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FDA Postpones Enforcement of Key DSCSA Requirements to November 27, 2024

Posted on August 28, 2023November 10, 2023 by rfxadmin

In a guidance document published on Friday, August 25, the U.S. Food and Drug Administration (FDA) announced that it was delaying by one year enforcement of key requirements under the Drug Supply Chain Security Act (DSCSA). This “extended stabilization period” moves the enforcement date to November 27, 2024.

The guidance is primarily for manufacturers, wholesale distributors, dispensers, and repackagers; delayed enforcement pertains to product identifiers at the package level; saleable returns; interoperable, electronic product tracing; and investigating suspect and illegitimate products. We provide the specifics below.

The key takeaway: Don’t stop preparing for the DSCSA requirements. If you have questions about the DSCSA delay or are concerned that your current provider may not have the tools you need to comply, we encourage you to contact us today to speak with one of our DSCSA experts. We are committed to meeting DSCSA compliance for all our customers in a timely manner.

And if you’re going to the Healthcare Distribution Alliance (HDA) 2023 Traceability Seminar in Washington, D.C., stop by Table-Top 21 to meet our team and talk about the developments in person. Click here to learn more.

Overall FDA rationale for the DSCSA delay

The FDA said extending enforcement will give supply chain stakeholders — particularly manufacturers, wholesale distributors, dispensers, and repackagers — the extra time that may be necessary “to continue to develop and refine appropriate systems and processes to conduct interoperable, electronic tracing at the package level, to achieve robust supply chain security under the DSCSA while helping ensure continued patient access to prescription drugs.”

Furthermore, the Agency said, “additional time beyond November 27, 2023, may be needed for systems to stabilize and be fully interoperable for accurate, secure, and timely electronic data exchange.”

What DSCSA requirements are affected?

Product identifiers

The requirement. Trading partners must include the product identifier at the package level for each package in a transaction into the transaction information. Furthermore, a product’s manufacturer or repackager must incorporate the PI at the package level for each package “introduced in a transaction into commerce.” These requirements are included in section 582(g)(1)(B) of the Food, Drug, and Cosmetics Act (FD&C Act).

Reasoning for DSCSA delay. The FDA said the delay will “accommodate the additional time (beyond November 27, 2023) that may be needed by trading partners to achieve compliance and to help ensure continued access to prescription drugs as trading partners continue to refine processes” to include the PI at the package level. Furthermore, the FDA said “this policy will facilitate the use and exhaustion of product supply already in the supply chain prior to November 27, 2024.”

What is a PI? The PI is a standardized graphic that contains, in both human-readable form and on a machine-readable data carrier, four data elements:

1. 1. National Drug Code (NDC)
  2. Serial number
  3. Lot number
  4. Expiration date

Saleable returns

The requirement. Each person accepting a saleable return must have systems and processes in place to allow acceptance of the product. Furthermore, they may accept saleable returns only if they can associate the product with its transaction information — including the PI — and transaction statement. These requirements are included in section 582(g)(1)(F) of the FD&C Act.

Reasoning for DSCSA delay. FDA said delaying enforcement of this requirement until November 27, 2024, will “facilitate the continued use of methods currently being used by wholesale distributors for associating a saleable return product with its applicable transaction information and transaction statement while accommodating the additional time that may be needed for all trading partners to mature the new systems and processes required for acceptance of saleable returns.”

Interoperable, electronic product tracing at the package level

The requirement. Transaction information and transaction statements must be exchanged in a secure, interoperable, electronic manner. This requirement is included in section 582(g)(1)(C) of the FD&C Act; the standards for exchange are established under section 582(h) of the DSCSA.

Furthermore, systems and processes for verifying products at the package level, including the standardized numerical identifier, must meet the standards established in DSCSA section 582(a)(2) and the guidance in DSCSA section 582(h).

Reasoning for DSCSA delay. The FDA these policies will allow trading partners to continue to provide, capture, and maintain data for the data exchange for product tracing and verification while providing additional time that may be needed to “continue to develop and refine systems and processes for electronic data exchange.”

Investigating suspect and illegitimate products

The requirement. In the even of a recall or to help investigate a suspect or illegitimate product, stakeholders must be able to promptly provide product transaction information and transaction statement when requested by the FDA secretary or other appropriate federal or state official. This requirement is included in section 582(g)(1)(D) of the FD&C Act.

Furthermore, Section 582(g)(1)(E) of the FD&C Act requires stakeholders to “produce the transaction information for each transaction going back to the manufacturer” in certain situations, including a recall or investigating a suspect product or an illegitimate product.

Reasoning for DSCSA delay. FDA believes these compliance policies will facilitate the continued use of methods currently being used by trading partners to respond to the type of requests for information described above while accommodating the additional time that may be needed for trading partners to mature the new systems and processes required for such activities under section 582(g)(1)(D) and (E) of the FD&C Act.

FSMA Rules: A Guide to FDA Food Safety Modernization Act Regulations

Posted on August 7, 2023October 12, 2023 by rfxadmin

The Food Safety Modernization Act (FSMA) is transforming the food supply chain in the United States. Learn about FSMA requirements and how they affect the food industry.

Understanding the FDA Food Safety Modernization Act (FSMA)

The Food Safety Modernization Act (FSMA), signed into law in 2011, aims to reduce foodborne illness, protect the U.S. food supply, and ensure public health. The law gives the U.S. Food and Drug Administration (FDA) authority to regulate the production, processing, packing, and transport of food throughout the country.

The FDA has finalized nine major rules through FSMA that address different aspects of the food supply chain. FSMA covers both human and animal food, and the rules are designed to address issues such as traceability, sanitation, produce safety, and supplier verification.

7 FSMA rules and requirements

Through FSMA, the FDA has issued rules that govern food production and distribution. The food traceability final rule established additional traceability recordkeeping requirements for persons who manufacture, process, pack, or hold foods included on the Food Traceability List (FTL). Additionally, there are seven main roles that the FDA implemented in the final FSMA rules.

- 1. Preventive Controls for Human and Animal Food: Require food facilities to meet Current Good Manufacturing Practice (CGMP) requirements, conduct hazard analyses, and establish risk-based preventive controls.
  2. Produce Safety Rule: Established science-based standards for the production, packing, and storage of fruits and vegetables on farms in the U.S. and other countries.
  3. Foreign Supplier Verification Program (FSVP): Requires foreign suppliers to show that they are meeting food safety standards required in the U.S.
  4. Sanitary Transportation Rule: Established regulations for the sanitary transportation of human and animal food.
  5. Accredited Third-Party Certification Rule: Created a program to accredit specific third-party certification bodies to conduct food safety system audits of foreign facilities.
  6. Protection Against Intentional Adulteration: Aims to address the probability of an outbreak due to potential food safety risks of intentional adulteration.
  7. Voluntary Qualified Importer Program (VQIP): fee-based program provided by the FDA FSMA to foreign food facilities that intend to import their products into the country.

