US DSCSA Archives - rfxcel.com

EPCIS DSCSA Exceptions Handling: What Is It and Why Is Everyone Talking About It?

Posted on January 4, 2024 by rfxadmin

Just a little over four months into the FDA’s DSCSA extended stabilization period and with the clock ticking down to the November 27, 2024, compliance deadline, EPCIS DSCSA exceptions handling is top-of-mind in the pharma industry.

But why? Let’s take a look at EPCIS DSCSA exceptions handling and how we can deal with it to ensure DSCSA compliance.

EPCIS DSCSA Exceptions Handling Keeps Your Products Flowing

The DSCSA requires the interoperable, electronic exchange of serialized product data. Specifically, trading partners must exchange Transaction Information (TI) and Transaction Statement (TS) data every time a regulated drug changes hands.

Exceptions are errors that may occur when partners exchange this data using EPCIS. If there’s an exception, the product cannot move forward in the supply chain, which means it won’t reach patients and consumers in a timely manner. Furthermore, if exceptions aren’t resolved quickly, a product could be considered suspect or illegitimate.

This is why EPCIS DSCSA exceptions handling is top-of-mind for the pharmaceutical industry.

Given the complex nature of securely exchanging serialized product data, it’s logical to expect exceptions, especially in the early days of enforcement. The Healthcare Distribution Alliance (HDA) has identified six categories of EPCIS DSCSA exceptions:

1. 1. Data Issues
  2. Damaged Products
  3. Product, No Data
  4. Data, No Product
  5. Packaging
  6. Product Hold

Exceptions have been on the HDA’s radar for years. At its Traceability Online Seminar in November 2021, for example, industry leaders discussed establishing standards for dealing with exceptions. They also discussed example scenarios, such as overages as a “Product, No Data” exception. In this scenario, a downstream trading partner might have 16 cases arrive at its facility but receive EPCIS data for only 15 of those cases. How does it notify the manufacturer? How does the manufacturer correct the TI so the case can be removed from quarantine and be on its way?

The message is clear: Trading partners must focus on building a system that quickly communicates and resolves data issues so products can keep moving.

Note: Also remember that the DSCSA requires all partners to be authorized trading partners (ATPs). This isn’t necessarily relevant to our discussion today, but it’s a critical part of compliance.

EPCIS DSCSA Exceptions Handling Solutions: Communication and Collaboration

The most important thing to remember about dealing with exceptions is that trading partners must communicate and collaborate. You are not working in a vacuum, and there is not a “lone wolf” solution for exceptions handling.

Herein lies the challenge. The communication infrastructure in the pharma supply chain — emails, online portals, phone calls, and so on — wasn’t designed with DSCSA compliance in mind, let alone dealing with exceptions handling in an interoperable, electronic data-exchange system.

So, in order for an EPCIS DSCSA exceptions handling solution to be effective, it must be built on a foundation of fast, targeted, and precise communication between/among the right people. In the overages example above, this would mean the trading partner that received the extra case would know exactly who to contact at the manufacturer, what information to share with that person, and how long it would take to fix the data error.

Are You Ready for EPCIS DSCSA Exceptions Handling?

The FDA’s extended stabilization period has given the pharmaceutical industry an additional year to prepare for the full serialization of the U.S. drug supply chain, including being able to deal with EPCIS DSCSA exceptions handling.

This is good news for everyone. But you have to use this time to ask yourself the tough questions:

- - Do you have systems up and running?
  - Are you testing your systems?
  - Are you communicating and collaborating with all of your trading partners?
  - Are you complying with the DSCSA requirements that are enforceable right now?
  - Are you working with a solution provider that fully understands your role in the supply chain, your product(s), your business, and your DSCSA compliance needs?
  - Are you going to be ready for November 27, 2024?

We are here to help. We have led on the DSCSA since rollout began in 2014. Today, we’re working with the industry to develop a collaborative approach to exceptions handling using GS1-based error correction.

Don’t let bad data disrupt your business. Contact us today to learn more. We’ll ensure you receive compliant data from your trading partners, quickly resolve data quality issues, and keep your products moving.

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.

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.

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.

