Category: blog

If you’re already using TraceLink’s Track and Trace solution, you know the power of real-time product visibility, seamless compliance, and streamlined serialization. But let’s be honest—tracking products across an increasingly complex supply chain isn’t always smooth sailing. Errors creep in, data gets messy, and you need more than just visibility when compliance deadlines loom. You need control.

That’s where DIAMIND Sentry comes in. Pairing DIAMIND Sentry with your existing Track and Trace solution isn’t just a good idea—it’s the upgrade your operation needs to keep things running without a hitch. Let’s break it down.

TraceLink Track and Trace: The Basics—But Is It Enough?

By now, you know what TraceLink offers. It’s a cloud-based system that serializes pharmaceutical products, connects stakeholders, and helps companies meet compliance requirements. For some companies, this might be enough. But even the best track-and-trace system has a weak spot—data integrity and error handling. That’s where things get tricky.

Where Track and TraceLeaves Gaps

Despite its strengths, Track and Trace doesn’t automatically fix bad data. Errors in EPCIS files, incomplete transaction records, and miscommunications between supply chain partners can derail compliance efforts and delay shipments. If you’ve ever had to untangle an EPCIS data mess manually, you know the pain.

Wouldn’t it be better if those errors were caught before they became a problem?

DIAMIND Sentry: Your Safety Net

DIAMIND Sentry was designed to handle the gaps that the Track and Trace solution leaves open. It’s an intelligent error-handling and transaction-monitoring tool that works alongside Track and Trace to clean up data issues before they spiral out of control. Here’s what you get:

• Automated EPCIS file evaluation – Stop chasing down compliance errors. Sentry flags and fixes data discrepancies automatically.
• Advanced error handling – Detailed validation reports mean no more guesswork.
• Real-time dashboards – Monitor data flows, identify trends, and spot issues early.
• Collaborative issue resolution – Automated notifications and ticketing streamline communication across teams.
• Seamless integration – Works with your existing systems without a headache.

In short, DIAMIND Sentry doesn’t replace TraceLink’s Track and Trace solution—it makes it smarter, more efficient, and more reliable.

The Real Benefits of Using Both

Still wondering if you really need DIAMIND Sentry? Here’s what happens when you use it alongside TraceLink’s Track and Trace solution:

• Fewer Disruptions – Transaction errors no longer bring operations to a grinding halt.
• Stronger Compliance – DSCSA requirements are met without last-minute scrambles.
• Lower Costs –With better efficiency, labor expenses are minimized, making operations more cost-effective.
• Better Collaboration – Internal teams and external partners stay aligned without endless email chains.
• Improved Data Quality – Clean, accurate data leads to better decision-making and fewer surprises.

Why Settle for Half the Solution?

Think of it this way—TraceLink’s Track and Trace solution gets you on the road, but it doesn’t tell you what’s ahead. Without deeper insights, you’re stuck reacting to problems instead of preventing them. Gaps in data integrity, error handling, and real-time visibility leave you exposed to compliance risks and inefficiencies.

If you rely solely on TraceLink’s Track and Trace solution, you’re operating with blind spots. When compliance, efficiency, and accuracy are on the line, you need more than just basic serialization—you need a system that anticipates risks before they become costly issues.

It’s time to go beyond Track and Trace. Contact us today to see DIAMIND Sentry in action!

Pharmaceutical companies operate in one of the most highly regulated industries in the world. Managing compliance, ensuring product safety, and preventing counterfeit drugs are non-negotiable. That’s why track-and-trace solutions have become essential—but not all solutions are created equal. 

On the surface, TraceLink Track and Trace and rfxcel Traceability Solution (rTS) might seem similar. Both offer serialization, real-time monitoring, and compliance management. But when it comes to delivering true visibility, security, and flexibility, the differences are significant. Let’s explore why rTS is the superior choice.

The Illusion of Control: Where TraceLink Falls Apart

At first glance, TraceLink Track and Trace is a solid compliance solution. It’s cloud-based, offers real-time monitoring, and connects supply chain stakeholders. However, a closer look reveals some notable challenges.

The first significant issue is TraceLink’s multi-tenant cloud-based infrastructure. While cloud models provide convenience, they can also introduce limitations. Track and Trace’s single cloud environment means customers share resources, which can lead to potential performance bottlenecks. Additionally, companies must adhere to TraceLink’s update schedule, sometimes receiving system changes that may not align with their operational priorities. 

In contrast, rTS offers both cloud and on-premise deployment options, giving businesses control over their compliance environment. This flexibility ensures that organizations can align the software with their specific security policies and operational needs rather than being locked into a single provider’s ecosystem.

Another critical distinction is TraceLink’s approach to serialization. While serialization assigns unique identifiers to products, it does not automatically equate to full traceability. Without comprehensive data validation and advanced actionable insights, serialization alone does not provide end-to-end supply chain visibility.

rTS, on the other hand, offers a complete traceability framework to include comprehensive data verification, seamless integration with global reporting systems, and robust analytics. This ensures companies achieve superior transparency, from raw materials to finished goods, minimizing risk and enhancing supply chain security.

Compliance Management: A Tailored Approach

TraceLink’s compliance management capabilities follow a standardized framework designed to meet generic regulatory requirements. However, this rigid structure may not accommodate the specific operational workflows of different pharmaceutical companies. As a result, businesses may have to adjust their processes to fit the software rather than using a system tailored to their needs.

rTS takes a more flexible approach by allowing companies to customize compliance workflows. The solution supports industry-specific reporting requirements, integrates with global regulatory agencies, and ensures compliance efforts align with real-world operations. By offering automation, customizable rules, and seamless data exchange, rTS simplifies compliance management while enhancing overall efficiency.

The Clear Winner: rTS

If Track and Trace meets the minimum compliance requirements, rTS is the gold standard. It ensures data quality and accuracy through extensive validation and enrichment processes. Unlike solutions that rely largely on serialized numbers, rTS cross-references and verifies each data point, reducing errors and improving traceability across the supply chain.