Other rules concern protection against intentional adulteration of food and guidelines for the use of agricultural water.

Compliance strategies for FSMA

Navigating FSMA can be complicated, especially as rules are proposed, reviewed, and finalized. To implement effective compliance strategies, organizations should:

- - Review: Start by conducting a thorough review of FSMA requirements to understand which rules apply to your business.
  - Develop: Create a robust FSMA food safety plan that’s tailored to your operations, including hazard analysis and critical control points (HACCP).
  - Implement: Establish preventive controls and monitoring systems across the organization and have a plan in place for food recalls.
  - Verify: Use audits and validation procedures to ensure compliance.

Implementing FSMA’s Preventive Controls and Hazard Analysis

FSMA’s Preventive Controls for Human Food, finalized in 2015, was created to minimize and prevent hazards at food facilities. Key components of this rule include:

- - Current Good Manufacturing Practice (CGMP) revisions: FSMA updated FDA’s existing CGMP requirements to create binding requirements for employee education and training.
  - Food safety plans: The rule created new requirements for risk-based preventive controls and hazard analysis at food facilities, including sanitation practices and allergen controls.

Businesses covered under the Preventive Controls rule must perform a hazard analysis of their facilities and products, implement food safety practices, and provide ongoing monitoring and verification of all preventive controls.

Ensuring FSMA compliance in supply chain management

Even if you’re confident about your organization’s food safety practices, you need to know that your supply chain partners are holding themselves to the same standards. Establishing clear supplier approval and verification processes can help you thoroughly vet the growers, suppliers, processors, or distributors you work with.

By implementing traceability and documentation requirements, you’ll be able to track specific products and lots in real-time. As with your internal processes, conduct regular assessments to ensure suppliers and co-manufacturers are maintaining FSMA compliance.

Final thoughts: FSMA rules and regulations

The worldwide food industry should monitor events in the United States as FSMA traceability requirements evolve. It’s not just about compliance and being able to sell products in America; it’s about being able to anticipate regulatory trends, keeping your supply chain moving at peak performance, and leading in the industry through adaptation and innovation. It’s also about leveraging the FSMA regulations to create business opportunities.

We understand the importance of complying with FSMA and other regulations for the food and beverage industry. We have extensive experience delivering tailored traceability, visibility, and transparency solutions that not only help ensure compliance, but also create added value for operational efficiency, brand protection, and customer loyalty. Contact us today and one of our traceability experts will show you how it works.

And be sure to download our “Traceability in the Food Supply Chain” white paper, which explains the FSMA Food Traceability List and the Food Traceability Final Rule in detail.

The Importance of Food Traceability: Impacts on Safety and Business

Posted on August 7, 2023 by rfxadmin

As food traceability regulations continue to evolve, it can be difficult to navigate requirements and ensure you remain compliant everywhere you do business. Find out more about the traceability of food products in this guide from Antares Vision Group and rfxcel.

Understanding food traceability

In broad terms, traceability is the process of utilizing data to know the history of everything in your supply chain — every input and ingredient, every finished product. Traceability empowers you to know where something came from, where it has been, and where it is right now. It’s the ability to find granular details about the past and present of an item.

No matter your role in the supply chain, food traceability can play a vital role in securing and improving your business, from ensuring you comply with regulations to helping manage risks (e.g., making recalls faster and more accurate) and connecting with consumers.

Benefits of food traceability

The advantages of a strong food traceability system for you, your partners, and your customers include:

- - Food safety: Traceability reduces the risk of foodborne illnesses and helps ensure your products are safe for consumption.
  - Risk mitigation: If a food safety issue does arise, traceability facilitates prompt, informed responses. For example, traceability speeds food recalls and targeted product withdrawals to minimize the impact on public health and lessen interruptions to your operations.
  - Operational efficiency: Food traceability solutions act across your supply chain to improve operations and make it easier to manage your inventory.
  - Trust: Food traceability can help build consumer trust and confidence through transparent processes and demonstrating that you are a reliable brand whose products are exactly what you say they are.

Key elements of food traceability

The primary components of a good food traceability system include:

- - Identification: Companies must be able to trace individual products and raw materials back to specific locations, batches, lots, etc.
  - Product tracing: Each product must be traceable from farm to fork, with granular documentation that captures its journey at every stage of the supply chain.
  - Data capture and management: A strong, centralized system is needed for collecting, analyzing, sharing, and storing traceability records.
  - Authentication: Verification tools ensure the accuracy and integrity of food traceability data and can help resolve errors before they affect other parts of the supply chain.

Implementing food traceability systems

Here are some things to consider if you want to implement a new food traceability solution or improve your existing systems:

- - Evaluate: Start by assessing traceability requirements and regulatory obligations. Examine what industry leaders are doing to identify best practices and opportunities.
  - Select tools: Choose the appropriate traceability technologies and systems for the type of products you grow, pack, process, distribute, etc. (Working with a reliable, experienced solution provider is essential.)
  - Implement processes: Establish your traceability protocols and standard operating procedures, training relevant staff. (Again, make sure you’re working with a solution provider that will work with you and your team to ensure implementation is quick and efficient.)
  - Collaborate: Work with partners and stakeholders to implement traceability measures across the supply chain.

Food traceability in action: U.S. FDA Food Safety Modernization Act

Passed in 2011, the Food Safety Modernization Act (FSMA) made sweeping reforms to food safety regulations in the United States. The legislation empowered the U.S. Food and Drug Administration (FDA) to create and enforce rules on how food is harvested, processed, stored, and distributed throughout the United States.

FSMA’s No. 1 goal is to reduce the rates of illness from foodborne pathogens; food traceability is an important component of the FDA’s strategy to achieve that goal. The Agency’s primary guidance for traceability is the Food Traceability Final Rule, which went into effect in November 2022. It establishes additional traceability recordkeeping requirements for businesses that manufacture, process, pack, or hold foods on the Food Traceability List (FTL).

These food supply chain stakeholders are responsible for establishing and maintaining critical tracking events (CTEs) and associated key data elements (KDEs) for events such as harvesting, cooling, packing, and receiving. CTEs and KDEs are the building blocks of food traceability under FSMA. Read our food traceability white paper to learn how they work.

What food products are required to be traced under FSMA?

FSMA’s Food Traceability Final Rule sets the recordkeeping requirements for any business that manufactures, processes, packs, or holds foods on the Food Traceability List, which includes almost 20 types of food, such as:

Fresh fruits and vegetables
Leafy greens
Melons
Nut butters
Finfish
Crustaceans
Soft cheeses
Ready-to-eat deli salads

Final thoughts: food traceability

Traceability is essential to ensure the safety, transparency, and quality of the global food supply chain. Our goal is to equip businesses with modern food traceability solutions that improve operational efficiencies, comply with regulations, foster consumer confidence, and help create a more secure and transparent food industry. Offering end-to-end traceability, visibility, and transparency, our solutions for the food and beverage industry make it easy to track and trace products across every step of the supply chain. Contact us today to speak with one of our traceability experts and see a short demo of how our solutions work.

The Ultimate Guide to Supply Chain Visibility: Enhancing Efficiency and Performance

Posted on July 7, 2023August 4, 2023 by rfxadmin

The ability to monitor each part of your supply chain helps your business mitigate risk, serve customers better, and work more efficiently. Find out more about the importance of supply chain visibility in this guide from Antares Vision Group and rfxcel.

Understanding Supply Chain Visibility

Modern business operations require a high level of coordination and logistics. A company may source raw materials from one location, have a manufacturing facility in another location, and deliver products to customers all over the world. To produce, package, and ship goods efficiently, they need a centralized tracking system.

Supply chain visibility traces a product from its raw materials and through the manufacturing process to the point at which it reaches a customer’s doorstep. A visibility solution allows a business to track all its goods through every step in the supply chain. Supply chain visibility can:

Increase efficiency
Ensure customer satisfaction
Inform decision-making
Improve sustainability

Ultimately, visibility – or lack thereof – affects your bottom line.

Benefits of Supply Chain Visibility

To stay competitive in today’s globalized economy, businesses need efficient systems for monitoring supply and demand. Supply chain visibility benefits include:

Tracking: Real-time tracking and traceability tools streamline inventory management, offering automation for many routine tasks.
Efficiency: Visibility tools enhance the accuracy of demand forecasting and reduce the likelihood of stockouts.
Risk management: Full visibility means that teams can respond more quickly when there is a supply chain disruption, mitigating the risk and minimizing delays.
Optimization and better collaboration: Supply chain management systems help companies communicate better with suppliers, optimizing relationships and fostering collaboration.

Key Components of Supply Chain Visibility

Although supply chain visibility systems may differ from company to company, they all focus on transparency at each node of the supply chain. This includes:

Inventory visibility: Companies can track and manage inventory levels and procurement across all their locations.
Transportation visibility: All products in transit can be tracked and monitored in real time.
Demand visibility: Robust supply chain network data allows businesses to understand customer patterns and forecast demand more accurately.
Supplier visibility: Real-time visibility tools allow you to monitor supplier performance and ensure timely deliveries.
Data visibility: By collecting information about inventory, transportation times, and more, companies can turn data analytics into actionable insights and adjust workflows or supply chain processes.

Implementing Supply Chain Visibility

Putting supply chain visibility tools into place takes time and effort, but it’s well worth the benefits you’ll reap in operational efficiency and better business performance. To implement supply chain visibility, start by assessing your current systems. Look for areas of improvement across the supply chain – have you experienced stockouts in a particular product line? Do you struggle to meet customer demand at a certain time of year?

Next, look for the right technology solutions that can enhance visibility across your entire ecosystem. Perhaps you have a good system in place for monitoring customer orders but need a better way to manage suppliers. Look for supply chain software that can integrate with your existing systems and address gaps in visibility.

You need a seamless flow of information across your technology platforms. Additionally, prioritize data security in any supply chain visibility initiative. Compliance with data privacy regulations is a must for your company, as well as any suppliers, shippers, or distributors you work with.

Best Practices for Supply Chain Visibility

Whether you work in pharmaceuticals or food and beverage, certain practices will improve visibility across the entire supply chain. These include:

Metrics: Have a clear set of goals and metrics in place that you will use to measure your success.
Collaboration: Build strong partnerships with suppliers to enhance transparency and efficiency.
Technology: Invest in cloud-based platforms and advanced analytics tools with built-in supply chain security.

Above all, adopt a proactive approach to risk management and contingency planning. While some supply chain disruptions are out of your control, having a plan in place will make it easier to minimize inefficiencies and shortages.

Overcoming Challenges in Supply Chain Visibility

Even with the best-laid plans, you may face roadblocks when trying to improve end-to-end supply chain visibility. Potential challenges include:

Supply chain data quality issues and data silos
Resistance to change and organizational barriers
Regulatory compliance and data privacy concerns

Managing a significant volume of data, especially when you are working in the context of a complex global supply chain with multiple partners and stakeholders, can feel overwhelming. That’s why it’s so important to find supply chain visibility software that integrates with all your data collection systems. You should look for a software service provider that is well-versed in regulatory compliance and has built-in data protections.

Understand that even when you choose an intuitive, user-friendly system, you’re likely to face pushback from some employees or partners. Plan a thoughtful implementation and roll-out process, with time built in for staff training. This will help address any concerns.

The Future of Supply Chain Visibility

Emerging technologies and digital transformation are changing the supply chain management landscape. Already, we’re seeing the value of artificial intelligence (AI) and machine learning in supply chain software solutions. AI-powered tools can analyze real-time data to inform forecasting, using predictive analytics to inform orders, pricing, warehouse placement, and more.

The Internet of Things (IoT) and blockchain technology are also shaping supply chain visibility. By giving all supply chain stakeholders access to the same information, blockchain tools can potentially reduce fraud and data errors while improving communication. And the proliferation of IoT devices means that real-time tracking is easier throughout order processing and delivery.

We’ll Help You Achieve Supply Chain Visibility

We offer supply chain visibility solutions that prioritize efficiency and compliance management. With offices in the United States and abroad, we serve clients in sectors including:

Pharmaceuticals
Food
Beverage
Consumer goods
Government

For information on our supply chain visibility tools or to request pricing, contact us today.

The Power of Supply Chain Visibility Tools: Revolutionizing Efficiency and Transparency

Posted on July 7, 2023August 4, 2023 by rfxadmin

Today’s businesses work all over the world. Companies need sophisticated tools to track and monitor products as they move through the supply chain. Learn more about supply chain visibility tools and solutions in this guide from Antares Vision Group and rfxcel.

Understanding Supply Chain Visibility Tools

At its core, supply chain visibility is the ability to track raw materials, individual parts, and finished products, regardless of where they are located or what phase of production they are in. Visibility and connectivity are critical in modern supply chain management, as suppliers and distributors can be located in different regions or even different countries. Businesses use supply chain planning software to monitor orders in transit, reduce lead times, and send notifications to stakeholders.

Supply chain traceability systems help companies monitor each step of product manufacturing and shipping. These tools can identify weaknesses or communication breakdowns, plan for inventory shortages and procurement needs, and resolve minor issues before they become bigger supply chain disruptions. Plus, these tools improve accountability and transparency throughout a business, including with partners. Ultimately, the goal of using these tools is to optimize operational efficiency and supply chain performance.

Benefits of Supply Chain Visibility Tools

Implementing supply chain traceability software offers many benefits:

Monitor products: Companies have access to real-time tracking and monitoring of their inventory, orders, and shipments.
Traceability: Individual products and shipments can be traced from start to finish, helping to ensure orders arrive on time.
Efficiency: With real-time visibility tools, supply chain managers can improve demand forecasting, allow for better inventory management, and minimize inefficiencies.
Better business relationships: Companies can enhance their collaboration and communication with suppliers and other providers over the long term.
Risk management: With visibility tools, companies can identify supply chain issues and address them head-on, lowering their risk profile and improving their relationships with consumers and service providers.