Join Antares Vision Group at the HDA 2022 Traceability Seminar in October

Posted on September 27, 2022September 26, 2022 by rfxadmin

Antares Vision Group will be at the HDA 2022 Traceability Seminar October 12-14 at the Marriott Marquis in Washington, D.C. We’re an official sponsor, and our team will be there with our latest technologies and solutions. Stop by to meet us!

The HDA 2022 Traceability Seminar brings together healthcare supply chain leaders to learn more about implementation milestones of the DSCSA as distributors, manufacturers, and dispensers implement serialization and traceability technologies.

Attendees also discuss innovative approaches and lessons learned from the first 9 years of the DSCSA rollout and what to expect during the “last mile” of implementation until the November 2023 deadline.

Get the latest DSCSA intel from our experts at the HDA 2022 Traceability Seminar

If you’re reading this, chances are you know that we’ve been leading on the DSCSA since Day 1 and have collaborated with the pharma industry to test key systems, work out kinks, and help all stakeholders prepare. Here are just a few examples:

And it should come as no surprise that Herb Wong, our SVP of product and strategy, will be at the Seminar. He’ll be at our booth, of course, but he’s also doing the “EPCIS Onboarding Across the Supply Chain” panel discussion on Thursday, Oct. 13, from 1:30 to 2:30 p.m.

Herb will also host a Friday morning roundtable about DSCSA readiness. Antares Vision Group is sponsoring the day’s Roundtable Discussions (9:35-10:50 a.m.), where you can discuss operational issues associated with traceability implementation. Choose a topic that interests you and rotate through the tables with your peers. Highlights from the discussions will be shared at the end of the session.

With this experience and knowledge, our team wants to answer your questions and show you our solutions while you’re at the Seminar. No matter how far along you are in your DSCSA preparations, time with our team will be time well spent — informative, interesting, and maybe even game-changing.

Final thoughts

We’re just a year away from the final DSCSA deadline and the full serialization of the U.S. pharmaceutical supply chain. The HDA 2022 Traceability Seminar is really the place to be when it comes to the “right now” of the DSCSA for product identification, product tracing, product verification, and requirements for authorized trading partners.

So bring your DSCSA questions for our team and let us know how things are going. Visit our booth. Sit in on Herb’s Thursday EPCIS panel discussion and his Friday roundtable. If you have 3 minutes, take our DSCSA Readiness Survey. You can also check out our DSCSA Compliance Library for all of our resources about the law.

We hope to see you in October!

DSCSA Compliance Update with Herb Wong: What’s Happening Right Now?

Posted on August 30, 2022November 10, 2023 by rfxadmin

Herb Wong’s a busy guy. We said that the last time we did a DSCSA compliance update with him, and it’s still true today Just last week, for instance, he participated in two Healthcare Distribution Alliance (HDA) webinars, “DSCSA 2023: How a Service Provider Can Help You Prepare” and “All About the VRS.” These were part of the HDA’s 2022 Traceability Webinar Series, which Antares Vision Group is sponsoring.

That’s why it was such a treat to get some one-on-one time with Herb for a real-time DSCSA compliance update — what’s happening right now with industry readiness.

We asked Herb to talk about what he calls “the four cornerstones” of DSCSA compliance: product identification (EPCIS and serialization), product tracing, authorized trading partners (ATPs), and verification (the Verification Router Service, or VRS). Here’s what he had to say.

DSCSA compliance update #1: product identification (EPCIS and serialization)

All solution providers’ systems are ready to send and receive serialization data in the EPCIS format, but we still need to help the industry get data flowing. To use an analogy, even though the pipes have been laid and connected, we’re just not getting enough water through to test for “leaks” in the system — errors in send/receive processing. Just as important, we need time to “flush the pipes” to ensure that we have “clean water.” By that I mean ensuring that the data is correct.

We’re trying to do everything we can. We’ve actually developed a standard process for onboarding customers and getting data exchanged with other solution partners. We’re going to be piloting this so we can refine the onboarding process. [Herb’s talking about the EPCIS Onboarding Guide Workgroup and its draft “Guide for Accelerated EPCIS Onboarding.”]

What’s the key takeaway, Herb?

The key takeaway is, “Let’s connect, let’s get the serialized data out.” Time is running out. That’s the biggest message. People who think they have time to wait until next year, you really don’t. Because what’s going to happen is similar to what happened when the lot-based laws went live: The people who waited couldn’t find help. All the solution providers were busy; everyone was busy. And everyone who waited was trying to get through the same door to meet the deadline.