Enhanced real-time monitoring is another area where rTS excels. While TraceLink provides real-time tracking, rTS leverages IoT-based tracking and sophisticated analytics to offer deep visibility into supply chain movements. This level of insight allows pharmaceutical companies to proactively manage product safety, prevent counterfeiting, and address disruptions before they escalate.

The most significant advantage of rTS is that it extends beyond compliance to provide actionable business intelligence. Compliance is not just about avoiding penalties—it’s about optimizing supply chain operations, improving efficiency, and reducing costs. With advanced analytics and predictive insights, this solution helps companies make smarter decisions based on real-time data. Businesses can identify inefficiencies, anticipate potential disruptions, and gain deeper insights into supply chain dynamics while maintaining full regulatory compliance.

The Bottom Line: Choose a Competitive Edge, Not Just Compliance

Pharmaceutical compliance isn’t optional—but your choice of compliance software is.  While Track and Trace provides a functional compliance solution, it lacks the control, visibility, and adaptability that pharmaceutical companies need. Businesses relying on TraceLink may face limitations in customization, data access, and operational flexibility.

rTS  is about future-proofing supply chains, eliminating inefficiencies, and achieving true end-to-end visibility. With its superior data validation, enhanced real-time monitoring, seamless integration, and business intelligence capabilities, rTS is the clear choice for pharmaceutical companies that demand more than just the bare minimum.

Choosing the right compliance software isn’t just about meeting regulatory standards—it’s about ensuring product safety, maintaining operational efficiency, and staying ahead in an industry where precision and transparency are paramount.  See how rTS provides real-time visibility, security, and control beyond the basics.

Contact us today to see rTS in action!

Managing warehouse operations shouldn’t feel like a never-ending puzzle. Yet, for businesses juggling serialized and non-serialized products, it often does. The challenge? Keeping compliance in check, ensuring inventory accuracy, and streamlining operations—all without sinking time and money into inefficiencies. That’s where EDGE Warehouse Solution steps in.

This isn’t just another warehouse management system (WMS). EDGE is a data collection and tracking solution that integrates directly with compliance and traceability platforms. It is indispensable to existing systems like Manhattan, Blue Yonder, or SAP WMS. Whether dealing with pharmaceuticals, consumer goods, or industrial equipment, EDGE simplifies warehouse tracking while ensuring you meet global regulations, from DSCSA in the U.S. to EU FMD and Brazil ANVISA.

What Makes EDGE Warehouse Solution Different?

Unlike traditional warehouse management tools, EDGE does more than just help move inventory from Point A to Point B. It ensures every product is tracked properly—serialized or not—without complicating your workflow.

Here’s how:

• Accurate Data Capture: EDGE seamlessly integrates with ERP, WMS, EPCIS repositories, and serial number management systems to keep inventory records precise.
• Aggregation & Disaggregation of Serialized Data: It simplifies how you track, manage, and verify serialized items—critical for industries with strict compliance demands.
• Flexible Deployment: EDGE is a standalone solution for smaller businesses or a fully integrated system for large-scale operations with multiple distribution centers.
• Hardware Agnostic: Compatible with ZEBRA and other industry-standard hardware, it lets you keep your existing infrastructure.
• User-Friendly Interface: Employees don’t need to determine which products require serialization tracking—EDGE does the thinking for them.

Why Businesses Are Turning to EDGE

Compliance regulations aren’t getting any simpler. Governments worldwide are tightening serialization rules, and businesses that fail to meet them risk fines, shipment delays, or worse—losing contracts.

EDGE Warehouse Solution takes the guesswork out of compliance by ensuring all required data is collected, stored, and easily retrievable. This is especially valuable for industries like:

• Pharmaceuticals and Healthcare: Serialization laws are non-negotiable in this sector. EDGE helps businesses stay compliant while keeping product flow efficient.
• Food & Beverage: With growing traceability requirements, companies need reliable tracking to meet FDA and international food safety standards.
• Consumer Goods & Retail: Inventory accuracy and shipment verification are critical for supply chain success. EDGE prevents costly errors.

How EDGE Boosts Warehouse Efficiency

Speed and accuracy make or break warehouse operations. EDGE optimizes key processes to reduce labor costs, cycle times, and shipment errors.

• Pick, Pack, and Ship Scenarios: It simplifies order fulfillment, reducing manual entry and potential mistakes.
• Shipment Verification: Ensure everything that leaves the warehouse is precisely what was ordered—no surprises.
• Customized Workflows: Whether you run a single facility or multiple locations, EDGE adapts to your processes, not the other way around.

Implementation: Fast, Painless, and Fully Supported

Unlike other solutions that require extensive (and expensive) customization, EDGE is ready to go out of the box. Our team handles implementation from start to finish—no surprise fees, no unnecessary downtime.

• You get a dedicated team to configure EDGE for your needs.
• We help source and integrate any necessary hardware.
• Training and ongoing support ensure your staff can use the system effectively from day one.

Ready to See EDGE in Action?

EDGE Warehouse Solution simplifies compliance, optimizes warehouse operations, and eliminates the headaches of managing serialized and non-serialized inventory. Want to see how it fits into your workflow?

Request a Demo Today

Temperature-sensitive products, from life-saving vaccines to fresh produce, require precise handling to maintain quality and safety. A single temperature fluctuation can render a pharmaceutical shipment useless or cause food to spoil before it reaches the consumer. That’s where cold chain technology comes in.

Our cold chain solution is more than just refrigerated storage and transportation; it’s a sophisticated network of sensors, data analytics, and real-time monitoring designed to protect high-value goods at every step. With stricter regulatory requirements and rising consumer expectations, businesses can’t afford to leave temperature control to chance.

What is Cold Chain Technology?

Cold chain technology refers to the systems and processes transporting and storing temperature-sensitive products while maintaining optimal conditions. These products often include vaccines, biologics, insulin, and perishable foods, which can lose effectiveness or spoil if exposed to unsuitable temperatures.

