, and the failure to keep on top of inventory use can cause operations to grind to an unexpected stop. Automatic supply level monitoring and automated ordering using a LIMS can eliminate inventory fail points and help to ensure uninterrupted productivity. Furthermore, introducing electronic SOPs as part of a LIMS can define and outline workflows to prevent unintended errors and ensure reliability. Additionally, tracking and logging products using barcode readers throughout their lifecycle gives stakeholders confidence in the products they handle, and can simplify quality control and regulatory review processes.
With the need to monitor so many processes across the food supply chain, there are large volumes of instrument data, workflows and records that must be maintained. Leveraging a LIMS to collect and manage disparate data from all aspects of every process can help stakeholders to streamline workflows. From evaluating potential hazards to eliminating possible issues, having procedures tracked automatically not only transforms processes, but also simplifies quality assessment.
The latest LIMS are able to aggregate all of this data in a single cloud-based system, making this information available at the tap of a tablet or smartphone. Integrating a LIMS with laboratory equipment across food safety testing protocols allows for automated data transfer and increased lab efficiency. Data can be captured from laboratory equipment using a connected scientific data management system (SDMS), which is generated using the approved methods and SOPs available from a laboratory execution system (LES). Interfacing to each instrument using the LES ensures there are no input or copying errors. Subsequently, as process results are entered into the system, any out of specification parameters can be flagged and reported automatically.
The value of an LES within a LIMS can be seen in food safety labs where global demand drives time to market and thus the need for high production efficiency. By giving lab managers control over method and protocol management from any location, the actions of users can be easily recalled for performance monitoring and accountability purposes. And with protocols, regulations and corrective actions defined through the LIMS, labs can achieve faster and more effective decision-making.
Digital solutions such as LIMS are enabling food safety scientists to perform analyses based on readily available SOPs using LES platforms, collect and store data in its original form using an SDMS, and evaluate how the data is being collected, transferred, stored and accessed from a centralized, cloud-based LIMS. These integrated digital solutions offer comprehensive support for the organization of chain of custody data, ensuring full traceability and compliance, and protecting consumer safety and food integrity.
Improved Traceability for Regulatory Compliance
Current regulations are enforcing the quality and safety of food products using well-defined standards for laboratory processes, ensuring the transparency of data handling processes, from raw materials to packaged products. ISO 22000 sets recommendations for food safety management systems and requires businesses to implement hazard analysis and critical control points (HACCP) to ensure the highest levels of quality control and assurance throughout the product lifecycle.
Regulations such as EU 178/2002 and FSMA include mandatory requirements for the traceability of food, feed and any other food-related substance or animal through identification and food tracking programs. Given the unfortunate growth of food fraud, traceability and authentication are becoming increasingly important. The latest regulations are helping the food industry to maintain optimal production practices to safeguard public health, maintain consumer confidence and preserve brand integrity.
Systems that are fully harmonized with these guidelines can be used to maintain data in organized archives, simplify audit trail recording for proof of compliance, and enable easy-access for users to review data. The latest LIMS can support HACCP compliance by automatically alerting users to deviations in expected processing parameters. In this way, issues can be quickly identified, and corrective action can be taken to prevent potentially dangerous products from reaching the consumer.
Digital lab and data management solutions are helping food supply chain stakeholders to simplify tracking, improve transparency and ensure the highest levels of accountability to protect both product authenticity and consumer safety. The integration and implementation of these systems helps to fulfill production demands as well as meet future challenges, allowing the food industry to expand and develop services and checks with the growing global market. Moreover, the potential for food fraud or adulteration is greatly minimized, giving consumers additional confidence in the products they purchase.
Charlebois, S. Sterling, B. Haratifar, S. and Naing, S.K. (2014). “Comparison of Global Food Traceability Regulations and Requirements,” Compr. Rev. Food Sci. Food Saf., vol. 13, no. 5, pp. 1104–1123.
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