So, if you’re a manufacturer, you have to start sending data early. If you’re serializing and not sending data downstream, start now. Don’t wait till the November 2023 deadline. You have to “turn on the switch.” Send your data downstream now.

At this point, we decided to ask Herb about aggregation.

DSCSA doesn’t say anything about aggregation. But wholesalers are asking for aggregation to support their business processes. When you send electronic data, wholesalers need to know what serial numbers are in the cases they just received.

Aggregation is a business requirement for operational efficiency. For example, if you get 10 cases with a hundred items in each case, you don’t want to open the cases and scan every item to see what you received and will ultimately ship. Aggregation makes things faster and more efficient. It’s similar to how VRS had both a legal and a business requirement: The legal requirement mandated a response within 24 hours for saleable returns verification. But given the potential volume of saleable returns, 24 hours was too slow for wholesalers; it would cause the receiving docs to fill up with products pending verification. For this reason, wholesalers mandated a business requirement of sub-second response times.

DSCSA compliance update #2: product tracing

A centralized solution or standard has not been defined for product tracing. A lot of different approaches have been discussed, but there’ve been no specs, no firm requirements, that solution providers can implement at this time.

Right now, we’re supporting the industry’s manual process for product tracing. The HDA, NABP, and PDG have done a really good job of outlining what’s required for tracing. [That’s the Healthcare Distribution Alliance, the National Association of Boards of Pharmacy, and the Partnership for DSCSA Governance.]

They’ve walked through a series of scenarios that can be executed manually and have helped the industry to better understand the complexity and nuances of tracing a product through the system. In parallel to this effort, the PDG is working on a data format to communicate traceability requests and responses. PDG is putting that information into a JSON format to communicate the need. [JSON is the JavaScript Object Notation data interchange format. Its advantages are that it uses human-readable text and is a more compact means of communicating data.]

What’s the key takeaway, Herb?

Pay attention to the traceability scenarios that are coming out of the HDA, NABP, and PDG. They’re doing a really good job of trying to show how tracing workflows will happen. They’ll be publishing more results and helping the industry understand. Watch for these, because it will enlighten you about what’s coming in 2023.

DSCSA compliance update #3 and #4: ATPs and VRS

From a solution provider standpoint, the ATP and VRS initiatives have become one and the same. Right now, ATPs have only been applied against the VRS, so the timing for us to get that done has become one implementation effort.

When you make a VRS request, you have to prove you’re an ATP. ATP is there to confirm two things: you are who you say you are and you are authorized to transact business. Proof that you are an ATP is especially important in the VRS network since trading partners may not have direct relationships with other VRS participants.

For VRS, there’s a new version 1.3 that will be deployed before the DSCSA 2023 deadline. The current version we have is based on the 1.2 standards interface. The 1.3 version “opens up” VRS beyond what it was intended to do, which is the verification of saleable returns.

What people should know is that VRS 1.3 is not backwards-compatible. This means VRS providers have to upgrade at once. To ensure that the upgrade occurs on time, solution providers have agreed to “decouple” the 1.3 interface from the 1.3 functionality.

What this means is that everyone on the VRS network will remain connected since we will all support the new 1.3 connections. However, solution providers (or customers) who are not ready to upgrade to the new 1.3 functionality can continue to use VRS as needed. That’s going to be important because it allows us to change the interface so we can at least keep talking to each other. We can be interoperable. But not everyone has to support the features of 1.3 at the same time.

As for timing of the update, we’re talking about doing the testing of the interoperability of 1.3 in Q1 [of 2023]. So we’ll have to push this into a production environment after Q1, but we haven’t agreed on a production date.

What’s the key takeaway, Herb?

There is going to be an upgrade required soon and the industry and solution providers are working to make sure it’s easy to implement. We realize that is not as simple as a software upgrade but we need to carefully consider the revalidation requirements of our customers.

Final thoughts

And there you have it: A DSCSA compliance update about what’s happening right now with industry readiness for product identification (EPCIS and serialization), product tracing, and ATPs and VRS. Thanks, Herb!

Contact us if you have questions about what Herb talked about or the DSCSA in general. We can explain the requirements and how our solutions will help ensure you’re ready for November 2023 and the full serialization of the U.S. pharmaceutical supply chain.