The primary goal of cold chain technology is to ensure the integrity and quality of these products through precise temperature monitoring, robust data collection, and timely interventions. In other words, it safeguards compliance with industry standards and regulatory frameworks while also preventing financial losses caused by degraded products.

How Cold Chain Technology Works

Our Cold Chain solution offers real-time visibility and control, ensuring products stay within the required parameters. To understand how this works in practice, let’s break down the key components of an effective cold chain system:

• Item-Level Tracking: Every product is monitored in real-time, ensuring that individual units—not just entire shipments—are accounted for. The system precisely tracks conditions, whether it’s a batch of vaccines or perishable seafood.
• Smart Sensors & Data Capture: Advanced IoT sensors, RFID tags, and barcodes collect critical information, such as temperature deviations, duration of exposure, and handling history.
• AI-Driven Insights: Machine learning algorithms analyze real-time data to detect inefficiencies, predict risks, and suggest preventive actions before issues arise.
• Immediate Alerts & Compliance Reporting: If temperatures shift outside safe ranges, instant notifications trigger corrective actions. Detailed reports ensure compliance with industry regulations, minimizing liability and waste.

Why Cold Chain Technology Matters

The stakes are high for businesses managing temperature-sensitive products. A single lapse in maintaining optimal conditions can lead to product degradation, loss of consumer trust, and regulatory repercussions. Cold chain technology mitigates these risks by offering end-to-end visibility, proactive management, and robust data analytics.

Take pharmaceuticals: a vaccine that overheats by just a few degrees may lose its potency. Without a robust cold chain system, businesses risk costly recalls, regulatory penalties, and reputation damage.

Food distribution faces similar stakes. Bacteria multiply rapidly when food isn’t stored at proper temperatures, increasing the risk of contamination. Cold chain solutions prevent these issues, reducing waste and ensuring consumers receive fresh, safe products.

Transform Your Supply Chain with Antares Vision Group

Antares Vision Group’s Cold Chain solution empowers businesses to redefine their supply chain operations. Combining cutting-edge technology with seamless integration ensures transparency, efficiency, and reliability. Businesses can safeguard their products and achieve outstanding operational excellence, compliance, and profitability.

The future of cold chain technology lies in its ability to adapt to growing complexities in global supply chains. With features like AI-driven analytics and real-time monitoring, Antares Vision Group is setting the standard for what’s possible in protecting temperature-sensitive goods.

Experience the transformative impact of advanced cold chain solutions. Request a demo today to learn how to protect your products and maximize your supply chain’s potential.

The pharmaceutical supply chain is complex, and with the Drug Supply Chain Security Act (DSCSA) in full effect, manufacturers, wholesalers, and dispensers must ensure compliance while maintaining seamless operations. Choosing the right Error Handling and Transaction Monitoring solution is critical for avoiding costly disruptions. LSPedia Investigator and DIAMIND Sentry both provide exception handling and compliance tools, but they differ significantly in their capabilities, automation, and user experience. Let’s compare them based on key factors.

Automated Error Handling

Both solutions validate EPCIS files to detect syntax, data integrity, and business rule violations. However, DIAMIND Sentry takes it a step further by including full validation reports at no additional cost.

LSPedia Investigator identifies EPCIS errors and sends real-time email alerts to the responsible Point of Contact (PoC). Errors must be manually reviewed and resolved via email, with users resubmitting corrected files.

DIAMIND Sentry automates the entire error-handling process. A single validation report summarizes all errors in inbound and outbound files, categorizing them by severity. Depending on the issue, files are blocked, flagged for review, or sent back to partners for correction—eliminating the need for manual tracking.

Investigator provides compliance validation based on DSCSA and GS1 standards and allows error resolution via live email links. DIAMIND Sentry expands on this by providing real-time dashboards and configurable rulebooks, ensuring more precise error detection and correction while reducing false positives.

Compliance Without the Hassle

Staying DSCSA-compliant shouldn’t feel like a full-time job. The Investigator provides compliance validation based on DSCSA and GS1 standards and allows error resolution via live email links. However, DIAMIND Sentry expands on this by integrating compliance seamlessly into daily operations. Instead of making users chase down violations, it presents a clear, organized view of all transactions and flags anything that needs attention—before it becomes a problem.

Plus, DIAMIND Sentry ensures all transactions meet DSCSA requirements right out of the gate. No guesswork, no delays. Just smooth, automated compliance.

Purchase Order Tracking: Business Insights You Won’t Get Elsewhere

Compliance isn’t the only challenge in managing the pharmaceutical supply chain—accurately tracking purchase orders (PO) is just as critical.

DIAMIND Sentry’s PO Tracker is a built-in business report that offers full visibility into purchase order status. It enables you to track orders in real-time, monitor progress, and identify discrepancies before they lead to delays, giving you a sense of security and control over your supply chain.

With PO Tracker, you don’t just monitor compliance—you gain a complete operational overview that helps improve forecasting, prevent disruptions, and keep everything running smoothly.

Collaboration That Works

Errors don’t fix themselves—people do. That’s why collaboration tools matter. Investigator sends error notifications and provides live links for resolution. But DIAMIND Sentry takes teamwork up a notch with built-in ticketing and automated workflows. Need to loop in a partner to fix an issue? No problem. Sentry keeps everyone in the loop without the back-and-forth email chains.

And because DIAMIND Sentry is designed for manufacturers, wholesalers, and dispensers alike, it fosters a shared approach to problem-solving across the entire supply chain. It allows everyone to get the visibility they need.

Visibility and Ease of Use: No Contest

You shouldn’t need a degree in data science to navigate your Error Handling and Transaction Monitoring system. The Investigator is functional, but relying on emails can reduce efficiency. DIAMIND Sentry, on the other hand, offers a modern, user-friendly interface with mobile access, real-time dashboards, and customizable views. Whether you’re in the office or on the go, your data is always at your fingertips.

The Bottom Line: DIAMIND Sentry Wins

Let’s be honest. DSCSA compliance is complicated enough without adding unnecessary frustration. You need a modern, intelligent solution that prevents compliance issues before they happen, keeps your supply chain moving seamlessly, and saves you money. DIAMIND Sentry isn’t just another Error Handling and Transaction Monitoring tool—it’s the right solution for DSCA Compliance.