Key Features of Supply Chain Visibility Software and Tools

Most supply chain management tools have a few key features in common. These include:

Real-time supply chain visibility: Shipments can be geolocated and monitored at each stage of supply chain processes, allowing for tracking and tracing in real time.
Inventory visibility: Companies can monitor and manage inventory levels at each business location through user-friendly dashboards.
Data analytics and reporting: Visibility software collects and analyzes data to provide actionable, real-time insights and streamline supply chain operations. This can help improve order management and planning for replenishment as needed.
Collaboration and communication: Visibility tools make it easier for employees across the supply chain to communicate with each other and with trading partners and other stakeholders. This helps break down departmental silos.

Implementing Supply Chain Visibility Solutions

With so many different ways to approach supply chain visibility, it can be difficult to know where to start. Be intentional in your implementation process to reduce pushback:

Assess: Start by evaluating your supply chain requirements and current pain points. What’s working well, and what isn’t?
Evaluate: Create a list of functionality requirements for your supply chain visibility software. Compare available tools against your set of needs to select the right supply chain visibility tool for your business.
Implement: Integrate the tool you choose with your existing systems and data sources so you’re not reinventing the wheel.
Train: Set aside ample time for onboarding employees who will be using the new system.

Best Practices for Utilizing Supply Chain Visibility Tools

When it comes to global supply chain visibility platforms, there’s no one-size-fits-all solution. Whether you choose a cloud-based SaaS application or an on-premise platform, there are a few best practices that can make the implementation process smoother:

Define clear objectives and metrics for measuring success at your organization.
Establish standardized data formats and processes across the entire supply chain.
Encourage collaboration and information sharing among all logistics service partners and other third parties.
Continuously monitor your tracking processes to improve data quality and workflows.

Ensuring Data Security and Privacy in Supply Chain Visibility

Although sharing real-time data with outside partners and shippers can improve supply chain efficiency and optimization, it also carries a degree of inherent risk. Ensuring data security and protecting your privacy, as well as that of your customers, is paramount.

Look for visibility software that offers high-level, customizable security settings. You should implement secure data-sharing protocols and access controls across all supplier, manufacturer, and distributor partnerships. Any third party that your business works with must know how to comply with the relevant data protection regulations for your sector, such as the European Union’s General Data Protection Regulation (GDPR).

The Future of End-to-End Supply Chain Visibility Tools

As artificial intelligence (AI) and Internet of Things (IoT) technology improve, companies will have even more granular control over the supply chain ecosystem and can incorporate automation. Predictive analytics and machine learning have the potential to help with proactive decision-making to improve demand planning and reduce transportation management challenges. Additionally, as more and more industries adopt blockchain technology, companies will be better equipped to minimize fraud and waste.

Find the Best Supply Chain Visibility Software

To stay competitive in today’s dynamic market landscape, businesses need customizable, sophisticated enterprise resource planning (ERP) tools that drive efficiency and improve customer satisfaction. Antares Vision Group provides tailored solutions to improve supply chain management, prioritizing efficiency without sacrificing quality.

Our software offers end-to-end visibility, providing traceability at each step with an eye toward sustainability. We even offer blockchain -based supply chain traceability solutions. Our solutions work with pharmaceutical, food, beverage, and consumer goods companies all over the world. For more information about our supply chain visibility platform, contact rfxcel today.

Compliance Management Solutions: Ensuring Regulatory Compliance and Risk Mitigation

Posted on July 7, 2023August 4, 2023 by rfxadmin

Does your business have effective compliance management solutions and risk management solutions in place? In a constantly changing regulatory landscape, companies need sophisticated tools to manage their governance, risk, and compliance (GRC) efforts and reduce their risk exposure. Learn about compliance management implementation and best practices in this guide from rfxcel.

Understanding Compliance Management Solutions

Compliance management refers to the set of policies and procedures that an organization uses to ensure adherence to the laws and regulations that govern their industry. Compliance management solutions aim to:

Identify and prevent violations
Improve business practices
Build and maintain consumer confidence
Ensure ethical behavior in the industry

Compliance requirements vary by sector and country. For example, in the United States pharmaceutical companies must adhere to the Drug Supply Chain Security Act (DSCSA) and in the European Union they’re bound by the Falsified Medicines Directive (EU FMD). Food companies in the United States must comply with rules under the Food Safety Modernization Act (FSMA).

Regulatory compliance is a requirement, not a goal. Businesses that are found to be out of compliance can face harsh consequences, including corporate sanctions and government-issued fines. Plus, they run the risk of damaging their reputation and losing customers. Non-compliance can also result in costly corrective actions, such as recalling a product.

Many companies now rely on software solutions to manage and centralize their compliance efforts. Compliance software offers tracking and audit tools to ensure business practices align with applicable laws and regulations. This helps reduce manual errors and provides ongoing monitoring throughout the organization.

Benefits of Compliance Management Solutions

In addition to ensuring adherence to industry regulations and standards, effective compliance management solutions offer a range of benefits, including:

Reduced risk: Effective management processes minimize the legal and financial risks associated with non-compliance.
Efficiency: Compliance management software can streamline routine tasks and reduce manual processes, freeing up staff to focus on other priorities.
Security: A good compliance solution will also have safeguards in place to protect data privacy and improve cybersecurity.
Cost savings: A risk and compliance solution can flag risks before they cause financial implications.

Key Features of Compliance Management Solutions

If your business is in the market for a new compliance management platform, look for a solution that includes these features:

Compliance tracking and monitoring: Your software should manage a centralized repository of the relevant regulations and requirements for your industry.
Policy management: Compliance management solutions can help teams develop, update, and communicate standardized policies across your organization.
Risk assessment and mitigation: Proactive identification and management of compliance risks can help companies avoid fines, fees, and sanctions.
Data insights: Companies can review compliance activities in real time and generate compliance reports that aid in decision-making.
Audit management: A centralized platform streamlines the audit process and can track corrective actions.
Awareness: Compliance management tools help you manage ongoing employee training and awareness programs.

Implementing Compliance Management Solutions

Proper implementation is key when introducing compliance management software solutions. Start with a comprehensive needs assessment: What are your organizational priorities? Which regulatory requirements apply to your business? Use the findings from your assessment to guide your software selection process. Look for a compliance management platform that:

Integrates with your existing software systems and data sources
Can be customized to align with specific regulatory requirements
Has a good user experience and is easy to navigate

Ideally, the software platform you choose should automate compliance processes to reduce administrative burden, saving your organization time and money.

Best Practices for Effective Compliance Management

Utilize these best practices at your enterprise to make your compliance program more effective:

Organizational culture: Establish a culture of compliance. Plan for ongoing training to keep compliance requirements top-of-mind for staff.
Internal audits: Conduct regular compliance assessments and gap analyses to identify areas for improvement.
Coordination: Build a cross-functional compliance team to provide comprehensive oversight that includes stakeholders from HR, legal, and finance departments.
Workflow management: Implement automated workflows and utilize notifications to ensure the timely completion of required compliance tasks.