If you like, we can probably arrange a meeting with Herb. But remember, he’s busy. In the coming weeks, he’ll travel to the Antares Vision Group global HQ in Italy, visit the Group’s brand-new North America HQ in New Jersey, and join a panel discussion at the HDA Traceability Seminar in Washington, D.C. (Antares Vision Group is also a sponsor of that annual event.) So reach out today and let’s see what we can work out.

Also take a look at our DSCSA Compliance Library. It’s a clearinghouse of information with links to our blog posts, white papers, webinars — everything — about the law, including the “four cornerstones” Herb talked about in today’s DSCSA compliance update.

Understanding FDA DSCSA Guidance for the Pharmaceutical Industry

Posted on August 18, 2022December 19, 2023 by rfxadmin

The Drug Supply Chain Security Act (DSCSA) was passed 10 years ago in November 2013. Congress created the legislation to secure the U.S. pharmaceutical supply chain through unit-level product identification (serialization) and electronic exchange of product information.

Over the years, the FDA has issued updates and revised DSCSA guidance for manufacturers, dispensers, wholesale distributors, and other pharma stakeholders. If your products and/or operations are regulated by the law, it is vital to remain aware of requirements, changes, and deadlines.

Let’s explore the DSCSA guidance and requirements and what the FDA has done in recent years.

What Is the DSCSA?

Created as Title II of the Drug Quality and Security Act (DQSA), passed by Congress in November 2013, the DSCSA is an initiative to prevent the introduction and distribution of counterfeit, stolen, contaminated, or otherwise harmful drugs in the United States. It outlines steps to build an interoperable electronic system to identify and trace prescription drugs as they are distributed throughout the country.

Who Must Comply with the DSCSA?

Manufacturers, wholesale distributors, repackagers, dispensers (i.e., pharmacies, healthcare systems), and third-party logistics providers (3PLs) all have requirements with which they must comply.

Recent DSCSA Guidance Updates

Recently, the most notable action from the FDA was its announcement in August 2023 that it was delaying by one year enforcement of key DSCSA requirements. This “extended stabilization period” moves the enforcement date to November 27, 2024.

This DSCSA guidance primarily affects manufacturers, wholesale distributors, dispensers, and repackagers; delayed enforcement pertains to product identifiers (PIs) at the package level; saleable returns; interoperable, electronic product tracing; and investigating suspect and illegitimate products.

Though this gives the industry more time to comply, the Agency has made it clear that the postponement doesn’t amount to a grace period. It said the stabilization period was “not intended to provide, and should not be viewed as providing, a justification for delaying efforts by trading partners to implement the enhanced drug distribution security requirements.”

You can read the FDA’s official document about the stabilization period here.

Other Noteworthy DSCSA Guidance Updates

July 25, 2022: The FDA published a proposed rule, “Revising the National Drug Code Format and Drug Label Barcode Requirements.” The National Drug Code, or NDC, is the Agency’s “standard for uniquely identifying drugs marketed in the United States.” The codes are usually found on product labeling and might be part of the universal product code (UPC). Read more about the NDC and what the FDA said here.

October 23, 2021: In a policy document, the FDA announced it was delaying enforcement of key requirements to verify saleable returns. It also included guidance for wholesale distributors concerning transaction statements under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The timeline below provides an at-a-glance view of DSCSA guidance as the law has been rolled out over the last decade.

DSCSA Guidance in Context, Today

The stabilization period announced in August 2023 did not, in fact, change the original compliance deadline of November 27, 2023; it is up to individual states to decide if they’re going to enforce the requirements before November 2024.

However, the FDA said extending enforcement will give supply chain stakeholders 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.”

What DSCSA Requirements Are in Effect Right Now?

It follows from what we just said that there is DSCSA guidance in effect right now. Some digressions are prohibited per the FD&C Act and can be enforced — with consequences ranging from product seizure to fines to imprisonment. Both federal and state authorities may take action against DSCSA violations.

What Was Enforceable Before Nov. 27, 2023?

Here are a few regulations that can be enforced now. For a full list, see the National Association of Boards of Pharmacy’s (NABP’s) excellent article here. (And also be sure to read about how we were the first DSCSA solution provider to join NABP’s Pulse Interoperable Partner Program. Learn more here!)