Schedule a demo today and see the difference DIAMIND Sentry can make.

In today’s highly complex and interconnected global economy, efficient supply chain management is crucial for businesses aiming to maintain seamless operations and mitigate risks. DIAMIND Sentry is designed to provide businesses with a comprehensive solution for ensuring supply chain continuity, regulatory compliance, and operational efficiency. By leveraging advanced technology, real-time monitoring, and robust exception handling, DIAMIND Sentry helps companies streamline processes, reduce manual effort, and protect their operations from potential disruptions.

In this blog, we will discuss the benefits and values that DIAMIND Sentry can bring to your business, how its exception-handling capabilities can safeguard against unforeseen challenges, and why it is right for you.

What is DIAMIND Sentry?

DIAMIND Sentry is an advanced solution designed to simplify exception handling and ensure smooth operational workflows while supporting compliance with the Drug Supply Chain Security Act (DSCSA). Tailored for the pharmaceutical industry, this tool improves data quality, streamlines processes, and fosters collaborative decision-making, making it indispensable for regulatory compliance.

Our platform integrates with supply chain systems to provide centralized control over exception handling and data integration. Its real-time automation of compliance checks and data exception management enhances operational efficiency and regulatory readiness, empowering businesses to meet compliance requirements with ease and confidence.

How Does DIAMIND Sentry Work? 

DIAMIND Sentry revolutionizes exception management by streamlining the entire process, making it faster and more efficient. At the heart of its functionality is automated EPCIS file evaluation, which meticulously validates inbound and outbound files. The platform conducts prechecks for format and master data alignment, effortlessly ensuring that all transactions adhere to DSCSA standards and meet compliance requirements.

The solution also excels in error reporting by generating a comprehensive validation report highlighting all detected issues. Errors are categorized based on criticality, enabling targeted responses such as file blocking, flagging for review, or sending them back to partners for correction. This precision reduces confusion and accelerates resolution.

Collaboration is further simplified through automated notifications and ticketing systems, which enhance communication with partners. This integration allows issues to be resolved directly through email responses, triggering automated follow-ups or reprocessing. By fostering seamless collaboration, DIAMIND Sentry minimizes delays and manual interventions.

Finally, real-time monitoring ensures that users maintain complete visibility into their operations. Customizable dashboards provide actionable insights into exception statuses, data flows, and purchase order tracking. This transparency not only aids in decision-making but also ensures adherence to compliance standards, solidifying DIAMIND Sentry’s role as a critical tool for exception management.

Why DIAMIND Sentry?

DIAMIND Sentry stands out for its advanced technology, ease of use, and ability to address the most critical supply chain challenges businesses face today. With its configurable rulebooks, the solution can be tailored to meet specific business needs, offering flexibility and scalability. Companies can customize their workflows and processes without investing in complex coding or expensive system modifications.

Another key advantage of this solution is its automated communications feature, which eliminates manual file interrogation. This self-service resolution capability empowers teams to resolve issues independently, reducing the need for constant IT support. With automated processes, businesses can ensure faster turnaround times, reduce operational bottlenecks, and improve overall supply chain efficiency.

Additionally, DIAMIND Sentry’s real-time data monitoring and advanced exception management capabilities enable businesses to stay ahead of potential disruptions. By providing complete visibility into the supply chain, companies can proactively identify issues and take corrective action, ensuring uninterrupted operations.

Partnering with Antares Vision Group

Partnering with Antares Vision Group gives businesses access to DIAMIND Sentry and expert support to achieve supply chain excellence. With deep industry knowledge and advanced technology, we provide tailored solutions to meet specific needs.

Choosing DIAMIND Sentry means investing in a cutting-edge solution backed by a company that understands the complexities of supply chain management. Our solution helps optimize operations, reduce costs, and achieve business goals.

Ready to see how DIAMIND Sentry can transform your supply chain? Book a demo today and experience the difference firsthand.

Here we are as an aggregate of the Rx supply chain entities and solution providers now more than 10 years out from the inception of DSCSA, and find ourselves marching through yet another year of grace as the “Stabilization Period” is slipping away. Many are at other personal milestones such as 10 cups of coffee per day wondering if we’ll ever be ready as an industry to fully meet the DSCSA requirements as mandated.

It should be noted that this is all a great paradigm against old ways of working from a data and process perspective. Change is painful – change is hard.

In the spirit of “never say never”, whilst the industry ramps up the volume of EPCIS data transactions and accompanying physical shipments, a team has been silently plodding away fighting the good fight against exception management for the benefit of all in their aspiration of sharing valuable insights and outcomes from their efforts. It’s high time their silent efforts be showcased for deserved recognition.

Being clear in the challenge presented by exceptions, they will be ever present ongoing – they are inherently within the nature of the beast of supply chain management. In order to address the DSCSA EPCIS data and physical exception challenges in a scalable and sustainable fashion – the devil is in the details.

End-to-End Testing Overview:

Antares Vision, through its subsidiary rfxcel, is embarking on a groundbreaking End-to-End Exception (E3) testing initiative, in collaboration with esteemed industry leaders, including Sanofi, Axway, Option Care Health, and Movilitas Cloud. This initiative dives into the details and aims to establish new industry protocols for exception handling by leveraging a novel collaboration mechanism and integrating physical and digital testing methodologies.

Key Innovations:

1. Establishing New Industry Process Standards: Collaborate with customers and solution providers to set transparent and accessible standards for exception handling.
2. Utilizing Novel Collaboration Mechanisms: Introduce a new collaboration mechanism and leverage an open contact list provided by NABP to access vendor and supplier contact information.
3. Efficient Error Resubmission Mechanism: Develop the ability to resubmit only the error detail, based on GS1 standards, to enhance
   efficiency and reduce redundancy in data submission processes.
4. Comprehensive Testing Including Dispensers: Include dispensers in the testing phase to identify a larger list of exceptions and ensure a thorough and comprehensive E2E supply chain testing process.

