rfxadmin, Author at rfxcel.com

From Traceability Regulations Compliance to a Customized Service

Posted on September 13, 2023September 13, 2023 by rfxadmin

Collaboration between Ferring Pharmaceuticals and Antares Vision Group continues with a new testing and validation software and a better supply of spare parts.

Travagliato (Brescia), September 13, 2023. The collaboration, born in 2015, between Ferring Pharmaceuticals, a leader in reproductive medicine, maternal health, and specialist areas within gastroenterology and urology, and Antares Vision Group, a technological partner in digitalization of products and supply chains for companies and institutions, and a leader in traceability and inspection for quality control, continues. After an initial approach following the entry into force of the serialization regulations, Ferring Group currently uses Antares Vision Group solutions on 23 lines in plants in Switzerland, the United States, China, the Czech Republic, Israel, Scotland and Indonesia.

Thanks to the collaboration with Antares Vision Group, Ferring Group has significantly reduced procurement times for spare parts with integrated supply chain processes that always ensure the availability of the minimum quantity in stock, increasing the efficiency of maintenance operations. For spare parts, it is a reduction of over 90% in procurement times.

“This is one of the main benefits originating from the collaboration with Antares Vision Group started in 2015,” states Fernando Monteiro, Global OT Applications Senior Manager at Ferring Pharmaceuticals Group. “We went through challenging times in a growing serialization world. Regulations have been evolving over the years, impacting our production planning, sometimes making it more complex.”

Ferring Pharmaceuticals and Antares Vision Group have jointly developed customized solutions to improve maintenance operations. In particular, since many Ferring sites use the same components — which is convenient considering that having different spare parts at each site would be extremely costly — and a shortage of stocks would jeopardize business continuity, Antares Vision Group and Ferring have put in place a list of spare parts capable of covering the needs of the various plants involved. These components are in stock at the Antares Vision Group headquarters in Italy, available to be shipped worldwide at any time.

Due to the robust international agreement and exceptional collaboration between the two firms, Ferring Pharmaceuticals has seamlessly met specific requests, consistently ensuring adherence to the regulatory standards of every country they serve.

Furthermore, Ferring Pharmaceuticals has increased the level of efficiency of the production process during ordinary maintenance operations, not only by increasing the availability of spare parts, but also by adopting new solution for testing and qualifications to maintain operational continuity at the highest levels also in case of new releases and software updates.

To facilitate testing and qualification, a solution was developed that combines both hardware and software and replicates the functionality of Ferring’s production lines. This system can simulate operations in non-production settings such as offices and labs, making validation more accessible. Operating offline and without real packaging material, it enables comprehensive testing without disrupting actual production timelines.

“Our collaboration with Ferring Pharmaceuticals has evolved since the beginning following the needs and requirements of the customer,” concludes Mattia Assanelli, Service Director of Antares Vision Group. “By paying attention to regulatory developments and deepening the knowledge of the processes of the different Ferring sites, we have been able to improve production and maintenance efficiency, with a drastic reduction in spare parts procurement times and with a system that tests software updates, excluding the risk of line downtime.”

About Antares Vision Group
Antares Vision Group is driving digitalization of products and supply chains by leading traceability, inspection, and integrated data management. AV Group helps companies and institutions to achieve safety, quality, efficiency, and sustainability, enabling Trustparency®.

DIAMIND, AV Group’s integrated ecosystem of solutions, simplifies the technology environment and supports businesses growth by enabling a data-driven and tailored journey to digital innovation. Connecting physical products with digital identities, DIAMIND runs at the line, factory, warehouse, enterprise, and supply chain levels, and guarantees product quality (inspection systems and equipment) and end-to-end traceability (from raw materials to production, from distribution to the consumer and back) through integrated data management, applying artificial intelligence and potentially blockchain.

AV Group operates in the Life Science (pharmaceuticals, medical devices, and hospitals), Beverage, Food, Cosmetics, Chemicals, and Packaging industries and potentially many others.

AV Group has been listed in STAR segment of Euronext since 14 May 2021 and has been included in the Euronext Tech Leaders index, dedicated to leading tech companies with high growth potential, since July 2022.

In 2022, Antares Vision Group recorded a turnover of €223 million. The Group operates in 60 countries, employs more than 1,100 people, and has a consolidated network of over 40 international partners. www.antaresvisiongroup.com

About Ferring Pharmaceuticals
Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group committed to helping people around the world build families and live better lives. Headquartered in Saint-Prex, Switzerland, Ferring is a leader in reproductive medicine and maternal health, and in specialty areas within gastroenterology and urology. Ferring has been developing treatments for mothers and babies for over 50 years and has a portfolio covering treatments from conception to birth. Founded in 1950, privately-owned Ferring employs over 7,000 people worldwide. The company has operating subsidiaries in more than 50 countries and markets its products in over 100 countries.