All trading partners must be authorized trading partners (ATPs) and can only buy, sell, or trade with other ATPs.
ATPs must be able to identify and manage suspect and illegitimate products.
A product identifier (PI) must be placed on all regulated drug packages and homogenous cases — except for grandfathered products or products with an FDA waiver, exception, or exemption.
ATPs must provide certain information about a drug and who handled it each time it’s sold: transaction information (TI), transaction statement (TS), and transaction history (TH).

What Went into Effect on Nov. 27, 2023?

The November 2023 deadline was when enhanced security requirements went into effect. We’ve written extensively about this for years (in our recently updated DSCSA white paper, for example), but here’s a summary of what companies must do to comply:

Exchange TI and TS securely, electronically, and interoperably. TI must include each package’s unique identifier.
Verify PIs at the package level.
Respond to appropriate tracing requests and trace products at the package level (serialization).
Associate saleable returns with the TI and TS associated with its initial sale.

Final Thoughts About DSCSA Guidance

So what’s the upshot of all this information? It’s simple: Don’t stop preparing.

Use your extra time during the stabilization period to evaluate your systems, communicate and coordinate with your trading partners, and — importantly — ensure you’re working with a solution provider that knows the DSCSA guidance inside and out.

If you have questions about the DSCSA 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.

Antares Vision Group Will Be at GS1 Connect 2022 in San Diego Next Month!

Posted on May 23, 2022August 4, 2023 by rfxadmin

We’re getting excited for GS1 Connect, June 7-9 at the Marriott Marquis San Diego Marina! Not only are we a Premier Sponsor — we’ll be speaking about supply chain traceability and smart hospital systems.

We’ll also be at Booth 115 with our award-winning Traceability System, demonstrating solutions for the food and beverage, pharmaceuticals, and cosmetics industries.

So take 20 seconds (really) to sign up to meet us. We have a limited number of discount codes for 10 percent off your registration fee. And while you’re at Booth 115, take our short survey and you could win a $500 DoorDash gift card.

More about GS1 Connect and our speakers

The theme of this year’s conference is “Adapt.” The focus is on how businesses have used GS1 Standards to overcome challenges to thrive in uncertain times. There will be 40+ live sessions (including ours!), 50+ exhibitors (including us!), trading partner roundtables, and other events centered on user stories and leadership insights for supply chain optimization.

As GS1 says, the event is a place to “network with the greatest supply chain minds and learn how to leverage GS1 Standards to optimize your business.” Indeed.

In “Supply Chain Traceability: Can Your Business Survive Without It?” Herb Wong, our vice president of product and strategy, will discuss why traceability is foundational to business success in a rapidly evolving landscape of digitalization, ever-changing consumer expectations and power dynamics, tougher regulations, and supply chain uncertainty. He’ll be speaking on Thursday, June 9, at 1:45 p.m.

In on-demand session 509, “Smarter and Safer Hospitals: When Innovative Technologies Meet Patient Safety,” our Digital Healthcare Department Director Adriano Fusco and Dr. Alberto Sanna, director of the Research Center for Advanced Technologies for Health and Well-Being of the IRCCS San Raffaele Hospital in Milan, Italy, will discuss how traceability and GS1 Standards enable end-to-end visibility of medications from arrival at the hospital to dispensation and optimized resources to focus on patient safety.

Final thoughts

We’ve always valued GS1 Standards, and we’ve always ensured our customers can adhere to them and take full advantage of them to maximize efficiency and create value across their operations everywhere they do business.

And who took the time to note the 50th anniversary of the venerable Global Trade Item Number (GTIN)? We did, with a blog post devoted to GS1 barcodes.

As we said in that article, “Where would we be without standards?” We’d love to see you at GS1 Connect and talk about those standards and how they fuel traceability. We hope you’ll take those few seconds to sign up to meet us at Booth 115, get 10 percent off your registration, and enter to win a nice prize when you take our survey.

In the meantime, drop us a line if you have any questions or want to know more about our traceability solutions for pharma, food and beverage, cosmetics, and other industries. We never pass on an opportunity to talk about what makes us your best partner for end-to-end supply chain solutions, from L1 all the way to L5!

See you in San Diego June 7-9!