Testing Methodology:
The testing will involve a combination of physical and digital testing, facilitated by rfxcel’s provision of barcodes and coordination efforts. This multidimensional approach will enable comprehensive testing of systems’ capabilities and facilitate the identification of potential exceptions across the supply chain.

Outcome:
Through this collaborative effort, Antares Vision and its partners aim to drive industry-wide improvements in exception handling processes, ultimately enhancing efficiency, transparency, and compliance in the DSCSA supply chain.

Good luck, Godspeed, and thanks for your efforts from the Rx supply chain at-large!

The Food Safety Modernization Act, or FSMA, is unquestionably one of the most significant legal frameworks for the food supply chain. Signed into law in the early 2010s, this U.S. food regulatory framework implemented risk-based preventive controls for certain animal foods and produce to improve safety and mitigate the risks of foodborne illness outbreaks.

While the FSMA has been in effect for several years, it continues to evolve. Moreover, regulatory entities have ramped up verification activities, including FSMA compliance audits, which have raised the stakes for organizations subject to this framework.

Start on the road toward FSMA compliance by checking out this blog. In addition to  a comprehensive overview of FSMA requirements, you’ll learn practical tips for adhering to U.S. Food and Drug Administration (FDA) and U.S. Department of Agriculture (USDA) guidelines.

Understanding FSMA Requirements

FSMA rules introduce several key requirements designed to prevent food hazards and ensure the safety of the food supply chain. The specific requirements that apply to your business may vary slightly depending on your position within the supply chain. However, some of the general guidelines are as follows:

• Preventive controls
• Supplier verification
• Hazard analysis and risk-based preventive controls (HARPC)
• Food defense

It’s helpful to unpack each of these stipulations. Regarding preventive controls, food facilities must develop and enforce a food safety plan, which should focus on identifying and addressing hazards that may impact consumer safety. Your strategy should be based on hazard analysis principles.

Additionally, you must establish foreign supplier verification programs to ensure that raw materials and ingredients obtained from importers meet FDA Food Safety Modernization Act requirements. As part of your HARPC efforts, you must conduct hazard analysis and implement risk-based preventive controls to mitigate identified vulnerabilities.

Finally, the FSMA emphasizes the importance of protecting the food supply chain from intentional adulteration and requires your facility to develop defense plans. These strategies should identify and mitigate potential hazards. Compliance with FSMA requirements is critical for your company’s ability to reduce safety risks, protect consumers, and maintain regulatory compliance.

Assessing Your Current Status

Before you can learn how to start FSMA compliance, it’s essential to know where you currently stand. You can do this by conducting an FSMA compliance audit evaluating your sanitation controls, safe food practices, and other procedures. More importantly, an audit will identify areas where your existing processes fall short of FSMA 204 final rule regulations.

Once you have identified gaps in your current processes, you can implement more stringent preventive controls for human food and take other corrective actions to ensure the safety of food products. While assessing your current compliance posture, make sure to account for other food safety laws, such as the Federal Food, Drug, and Cosmetic Act.

Most importantly, remember that meeting food safety regulations is not a one-time process. You must commit to continuous improvement to meet ever-tightening safety standards. Also, it’s crucial to develop stringent record-keeping requirements to demonstrate your adherence to FSMA regulations and food traceability requirements.

Developing a Compliance Plan

After you’ve determined your organization’s position regarding FSMA traceability stipulations, you can implement mitigation strategies to address identified hazards and ensure compliance.

Consider which specific requirements apply to your organization. The rules you are subject to will change based on your position within the food industry.

For instance, distributors, growers, and food manufacturers face a separate set of guidelines from small businesses that engage in direct-to-consumer sales. You can create a custom compliance plan after identifying which aspects of the rule apply to your company.

When crafting your plan, it’s important to set clear objectives for achieving FSMA compliance, including specific goals and milestones. Next, identify what resources you’ll need to achieve your stated aims. These include personnel, time, and budgetary resources, as well as any technologies or tools.

Develop timelines and action plans for implementing necessary changes and achieving compliance milestones. Remember, too, that most compliance dates under the FSMA have already passed, which means the act and its rules are currently in force. Therefore, time is of the essence.

Conducting FSMA Compliance Audits

FSMA compliance audits play a crucial role in verifying your adherence to regulatory requirements and identifying areas for improvement. Your business can conduct internal audits or obtain accredited third-party certifications to ensure that your current good manufacturing practices align with the provisions of the current food safety system.

The audit process involves three key components:

1. Preparation: Prepare by reviewing FSMA requirements and gathering relevant documentation
2. On-Site Assessment: Auditors will review your documents and observe processes
3. Post-Audit Activities: Address findings or non-conformities and implement corrective actions

Selecting experienced auditors and adequately preparing for audits are essential steps for ensuring adherence to FSMA preventive controls and promoting public health.

Utilizing FSMA Compliance Checklists

An FSMA compliance checklist provides a simple means of comparing your current compliance posture with the latest regulatory requirements. These checklists cover multiple aspects of FSMA regulations, including:

• Preventive controls
• Supplier verification
• Food defense
• Allergen mitigation
• Documentation requirements

Check out this free resource if you’d like to incorporate an FSMA compliance checklist into your risk mitigation strategy. There are several other downloadable PDF documents available, many of which are free to use. Take advantage of these tools to streamline your compliance process and improve adherence.

Addressing Common Challenges

Retooling your workflows and business processes can be daunting. However, you can mitigate the complexity of FSMA compliance by familiarizing yourself with the challenges that lie ahead.

One common difficulty that nearly all businesses encounter is resource constraints. Budgetary limitations, a lack of expertise, and time constraints can make it difficult to implement a compliance strategy.

Another common barrier is the complexity of FSMA requirements. The comprehensive act has different rules for each member of the food supply chain. Navigating these rules can be particularly difficult for small and medium-sized businesses with limited bandwidth.