Ensuring Data Security and Privacy Compliance

An important aspect of compliance management is addressing data protection regulations, which dictate how companies in a wide range of industries (e.g., healthcare and financial services) handle consumer data and personally identifiable information (PII). Data protection regulations include laws such as:

EU General Data Protection Regulation (GDPR)
California Consumer Privacy Act (CCPA)
S. Health Insurance Portability and Accountability Act (HIPAA)

Companies must implement data access controls, encryption measures, and other protections to reduce the likelihood of a data breach. Additionally, if you work with third-party vendors, you need a system for setting up data-sharing agreements. Any third parties with which you contract must comply with your industry’s regulatory requirements and have adequate privacy and security protections in place.

The Future of Compliance Management Solutions

As more and more companies embrace digital transformation and implement distributed or hybrid work structures, compliance needs will continue to shift along with an evolving regulatory landscape. Additionally, newer developments in artificial intelligence (AI) and machine learning will make automated compliance monitoring more sophisticated. AI technology is already improving predictive analytics, which draws on historical data to identify patterns and make predictions that guide future business decisions.

Choose Us for Expert Compliance Management

By leveraging effective compliance management solutions, businesses can streamline their compliance processes, mitigate risks, and maintain regulatory adherence. With us, you can implement a robust compliance management system to navigate regulatory changes and help your organization work more effectively. We offer complete compliance solutions, with software that’s designed to meet the needs of specific industries including:

To get started or request pricing, contact us today.

Food Safety Modernization Act (FSMA): Guidelines, Regulations, and Impact

Posted on June 12, 2023June 12, 2023 by rfxadmin

Passed in 2011, the Food Safety Modernization Act (FSMA) authorized major changes to how the U.S. food supply chain operates. Growers, processors, and food manufacturers are all subject to new regulations intended to prevent foodborne illness and make the food supply safer, traceable, and more transparent. Learn more about FSMA, what it covers, and how it affects food safety compliance in this guide from rfxcel.

Food Regulations and Enforcement in the USA

Before the introduction of the Food Safety and Modernization Act, the Food and Drug Administration (FDA) provided industry guidance on how to reduce food safety hazards. While food businesses could become certified in Good Agricultural Practices (GAP) and Good Handling Practices (GHP), the guidelines offered by FDA were not enforceable.

FSMA expands FDA’s oversight, offering a clear regulatory framework and a set of preventive controls designed to take a proactive approach to food safety.

Importance of Food Safety

A safe and reliable U.S. food supply is critical, both for public health and national food security. According to the Centers for Disease Control and Prevention, foodborne illness affects one in six Americans each year and accounts for 3,000 deaths annually. Investing in food safety measures is important for many reasons. Robust federal support for food safety:

Improves consumer confidence in America’s food supply
Reduces the burden on the U.S. healthcare system by keeping people healthier
Helps detect and contain foodborne illness outbreaks before they spread

What Is the Food Safety Modernization Act (FSMA)?

The Food Safety Modernization Act (FSMA), signed into law in January 2011, authorizes the U.S. Food and Drug Administration (FDA) to take a preventive approach to food safety problems. This new approach gives FDA the authority to establish food safety standards for stakeholders throughout the food and beverage industry supply chain. FSMA amends the Federal Food, Drug, and Cosmetic Act, first passed in 1938.

Why Did the Food and Drug Administration Pass FSMA?

Bacteria, parasites, and other foodborne pathogens make 48 million Americans sick each year. And the nature of today’s global economy means that the food Americans eat could be grown in one state or country, processed in another, then distributed nationwide. By the time an outbreak of E. coli, listeria, or another foodborne disease is identified, hundreds – or even thousands – of consumers could have purchased food that is potentially contaminated.

With FSMA’s new regulations, the goal is to stop these kinds of outbreaks before they happen. Without proper preventive controls, including mandated food traceability requirements, food businesses risk losing valuable time and money dealing with food recalls that can damage their public image.

CDC and FSMA

While FDA is the primary U.S. federal agency tasked with implementing FSMA regulations, the law also provides a directive to the Centers for Disease Control and Prevention (CDC). This agency is tasked with improving the collection, analysis, and reporting of data on foodborne illnesses and outbreaks. CDC must also create and manage Integrated Food Safety Centers of Excellence in partnership with state health departments.

These centers offer technical assistance and training for local health departments, improving their ability to track and trace foodborne disease outbreaks. CDC is also responsible for developing guidelines to manage food allergy and anaphylaxis risks in educational institutions.

When Did FSMA Take Effect?

FSMA was signed into law in January 2011. However, new food safety regulations did not go into effect right away upon passage. Through FSMA, Congress simply authorized FDA to establish food safety requirements for growers, processors, and packers. Implementation of various regulations is ongoing. That means that food businesses must navigate a shifting regulatory landscape as new rules are proposed, finalized, and implemented.

Food Safety Modernization Act Compliance

Under FSMA, FDA has the authority to create and enforce policies through the federal rulemaking process. To date, FDA has finalized nine major rules concerning food production, traceability, transportation, and more. The FSMA guidelines also give FDA new authority to inspect facilities that manufacture, process, or store food for consumption, both in the U.S. and abroad.

The Food Safety Modernization Act Regulations

FSMA’s regulations affect each step of the food chain from field to fork. Per the administrative rulemaking process, federal agencies must publish a proposed rule, then accept and review feedback during a public comment period. The agency may make changes to the final proposed rule based on these comments. Once an agency publishes a final rule in the Federal Register, it typically goes into effect thirty days or more after publication.

FDA’s proposed and final rules and related programs under FSMA include:

Agricultural Water
Accredited Third-Party Certification
Food Traceability
Foreign Supplier Verification Programs (FSVP)
Laboratory Accreditation for Analyses of Foods (LAAF)
Mitigation Strategies to Protect Food Against Intentional Adulteration
Preventive Controls for Human Food
Preventive Controls for Animal Food
Produce Safety
Sanitary Transportation of Human and Animal Food
Voluntary Qualified Importer Program (VQIP)

FSMA Section 204 and the Three Pillars of Traceability

Section 204 of FSMA is entitled “Enhancing Tracking and Tracing of Food and Recordkeeping.” It has three traceability requirements and instructs the FDA to develop additional recordkeeping requirements for certain foods. Quoting verbatim from the Agency’s website, the FDA must:

Establish pilot projects in coordination with the food industry to explore and evaluate methods and appropriate technologies for rapid and effective tracking and tracing of foods.
Designate foods for which additional recordkeeping requirements are appropriate and necessary to protect the public health.
Publish a notice of proposed rulemaking to establish such additional recordkeeping requirements for the designated foods, to help in tracing such foods.