Contacts for more information:

Raffaella Mora | PR Specialist Antares Vision Group
raffaella.mora@partner.antaresvision.com
+39 349 0709470

Press Office
Soluzione Group S.R.L. – Via F. Lana, 1 – 25020 Flero (BS) – Italy
T: +39 030 3539159
Giusy Martin | Cell. +39 3881681168
martin@soluzionegroup.com

Antares Vision S.p.A.
Via del Ferro, 16 – 25039 Travagliato (BS) – Italy
T: +39 030 7283500
info@antaresvision.com – www.antaresvisiongroup.com

Antares Vision Group, Through rfxcel Technology, Becomes the First DSCSA Solution Provider to Join NABP’s Pulse Interoperable Partner Program

Posted on August 29, 2023November 10, 2023 by rfxadmin

A pharmacist in a white lab coat scanning a box of prescription medicine

AV Group, which has a long history of working with the National Association of Boards of Pharmacy, extends its commitment to DSCSA compliance by joining the Partner Program.

Travagliato (Brescia), August 29, 2023. Antares Vision Group, an Italian multinational and a leading provider of track and trace and quality control systems, today announced that it has partnered with the National Association of Boards of Pharmacy^® (NABP^®) through the Pulse Interoperable Partner program. This new initiative aims to accelerate interoperability in the drug supply chain by providing a framework for solution providers to integrate directly with Pulse by NABP™, an inclusive, accessible, and secure digital platform that simplifies the process of achieving Drug Supply Chain Security Act (DSCSA) compliance.

Nearly 10 years ago, the DSCSA was enacted to ensure the safety of the U.S. pharmaceutical supply chain. The law, which has a deadline of November 2023, requires cooperation and interoperability among a wide range of industry stakeholders and solution providers. As the deadline approaches, these actors must continue to work together to ensure they will meet the complex requirements of the DSCSA.

NABP has been and will continue to be a key stakeholder in the DSCSA effort, representing the needs and interests of state regulators. This includes Pulse by NABP, which facilitates DSCSA compliance across the supply chain by providing additional functionality and data required to ensure seamless interoperability among participants. Antares Vision Group, through rfxcel technology, recognizes the importance of NABP’s contributions and is proud to be the first solution provider to sign up for this partner program.

“We have been working with the NABP for years and have watched their continued commitment to the DSCSA effort,” said rfxcel Senior Vice President of Product and Strategy Herb Wong. “Their involvement offers critical insight into the needs of the state boards of pharmacy and the small dispenser community and reflects the feedback that we’ve been hearing from our customers. We are excited to participate in the Pulse Interoperable Partner Program to ensure safe pharmaceuticals for patients and consumers.”

”Antares Vision Group became the first solution provider to be a Pulse Interoperable Partner, signing on within hours of the program being announced at NABP’s recent Interoperability Summit,” said NABP Executive Director/Secretary Lemrey “Al” Carter, PharmD, MS, RPh. “They have been an ardent supporter of Pulse and we’re delighted to continue the collaboration to secure the prescription drug supply chain and protect public health.”

For more information, contact Herb Wong, senior vice president of product and strategy, at hwong@rfxcel.com.

About Antares Vision Group

DIAMIND, AV Group’s integrated ecosystem of solutions, simplifies the technology environment and supports businesses’ growth by enabling a data-driven and tailored journey to digital innovation. Connecting physical products with digital identities, DIAMIND runs at the line, factory, warehouse, enterprise, and supply chain levels, and helps guarantee product quality (inspection systems and equipment) and end-to-end traceability (from raw materials to production, from distribution to the consumer and back) through integrated data management.

AV Group operates in the life science (pharmaceuticals, medical devices, and hospitals), beverage, food, cosmetics, chemicals, and packaging industries and potentially many others.

AV Group has been listed in STAR segment of Euronext since May 2021 and has been included in the Euronext Tech Leaders index, dedicated to leading tech companies with high growth potential, since July 2022.

In 2022, Antares Vision Group recorded a turnover of €223 million. The Group operates in 60 countries, employs more than 1,300 people, and has a consolidated network of over 40 international partners. To learn more, please visit antaresvisiongroup.com and rfxcel.com.

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.

Antares Vision Group, