June 2023 - rfxcel.com

Antares Vision Group Becomes the First DSCSA Compliance Software Awarded a Spot on the GSA MAS Contract with Lovell Government Services

Antares Vision Group Becomes the First DSCSA Compliance Software Awarded a Spot on the GSA MAS Contract with Lovell Government Services

The distinction is a result of a partnership between AV Group subsidiary rfxcel and service-disabled veteran-owned small business (SDVOSB) Lovell Government Services that aims to protect patients served by government entities.

Travagliato (Brescia), June 28, 2023. Antares Vision Group, through rfxcel, a leading provider of supply chain traceability and compliance solutions, has been awarded a spot on the General Services Administration (GSA) Multiple Award Schedule (MAS) contract. With partner Lovell Government Services, a service-disabled veteran-owned small business (SDVOSB), this significant achievement demonstrates the companies’ commitment to federal and state government entities that operate pharmacies and the patients they serve.

Through its partnership with Lovell, rfxcel is the first Drug Supply Chain Security Act (DSCSA) compliance software provider to be awarded a spot on the GSA MAS contract, a procurement vehicle for government agencies to purchase goods and services from pre-approved vendors. The contract includes pre-negotiated terms and conditions that simplify the procurement process.

The DSCSA is designed to improve the safety and security of the drug supply chain in the United States by rapidly detecting and removing harmful drugs. It requires manufacturers, distributors, dispensers (i.e., pharmacies and health systems), and other entities to track, trace, and verify certain medicines as they are received and dispensed.

rfxcel’s DSCSA solution for government dispensers is already in use by the Ohio Department of Veterans Affairs. Lovell is a contracted vendor for many government agencies, including the Department of Veterans Affairs, the Defense Logistics Agency, and the Department of Defense.

“Listing on the GSA MAS contract through Lovell is a win-win for everyone,” said rfxcel Vice President of Government Services Greg Moulthrop. “First, it protects patients who use government pharmacies. But it also enables government agencies to easily and efficiently purchase our DSCSA compliance software solutions and gives government customers the dual benefit of complying with the DSCSA while working toward their SDVOSB procurement goals.”

“We are excited to be partnering with Antares Vision Group, through rfxcel, on this important initiative,” said Chris Lovell, CEO of Lovell Government Services. “rfxcel has made it their mission to help federal pharmacies meet DSCSA compliance requirements by November 2023 and Lovell is honored to play a part in it. DSCSA isn’t just about protecting the supply chain, it is also about protecting patients.”

For more information, contact rfxcel Senior Government Affairs Advisor Kevin Smith at ksmith@rfxcel.com or 563-590-9408.

About Antares Vision Group & rfxcel

Antares Vision Group, through rfxcel, is a leading provider of supply chain traceability and compliance solutions. The company’s mission is to deliver value to its customers through a comprehensive suite of software solutions that ensure supply chain integrity, visibility, and regulatory compliance. rfxcel’s solutions have been used by leading companies in industries such as pharmaceuticals, food and beverage, and consumer goods. Learn more here.

About Lovell Government Services

Lovell Government Services is a trusted government vendor since 2013 with a proven track record of success. Lovell is a two-time Inc. 5000 honoree and leader in the federal space. They partner with medical and pharmaceutical companies looking to better serve veteran and military patient populations, increase their federal revenue stream, and win government contracts. Click here to learn more.

Antares Vision Group & Result Group Digitalize Millions of Unique Game Pieces for Enhanced Consumer Engagement and Traceability Across Australia

Antares Vision Group & Result Group Digitalize Millions of Unique Game Pieces for Enhanced Consumer Engagement and Traceability Across Australia

The partners are deploying AV Group’s DIAMIND solution to manage fast food leader Hungry Jack’s UNO™ campaign, one of the most advanced intelligent packaging initiatives in the Australian market.