Outdated or inadequate technology represents another challenge that you need to address head-on. Modern tracing tools can help you improve transparency and implement your food defense plan. A real-time tracking tool will also assist with labeling, product validation, and other aspects of FSMA compliance.

Training and Education

A well-trained and informed workforce is your greatest ally in the battle for FSMA compliance. Don’t just tell your staff what they need to do. Make sure they understand the “why” as well. Train them on compliance aspects, including the produce safety rule, recall plans, and general recordkeeping requirements. Also, remember to convey the implications of non-compliance.

There are dozens of great training resources out there. The FDA provides a wealth of information that you can use to educate your staff and empower their compliance efforts. Make sure to take advantage of third-party resources as well. At rfxcel, an Antares Vision Group, we have cultivated an extensive content library with timely, relevant information to help you stay up-to-date on the latest provisions.

Don’t stop with preliminary education on FSMA, though. Ensure that you are also training your staff on how to use new tools and processes to support compliance.

For instance, if you invest in new traceability technology, support the transition to these tools by providing extensive training. If your staff is confident with the tools, they are more likely to embrace change and use the technologies you’ve provided them.

Implementing Continuous Improvement

The regulatory framework is constantly evolving, so you must also evolve. Don’t treat FSMA compliance as a set-it-and-forget-it task. Instead, view it as an ongoing process that requires continuous improvement and innovation to ensure food safety and supply chain security.

You can begin to do so by routinely analyzing your compliance posture and identifying any shortcomings. Once you pinpoint weaknesses, proactively address them by refining your policies, procedures, and technology strategies. Taking a proactive approach will mitigate the risk of fines or other penalties and help you maintain consumer trust.

Case Studies and Success Stories

Examining how one small California farm successfully implemented an FSMA compliance strategy is helpful. The farm, New Native, produces microgreens, which the FDA classifies as a “high-risk” item. Due to its revenue, New Native is subject to full compliance requirements.

Fortunately, New Native and its leadership have been proactive about compliance since day one. As such, they passed their very first FSMA audit, which was conducted in early 2020. Since then, the company has maintained an impeccable record and a strong compliance posture.

Ken Kimes, co-owner and head of compliance for New Native, provided some great tips on preparing for audits. He emphasized the importance of having all documents organized and readily accessible to the auditor. Kimes also recommended making a great first impression, not over-answering any questions, and letting the inspector “drive” the process.

Strengthen Your Compliance Posture With rfxcel

Achieving and maintaining FSMA compliance requires a concerted effort from your entire team and buy-in from key stakeholders. Now that you know how to start FSMA compliance, it’s time to implement your plan by aligning your team, processes, and technologies.

With that in mind, we invite you to explore rfxcel solutions, a modern tracing solution designed for food supply chain members.

The Food and Drug Administration’s (FDA) Food Safety Modernization Act completely changed how food manufacturing supply chain members approach traceability. To keep pace with these changes and stay prepared for audits, you need modern food traceability software.

The question is, how do you find the right food traceability systems for your organization? Here’s everything you need to know.

Introduction to Food Traceability Software

Food safety traceability software refers to cloud-based solutions designed to help the food industry comply with FSMA traceability requirements. This tool can be used to manage inventory in real-time, store product information, and share insights with other supply chain members.

The best food safety traceability software also integrates with other business tools, such as barcode scanning equipment, to provide a holistic view of the flow of goods into and out of your inventory. Adopting a modern platform will help you better monitor the food supply chain, keep track of the raw materials used in food production, and promote consumer safety.

Most importantly, food safety traceability software solutions also streamline significant batch and unit tracking processes, saving time and reducing the risk of human error. Maintaining accurate and up-to-date records is foundational to achieving end-to-end traceability and ensuring compliance with FDA regulations.

Benefits of Food Traceability Software

Adopting the right software helps you centralize traceability data and streamline workflows. With a solution like rfxcel in your corner, you can achieve benefits such as:

Improved Transparency

The FSMA outlines strict record-keeping requirements designed to support expedited product recalls in the event of a foodborne illness outbreak. These provisions are also intended to increase consumer trust and ensure real-time visibility into where food products originated.

Food safety traceability software supports these objectives by integrating with other platforms, including your ERP system, and creating a holistic view of your supply chain. The best food traceability software offers value-added management features like lot tracking and recall management, giving you even better insights into your production process.

Simplified Compliance

Adopting robust software will assist with FSMA produce safety rule compliance. Solutions that offer customizable functionality can be tailored to the unique needs of food businesses, whether they be distributors, suppliers, or retailers.

You can track expiration dates, batch numbers, and more at a glance. Should you face an audit or encounter an outbreak, you can use this data to deliver prompt notifications to the FDA and any impacted retailers.

Optimized Visibility

Quality control requires end-to-end visibility into your supply chain. With a food traceability platform, you can implement custom quality assurance protocols and maintain a holistic view of your operations to ensure that those protocols are being followed. Ultimately, these capabilities will promote better supply chain management while enhancing consumer trust in your brand.

Increasing visibility will also support your company’s long-term health and success. You can use real-time insights to identify inefficiencies in your entire supply chain and improve inventory control strategies. By combining the information from your food safety traceability modules with data from your ERP software, you can transform your business into a flexible and resilient organization.

Enhancing Food Safety With Traceability

Food traceability software isn’t just great for regulatory compliance and supporting your stakeholders. It’s also an excellent tool for promoting safety. With robust software, you can achieve the following:

Streamline Recalls

Tracking down the origins of allergens and contaminants represents one of the toughest parts of issuing a recall. Historically, food manufacturers have been forced to “cast a wide net,” which can lead to unnecessary panic and tremendous product waste. However, with the help of food traceability software, you can issue more targeted recalls without compromising safety.

Accelerating the recall process will help curb the spread of food borne illnesses and minimize the risk of reputational damage. By quickly disseminating important information about affected products, you can also collaborate with retailers and the FDA.

Enforce Quality Control Standards

Quality management requires real-time visibility and accurate inventory records. The right tools enable you to monitor everything from when goods arrive to how long they sit at your warehouse. Increasing visibility will help improve freshness and reduce spoilage, both of which are great for your bottom line.

Mitigate Risks

Food safety traceability software is a risk mitigation tool. It allows you to safeguard your business, trade partners, and customers from the dangers of spoiled food or lax quality control processes.

By increasing your understanding of key workflows, you’ll achieve unprecedented oversight of business operations. This has become increasingly important amid supply chain disruptions and other uncertainties.

Key Features of Food Traceability Systems

Leading food traceability software offers numerous features, including the following:

Barcode Labeling

Labeling represents one of the fundamental requirements of the FSMA. You must label each unit and track goods as they progress through your segment of the supply chain. More importantly, you are required to maintain records of these transactions for auditing and quality control purposes.

Top software solutions collect and store this data, and the best platforms also streamline label creation.

Batch Tracking

The FDA has also implemented batch-tracking requirements. These help trace food from manufacturers to distributors and retailers. If a batch is contaminated, regulators will use this information to track down and recall products that may pose a consumer risk.

Solutions like rfxcel facilitate custom batch tracking. We allow you to track every shipment and maintain flawless digital records.

Real-Time Monitoring

Thanks to integrations with your ERP software, rfxcel’s food safety traceability solution offers real-time monitoring capabilities. You can track inbound and outbound shipments as they progress through the supply chain.

Reporting Tools

Creating a lean supply chain requires actionable insights. With that in mind, leading food safety traceability software includes robust reporting tools that provide both high-level and granular data about your business.

Technological Innovations in Traceability

Several advancements have accelerated the development of food safety traceability software, including blockchain and the Internet of Things (IoT). Blockchain provides a tool for creating accurate, immutable records of transactions, thereby ensuring transparency and trustworthiness. The IoT includes frontline internet-connected tools like barcode scanners and RFID devices.

Cumulatively, these tools have helped to promote a more nimble and reliable food tracing infrastructure. As you explore traceability solutions for your business, make sure to prioritize platforms that embrace these and other advancements.

Compliance and Regulatory Requirements

U.S. food traceability regulations primarily focus on items found on the FDA’s Food Traceability List. If you manufacture, process, hold, distribute, or pack any items on the FTL, the FSMA applies to your business.

Among other regulations, you must document critical tracking events (CTE) and retain key data elements about these occurrences. Some CTEs include harvesting, cooling, initial packing, and receiving. This is a partial list of requirements. You’ll need to review the entire FTL and FSMA final rule to understand your organization’s obligations under the act entirely.

Implementation Strategies and Best Practices

Successfully adopting food traceability software requires a three-stage approach. First, be transparent with your team about what’s happening and why you are implementing a new platform. Get them involved in the process early on to reduce change resistance.

As you begin the rollout, offer comprehensive training to ensure your team members are confident using the new tech. Put additional support staff in place to assist with any challenges that may arise and ensure that the technology can be scaled out across your entire supply chain.

Additionally, it’s crucial to consider compatibility with your existing technology, specifically your ERP software. Integrating your food tracing platform with your ERP will provide optimal efficiency and transparency.

Future Trends and Emerging Technologies

Emerging tech like artificial intelligence and predictive analytics will undoubtedly reshape the food supply chain. AI can automate key tracing protocols, save time, and promote better efficiency. Predictive analytics will shed light on threats to food safety and help you proactively mitigate them to reduce waste.

While you don’t have to be the first adopter of these and other emerging technologies, it’s important to keep your operations modernized and agile. Otherwise, you risk giving up ground to the competition.

Choosing the Right Traceability Solution

Generally, there are three factors to consider before selecting a food traceability software: customizability, vendor reputation, and scalability. The best platforms can be tailored to align with your unique needs. They also offer nearly limitless scalability by leveraging cloud-based infrastructure and a flexible architecture.

Perhaps most importantly, you need to find a vendor who understands the nuances of the Food Safety Modernization Act. Organizations like rfxcel specialize in helping our clients meet traceability regulations via dynamic, industry-specific solutions. When your organization’s future is on the line, rfxcel delivers.

Partner With rfxcel

Partnering with rfxcel today means joining a network dedicated to excellence in supply chain management. With our advanced solutions, you can ensure the highest standards of traceability and transparency. Would you like to learn more about the benefits and capabilities of food safety traceability software? Our experts are ready to demonstrate how our platform can enhance your operations. 

Contact us to book a demo and take the first step toward transforming your supply chain.

In the complex and tightly regulated world of pharmaceuticals, ensuring safety and traceability is paramount. The Drug Supply Chain Security Act (DSCSA) is a critical piece of legislation aimed at enhancing the security and traceability of pharmaceutical products throughout the supply chain. DSCSA exception handling represents a key component of this regulatory framework. It involves managing deviations from standard procedures to maintain the supply chain. In the following, you can explore the importance of DSCSA exception handling guidelines for maintaining the quality and safety of physical products in the pharmaceutical industry.

Key Concepts and Definitions

Before delving into the nuances of DSCSA 2023 provisions, examining some critical terms associated with this process is helpful. Exceptions refer to instances where deviations from standard procedures occur within the pharmaceutical supply chain. These deviations may include:

• Discrepancies in transaction information
• Product identifier records
• Chain of custody between distributors and dispensers
• Errors in transaction statements

Deviations are specific instances of exceptions that require investigation and resolution. In contrast, a waiver is an official exemption granted under certain circumstances that relieves you from specific DSCSA requirements.

Generally speaking, exception handling applies to all authorized trading partners — entities involved in the pharma supply chain — such as the following:

• Wholesale distributors
• Repackagers
• Third-party logistics providers
• Dispensers

The Food and Drug Administration (FDA) holds these entities accountable for adherence to the DSCSA and specific exception-handling guidelines.

Understanding DSCSA Exception Handling Guidelines

Throughout the DSCSA timeline, which featured a phased rollout of the regulatory framework, exception handling has remained a fundamental component of the act. The Healthcare Distribution Alliance (HDA) has helped affected entities keep pace with the latest changes and updates to exception handling by publishing a comprehensive list of guidelines.