The Food Safety Modernization Act Impact

The passage of FSMA fundamentally changed FDA’s approach to outbreaks of foodborne illness and risk management. Instead of focusing on responding to outbreaks that have already occurred, FSMA prioritizes taking steps to prevent foodborne illness and cross-contamination on farms and food facilities. The legislation means that food businesses are now subject to:

FDA-mandated recalls
Facility inspections
Updated registration requirements

Additionally, FDA guidelines for food safety empower the agency to review facility records and suspend a food facility’s registration if its products are likely contaminated.

How FSMA Affects the Food Industry

FSMA implements new FDA standards for farmers who grow fruits and vegetables. The Produce Safety Rule applies to any grower with average annual produce sales of $25,000 or more. This rule establishes requirements for:

Training for workers who harvest or handle produce
Water quality testing
Preventing contamination from on-farm animals and wildlife
Sanitizing tools and equipment
Recordkeeping

The Produce Safety Rule does not apply to certain fruits and vegetables that are rarely consumed raw, such as beans and potatoes. Furthermore, FSMA does not apply to meat and poultry products, which are regulated by the United States Department of Agriculture (USDA).

How FSMA Affects the Food Supply and Food Facilities

Any food facility that manufactures, processes, packs, or holds food for domestic consumption is required to register with the FDA. This requirement was in place before the passage of the FDA Food Safety Modernization Act. However, FSMA revised this regulation to include:

Mandatory registration renewal every two years
Explicit assurance in the registration documentation that FDA facility inspections are permitted
Additional details on facility activities

The Amendments to Registration of Food Facilities final rule also updated registration requirements to ensure that records are submitted to FDA electronically.

Some of the fresh produce available in U.S. grocery stores year-round is shipped from countries in warmer climates. Recognizing that Americans often consume food that was grown or processed abroad, FDA created a separate final rule on Foreign Supplier Verification Programs (FSVP) that establishes requirements for food producers in other countries. These suppliers must show that their growing, harvesting, or packing practices:

Ensure food is not adulterated
Provide the same level of public health protection as U.S. suppliers
Ensure appropriate labeling for food allergens

These regulations are intended to improve the safety of imported food.

FSMA Preventive Controls and Hazard Analysis

FSMA’s Final Rule for Preventive Controls for Human Food establishes minimum standards for manufacturing, processing, packing, and holding food for human consumption. A separate rule governs the production of animal feed.

Under the preventive controls rule, domestic and foreign food facilities must:

Use Current Good Manufacturing Practices (CGMPs)
Create and implement a written food safety plan that includes a hazard analysis
Train employees on food hygiene and safety practices, from handwashing to sanitizing food prep surfaces

FSMA Compliance and rfxcel

If your business is struggling to implement an effective Food Safety Modernization Act compliance strategy, rfxcel is here to help. Our Traceability System offers a comprehensive, customizable set of solutions to help enact FSMA-compliant preventive controls across all your products and ensure your food safety plan is complete. With rTS, you can:

Record product data at each step of the supply chain
Access real-time data tracing
Audit each pallet, lot, or case of product

Plus, our in-house supply chain experts are well-versed in food safety laws and can provide the technical assistance you need. For more information about compliance management and how we can help you navigate federal food safety regulations, contact rfxcel today.

Compliance Management: Key Challenges and How to Overcome Them

Posted on June 12, 2023August 4, 2023 by rfxadmin

Effective compliance management takes time and effort, but it’s much better to be prepared and prevent problems before they occur. Violating the regulations that govern your industry means you risk losing customers, damaging your reputation, and hurting your bottom line. Fortunately, taking a proactive approach means you can address many of the compliance challenges that companies face. Let’s take a closer look at compliance management systems and their benefits.

What Is Compliance Management?

Companies in any sector must understand and follow the local, state, federal, or international regulations that affect how they do business. Compliance management is the set of tools and procedures that a business uses to ensure they follow the laws that govern its industry. Regulatory requirements may be established by:

Government entities
Labor unions
Trade associations or other industry organizations

For example, pharmaceutical companies have to comply with the U.S. Drug Supply Chain Security Act (DSCSA), whose requirements include product serialization and electronic, interoperable data exchange. Similarly, the U.S. Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA) has specific requirements for traceability and data-sharing.

Why Is Compliance Management Important?

Compliance requirements are often in place to ensure ethical behavior toward customers or competitors. Clear, enforceable regulations set standards for businesses, governments, and civil society organizations.

Failure to adhere to applicable laws or regulations could result in fines, fees, suspension of business operations, revocation of licenses or certifications, or other compliance issues. Thus, many businesses create and establish governance, risk management, and compliance (GRC) programs to minimize their risk.

Three Approaches to Compliance Management

A compliance management solution can vary from simple to complex and must be uniquely tailored to suit an organization’s structure and industry. Three common methods of compliance management are:

Strict, Top-Down Approach

This is the most rigid approach to compliance management. Internal policies are created and implemented by the person or team at the top of the organizational chart. There is no room for flexibility or interpretation. A top-down model is usually needed when the health, safety, and welfare of employees or the people they serve are paramount. For example, a daycare operator must follow all the state and local regulations created to keep minors safe.

Hands-Off Approach

In contrast, a hands-off approach is the most flexible type of compliance management. In this model, leadership may establish compliance standards, but the implementation of day-to-day business processes is handed off to middle managers or other employees.

This approach can work in certain situations. For example, a franchisor that has retail food establishments in different states may be subject to health department inspections in each state. Recognizing that each franchisee is subject to a different set of regulations, they may leave it up to each site manager to implement training or an inspection checklist at their respective franchise.

Shared or Distributed Model

In this approach, compliance activities are shared by employees across the organization. Instead of receiving strict guidelines from a central authority, departments or teams may share the responsibility of creating and implementing compliance activities. Or, the organization may issue a central policy and solicit feedback from employees on what to change or improve. A distributed model can work especially well when companies are implementing newly issued regulations and need feedback from staff on the front lines of their industry.

Compliance Management Challenges

Thoughtful, proactive implementation of compliance measures helps save time and money down the line. But compliance management is not without its challenges, which can include:

Evolving regulatory landscape: Whether you’re a startup or a multinational corporation, keeping up with new and changing regulations can be difficult. In an increasingly complex corporate environment, it makes sense that organizations may struggle to stay up to date.

Changing working environments: In recent years, more and more businesses have embraced a hybrid work model. While letting employees work from anywhere can help organizations stay nimble, it also exposes them to a new set of cybersecurity risks and HR challenges.

Vendor management: You can’t be an expert in everything. Understandably, businesses often partner with third-party vendors for certain services, whether it’s benefits management, IT support, or legal services. Improper vetting or insufficient due diligence can mean that you end up working with vendors that are out of compliance with your industry requirements.

Pharmaceutical, Food and Beverage, and Cosmetics

Companies in the pharmaceutical, food, and beverage, and cosmetics industries face unique challenges when it comes to compliance management. Consumers need to know that the food they eat, the medicine they take, and the personal care products they use are safe.