Travagliato (Brescia), June 14, 2023 – Antares Vision Group, the technology partner for digitalization of products and supply chains and a leading provider of traceability and inspection  systems, has partnered with Result Group to manage Hungry Jack’s UNO™ campaign in Australia. Utilizing AV Group’s DIAMIND solution, they are managing millions of game pieces with unique digital identities and enhancing consumer engagement with the popular game.

Founded in 1971, Hungry Jack’s is the master Australian franchise of the Burger King Corporation and one of the country’s largest fast food chains, with more than 440 restaurants. It has over 19,000 employees and serves 1.7 million people every week. Its successful UNO™ campaign began in 2021 and is now in its third iteration.

This is Antares Vision Group’s first collaboration with Melbourne-based Result Group, which supplies innovative equipment and materials that help Australian businesses improve efficiency in their manufacturing and distribution processes. Result Group has manufactured the game pieces for every Hungry Jack’s UNO™ campaign.

AV Group’s DIAMIND solution generates and manages the unique digital identity for every game piece. It integrates with the digital printing of these “micro labels” and their application on food packaging, then commissions each to confirm its validity. When a customer redeems a game piece through Hungry Jack’s app, website, or in-store at the point of sale, DIAMIND confirms that it is legitimate, decommissions the digital ID, and integrates with prize fulfillment systems to complete the customer experience.

Result Group produces the game pieces, which look and feel like actual UNO™ cards, with conventional flexographic and digital printing presses plus a specialized converting system to bring the pieces together. The latter uses digital technology that enables mass customization, such as altering text and graphics without stopping or slowing down the printing process.

Simon Jones, Antares Vision Group’s Business Development Director, said, “Making Hungry Jack’s UNO™ campaign a success is a triumph of interoperability, integrating all the back-end systems, the front-end applications, and providing secure data management for every game piece and redemption event. But beyond the technology, it was about people and partnership, with the Result Group and AV Group teams working tightly with Hungry Jack’s and its service providers to really deliver on this.”

“What our partnership is doing for Hungry Jack’s is a great showcase for interoperability and showing the world about getting platforms to talk and share information with each other,” said Michael Doss or, Group General Manager at Result Group. “It’s paramount to the whole traceability story. Every one of those 17 million UNO™ game pieces is being tracked individually right through the supply chain. AV Group’s DIAMIND Enterprise solution is enabling expanded possibilities, enhanced interaction with customers through interoperability, and has improved the game overall.”

 

ABOUT ANTARES VISION GROUP

Antares Vision Group is driving digitalization of products and supply chains by leading traceability, inspection, and integrated data management. AV Group helps companies and institutions to achieve safety, quality, efficiency, and sustainability, enabling Trustparency™. DIAMIND, AV Group’s integrated ecosystem of solutions, simplifies the technology environment and supports businesses growth by enabling a data-driven and tailored journey to digital innovation. Connecting physical products with digital identities, DIAMIND runs at the line, factory, warehouse, enterprise, and supply chain levels, and guarantees product quality (inspection systems and equipment) and end-to-end traceability (from raw materials to production, from distribution to the consumer and back) through integrated data management, applying artificial intelligence and potentially blockchain. AV Group operates in the Life Science (pharmaceuticals, medical devices, and hospitals), Beverage, Food, Cosmetics, Chemicals, and Packaging industries and potentially many others. AV Group has been listed in STAR segment of Euronext since 14 May 2021 and has been included in the Euronext Tech Leaders index, dedicated to leading tech companies with high growth potential, since July 2022. In 2022, Antares Vision Group recorded a turnover of €223 million. The Group operates in 60 countries, employs more than 1,100 people, and has a consolidated network of over 40 international partners. For further information, visit www.antaresvisiongroup.com 

 

For further information:

Raffaella Mora | PR Specialist Antares Vision Group: raffaella.mora@partner.antaresvision.com

Garrison Spik | Senior Communications & Content Manager, Antares Vision Group Supply Chain Visibility: garrison@rfxcel.com

 

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

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:

  1. 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.
  2. Designate foods for which additional recordkeeping requirements are appropriate and necessary to protect the public health.
  3. 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

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.