These guidelines include processes for identifying, documenting, investigating, and resolving exceptions promptly. As part of your exception management strategy, you must maintain master data for prescription drugs. This database needs to include package-level product data as well as transaction data.

You can use this information to track the flow of goods along the supply chain and to identify discrepancies that deviate from your standard processes and workflows. Additionally, you are required to maintain accurate records of exception-handling activities, including investigation findings, corrective actions taken, and methods used to keep stakeholders in the loop.

For instance, you might identify a suspect product that may have been compromised. In that case, you will have to determine which pallets of goods were impacted and take appropriate action (e.g., initiate a recall or notify the FDA).

Compliance with DSCSA exception handling guidelines is essential. It allows you to uphold product traceability, prevent counterfeit products from entering the supply chain, and protect patient safety.

Types of Exceptions in Pharmaceutical Traceability

Within your pharmaceutical traceability framework, you may encounter several types of exceptions. Each situation requires a specific response.

For instance, product recalls necessitate immediate action to remove affected products from circulation and notify relevant stakeholders. Suspected counterfeit products must be reported and investigated thoroughly to ensure that they are not distributed to patients.

Discrepancies in product documentation, such as incorrect product identifiers or expiration dates, pose risks to your supply chain integrity and patient health. You must carefully investigate these exceptions to prevent misidentification and mitigate expiration risk.

Other slightly less severe exceptions may include shipping errors, packaging defects, and deviations from temperature control requirements. Though these issues are not as severe, they require prompt attention. You must also document any corrective actions that you took to remedy the problem.

Best Practices for Managing Exceptions

The DSCSA delay to late November 2024 has provided organizations with extra time to ensure compliance. However, this window is rapidly closing, so you must act now to capitalize on this added grace period, as the FDA is unlikely to offer another extension. Do you need help determining where to begin? We recommend implementing a few exception-handling best practices.

First and foremost, be proactive when communicating with stakeholders and trading partners. Reiterate the importance of rapid response and discuss ways to minimize exceptions’ impact on your supply chain. Establishing clear escalation procedures and designated points of contact will accelerate your resolution capabilities and lower the risk of response delays.

Moreover, it is crucial to create a detailed paper trail of your efforts. Whenever you encounter a discrepancy, you must protect the supply chain by documenting the scope of the problem and how you responded to it. Additionally, note the outcomes you achieved.

Thorough documentation enables your business to track the status of exceptions and identify trends or patterns. You can also use your records for auditing purposes and to help prevent minor issues from becoming more prominent, recurring problems.

Perhaps most importantly, you must collaborate with trading partners and regulatory agencies. Don’t view the DSCSA as a source of contention between supply chain members. Instead, acknowledge its intended purpose: to promote unity and optimize patient safety.

Implementing Exception Handling Processes

As you implement DSCSA exception-handling processes in your company, it’s crucial to establish open lines of communication between key stakeholders. Define clear roles and responsibilities for each entity. You and other organizational leaders should create procedures for identifying, categorizing, and prioritizing exceptions based on their severity and potential impact.

Next, develop a training strategy to promote a practical understanding of your policies and procedures. Conducting what-if scenarios can help your staff move from theoretical concepts to practical applications.

Investing in automation and other technology solutions can streamline exception management by facilitating real-time monitoring. With the right tools, you’ll gain actionable insights into deviations, enabling you to remedy them more effectively before they have a major impact on your operations.

Lastly, prioritize continuous evaluation and improvement. After you’ve met the minimum standards, explore ways to become more efficient at handling exceptions.

Ensuring Compliance With DSCSA Requirements

The FDA continues to provide updated guidance on DSCSA exception handling requirements. While the regulatory landscape is still evolving, a few ways exist to build a strong compliance posture and stay ahead of the learning curve.

Start by reevaluating your record-keeping and documentation strategies. Ensure that your team maintains detailed records of all exceptions and your response to these deviations.

Furthermore, conduct regular internal audits to assess your compliance status and identify areas for improvement. Taking compliance into your own hands will help you breeze through FDA audits and avoid regulatory penalties.

Additionally, adopting standardized processes for exception handling is vital. Creating and educating your team on a set of standardized responses enables you to promote consistency and efficiency in dealing with deviations from “business as usual.”

Collaborating with industry associations like the HDA can further strengthen your compliance posture and help promote alignment between your business and its trading partners.

Training and Education for Stakeholders

Implementing robust protocols and automation-centric technologies represents a huge step toward DSCSA compliance. However, the efficacy of these efforts hinges on your team’s knowledge and skills. With that in mind, investing in training and education for stakeholders is vital.

As you design your training programs, move beyond theoretical concepts and focus on practical applications. Explain what DSCSA exception handling is, why it matters, and how your team can contribute to a strong compliance posture. By teaching team members the “why” behind your initiative, you can promote better buy-in and increased adherence to the new policies.

Don’t rely on a single training delivery method, either. Instead, provide your staff with multiple educational resources, such as online courses, webinars, and in-person training, to maximize information retention.

Challenges and Considerations

Whether you have stayed apprised of the latest DSCSA regulatory requirements or are playing catch-up, you must familiarize yourself with the challenges you’ll likely encounter on your compliance journey. The biggest hurdle is change management.

Adopting new processes, technologies, and workflows is challenging for everyone. Therefore, it is essential to keep your team in the loop from day one.

Another common barrier to exception-handling compliance is the need for the right technologies and tools. You need end-to-end visibility into your supply chain to efficiently identify and remedy deficiencies in your compliance posture. Otherwise, significant problems may go unnoticed for weeks, resulting in reporting issues and compliance violations.

Partner with Rfxcel

Remedying this problem requires strategic technology investments. Focus on traceability solutions like rfxcel, an Antares Vision Group, which help you improve information visibility and accessibility. With rfxcel and other traceability tools, you’ll be able to rapidly identify and resolve any threats to business continuity while preserving the integrity of your supply chain.

Contact us today to see how our tailored solutions can help you!