Pharmaceutical compliance regulations such as the U.S. DSCSA and the EU Falsified Medicines Directive (EU FMD) are in place to improve patient safety, ensure product integrity, and keep counterfeit drugs out of the supply chain. For the food industry, the Food Safety Modernization Act (FSMA) and guidelines like the Global Food Safety Initiative (GFSI), are in place to make the food supply safer and reduce rates of foodborne illness. Regulations for cosmetics vary widely from country to country, but generally, companies must take steps to ensure their products are safe, have complete ingredient labels, and they can verify their labeling claims.

Throughout all these industries, regulatory bodies are increasingly looking to improve supply chain transparency and traceability.

Compliance Management Best Practices

Companies can support regulatory compliance through best practices such as:

Thorough documentation: When in doubt, document everything, even if it’s not mandated by law. A central document repository makes it easy for employees across the organization to find the information they need and prevent non-compliance.

Set data standards: Be sure that you’re meeting the industry standards for high-quality data across all business operations. Inaccurate or incomplete data means you’ll be less prepared for accurate compliance reporting.

Education and engagement: Know your industry inside and out. Staying connected with industry associations, participating in continuing education, and attending events and conferences helps the organization stay up to date on industry changes and trends.

How to Create a Compliance Management Program

Whether you’re implementing compliance management at a new business or overhauling an existing compliance program, these steps are critical:

Conduct a Thorough Risk Assessment

Start by assessing internal and external risks that could affect regulatory compliance. Review each department to identify and document potential issues and to collect qualitative and quantitative data that you can compare against regulatory standards.

Establish Corporate Policies and Procedures

Look to industry guidance to help you create an initial draft of your compliance policy. You’ll likely need input from stakeholders across the organization, including IT, HR, legal, financial, and risk management leaders. If you don’t already have a compliance officer in place, you’ll need to appoint (or hire) one.

Communicate the Plan and Provide Training

Once your organization has a final compliance policy, it must be communicated to all staff and board officers. Set aside time for dedicated training on the policy, how to use a compliance checklist, and how to conduct an internal audit. Make sure all staff is familiar with any regulatory changes or new rules for recordkeeping and reporting.

Account for Routine Maintenance

Schedule regular reviews of your organization’s compliance policy to ensure it reflects changes in your industry or business operations. Budget the resources to help your compliance team stay abreast of changes in the industry and new regulations.

Conduct Periodic Compliance Audits

Routine internal audits can help identify potential issues before they snowball. Plus, periodic audits ensure your company is better prepared to respond to inquiries from government or regulatory bodies. If violations or vulnerabilities are discovered through an internal audit, take remediation steps immediately and review existing policies to see if there’s a way to prevent similar problems in the future.

Compliance Management Solutions

In addition to a set of internal procedures, a compliance management solution should include:

Auditing tools
Ongoing compliance training and education for staff
Board and management oversight

Additionally, workflow tools and apps can help organize compliance processes and automate certain tasks, like data analysis.

Compliance Management Systems

Today, many organizations rely on digital tools to streamline their compliance efforts. A well-designed compliance management system (CMS) can:

Improve data quality and business analytics
Ensure consistency across multiple business locations or branches
Make tracking, traceability, and reporting easier
Automate routine tasks so employees can focus on other business priorities
Minimize an organization’s overall risk exposure

Compliance Management Software

Compliance management software offers a central platform for communicating, overseeing, and documenting compliance activities across an enterprise. We’re committed to improving compliance management through supply chain transparency. With our tailored industry solutions, you can track your supply chain in real-time, no matter where your business is located. rfxcel serves businesses in the pharmaceutical, food and beverage, and consumer goods industries around the world. To learn more about our compliance software solutions or schedule a demo, contact us today.

Spherity and Antares Vision Group further partnership to ensure life sciences customers will comply with upcoming DSCSA regulations

Posted on April 25, 2023November 10, 2023 by rfxadmin

Antares Vision Group, through rfxcel technology, has integrated Spherity’s Credentialing Service into its DSCSA solutions to verify authorized trading partners’ identities and licensing in all regulated interactions.

Reno, Nevada, April 25, 2023 — Spherity, a German leading provider of digital wallet and credentialing solutions, and Antares Vision Group, an Italian multinational and a leading provider of track and trace and quality control systems, are continuing a partnership that helps ensure life sciences customers comply with this year’s U.S. Drug Supply Chain Security Act (DSCSA) regulations.

By November 27, 2023, manufacturers, distributors, dispensers, and other actors in the life sciences supply chain must prove that they are legitimate organizations, or authorized trading partners (ATPs), as defined by the DSCSA.

The two companies first partnered in 2021, when Spherity’s Credentialing Solution, CARO, was integrated into the Group’s Verification Router Service (VRS) solution, enabled by rfxcel technologies, to allow life science customers to confirm their ATPs status. The combined solution also allows customers to exchange DSCSA-compliant electronic Product Identifier (PI) messages, trace products, and create an audit trail of their VRS business interactions.

CARO uses Self-Sovereign Identity (SSI) technology to establish a secure, verifiable digital enterprise identity for every ATP. By integrating the service into its VRS solution, rfxcel customers can ensure secure, authenticated data exchange with other ATPs and verify they have the credentials required by the DSCSA, including state licenses and U.S. Food and Drug Administration Entity Identifiers (FEIs).

“We partnered with Spherity to enable our customers to comply with this year’s DSCSA authorized trading partner (ATP) requirements,” said rfxcel Senior Vice President of Product and Strategy Herb Wong. “With Spherity’s CARO, our VRS solution automatically confirms whether a company is an ATP. Now, every customer can add ATP credentialing to our entire product portfolio and secure their VRS interactions.”

“Spherity will ensure that Antares Vision Group’s customers can securely exchange data with previously unknown entities,” said Georg Jürgens, Spherity’s Manager for Industry Solutions. “The concept of exchanging and verifying credentials using Digital Wallets supports company and product compliance use cases that require communication between regulators, existing supply chain partners, and new trading partners.”

Spherity and Antares Vision Group are members of the Open Credentialing Initiative (OCI), and both contribute to the standardization and industry-wide interoperability of credentialing technology.

For more information about the Spherity-Antares Vision Group partnership, their solutions for DSCSA compliance with ATP requirements, and the Open Credentialing Initiative, contact Spherity’s Manager for Industry Solutions Georg Jürgens at georg.juergens@spherity.com and visit caro.vc, and rfxcel Senior Vice President of Product and Strategy Herb Wong at hwong@rfxcel.com.

ABOUT ANTARES VISION GROUP

Antares Vision Group is an outstanding technology partner in digitalization and innovation for companies and institutions, guaranteeing the safety of products and people, business competitiveness, and environmental protection. The Group provides a unique and comprehensive ecosystem of technologies to guarantee product quality (inspection systems and equipment) and end-to-end product traceability (from raw materials to production, from distribution to the consumer) through integrated data management, applying artificial intelligence and blockchain technology. Antares Vision Group is active in life science (pharmaceutical, biomedical devices and hospitals) and Fast-Moving Consumer Goods (FMCG), including food, beverage, cosmetics, and glass and metal containers. As a world leader in track and trace solutions for pharmaceutical products, the Group provides major global manufacturers (over 50% of the top 20 multinationals) and numerous government authorities with solutions, monitoring their supply chains and validating product authenticity. Listed since April 2019 on the Italian Stock Exchange in the Alternative Investment Market (AIM) segment and from 14 May 2021 in the STAR segment of Euronext; furthermore, from July 2022 included in the Euronext Tech Leaders index, dedicated to leading tech companies with high growth potential. In 2022, Antares Vision Group recorded a turnover of €223.5 million. The Group operates in 60 countries, employs more than 1,100 people, and has a consolidated network of over 40 international partners. To learn more, please visit www.antaresvision.com and www.antaresvisiongroup.com.

ABOUT SPHERITY

Spherity is a German software provider bringing secure and decentralized identity management solutions to enterprises, machines, products, data and even algorithms. Spherity provides the enabling technology to digitalize and automate compliance processes in highly regulated technical sectors. Spherity’s products empower cybersecurity, efficiency and data interoperability among digital value chains. Spherity is certified according to the information security standard ISO 27001.

FSMA 204 Data Carrier Requirements: FDA Guidance & GS1 Standards

Posted on March 23, 2023August 4, 2023 by rfxadmin

We’ve recently talked about Food Safety Modernization Act (FSMA) traceability requirements and GS1 standards and the FSMA traceability lot code. Today, we’re covering FSMA 204 data carrier requirements: FDA guidance and — once again — GS1 standards, including incorporating the mandated traceability lot code into compliant barcodes.

Like our previous post, we’re basing much of this discussion on GS1’s March 1, 2023, industry guidance document, “Application of GS1 System of Standards to Support FSMA 204.” For an in-depth description of GS1 data carriers, check out our “Understanding GS1 Barcodes in the Global Supply Chain” article.

Data carriers: a quick definition for context

A building block for traceability in any supply chain, data carriers enable product information to be quickly and accurately captured, stored, shared, and leveraged for business needs. Companies can mark their entire product hierarchy — from individual items and inner packs to cases/boxes and pallets — with data carriers, which include barcodes (e.g., linear, 2D DataMatrix codes, and QR codes).

Do GS1 barcodes meet FSMA 204 data carrier requirements?

The short answer is “yes.”

However, FSMA does not mandate the use data carriers to provide product information and the FDA does not say what data must be present to meet the FSMA traceability requirements. This is stated clearly in Federal Register Response 524, in which the FDA says that “firms may use product labels to provide the information required [our emphasis] to their supply chain partners if that suits their business practices.”

In the context of this question, suggestions for “product labels” included twist ties, bags, food-grade stickers, and traditional-type labels on produce or customer order forms. For GS1, product labels mean data carriers, primarily barcodes.

What does GS1 say about FSMA 204 data carriers?

In its guidance document, GS1 says this about the FSMA 204 data carrier requirements (or lack thereof):

“Data carriers are not required to meet the requirements of the Final Rule. For this reason, there is no clear prescription of what data must be present in a data carrier to fulfill traceability for the Final Rule. Instead, companies must evaluate what data will enable rapid access to the necessary information in the event the FDA requests their records.”

GS1 explains three types of data carriers that might have applications for the FSMA 204:

1. 1. GS1 Element String (1D and 2D), which can contain the primary identifier (e.g., Global Trade Item Number, or GTIN) and attribute data (e.g., lot/batch number, expiration date, sell-by date, net weight)
  2. GS1 Digital Link URI (2D), a web-compatible format that can contain the primary identifier and attribute data
  3. Electronic Product Code Uniform Resource Identifier (EPC URI), which can contain the primary identifier with a serial number plus attribute data for use in RFID tags, primarily UHF passive tags (also called RAIN RFID).

Using GS1 barcodes as a FSMA 204 data carrier

Below are some examples of how GS1 barcodes might look when used as FSMA 204 data carriers. (We’re not going to get into RAIN RFID today.)

Specifically, we want to illustrate how these barcodes could meet the FSMA traceability lot code requirement, which GS1 says a GTIN + batch/lot numbers would satisfy. (Read our article here for more about the traceability lot code.) In the illustrative images below, we’ve highlighted the GS1 Application Identifiers (AIs) for GTIN (01), lot/batch number (10), and expiration date (17). AIs tell systems what information is being interacted with and enable them to process that information accordingly.

GS1-128. GS1-128 is a 1D barcode that can be up to 6.5 inches long and have up to 48 data characters. In terms of FSMA 204 data carriers, GS1 includes an “important” note that “1D barcodes cannot be removed until all stakeholders expected to scan the barcode are fully capable of interacting with 2D barcodes. This means that both a 1D and 2D barcode would be required during any transition period.”

GS1 DataMatrix. GS1 DataMatrix codes are omnidirectional and support attributes and all GS1 identification keys. They can hold 3,116 numeric or 2,335 alphanumeric characters.

GS1 DataMatrix + GS1 Digital Link URI. The GS1 Digital Link URI essentially turns data carriers into web links. GS1 says that “scanning capabilities are not widely available for GS1 Digital Link URI in general distribution,” so companies would have to update their systems in order to process these barcodes and the data they contain.

GS1 QR Code + GS1 Digital Link URI. Like GS1 DataMatrix codes, GS1 QR codes are omnidirectional and support attributes and all GS1 ID keys; however, they can hold 7,089 numbers or 4,296 alphanumeric characters. Some mobile device cameras cannot process DataMatrix codes, so GS1 says QR Codes are “the current preference for engagement through mobile devices.”

Final thoughts

Let’s repeat what we said in our post about GS1 and FSMA traceability requirements:

One takeaway from today’s article is that the FDA might be telling food companies what the FSMA traceability requirements are, but it’s not telling them how to comply. This is why it’s important to understand GS1’s “take” on the situation and the rationale behind its suggestions.

Food companies are already using GS1 barcodes; adapting them as FSMA 204 data carriers or “product labels” makes good sense. GTINs, batch/lot numbers, Serialized Shipping Container Code (SSCC) data, and other information can be encoded into GS1-128, GS1 DataMatrix, GS1 QR code barcode configurations, as well as Electronic Product Code-enabled RAIN RFID tags and labels.

Contact us today if you’d like to learn more about using a barcode as a FSMA 204 data carrier, how to integrate data capture technology into you FSMA 204 compliance strategy, and everything else you need to have in place by the January 2026 deadline. A short talk with one of our supply chain experts will get you going in the right direction or help you course-correct if you feel like you’ve been treading water with your FSMA initiatives.

And if you’re interested in learning how we’ve put more than 1.5 billion of barcodes on as many products to help a major berry producer control product safety and quality, click here.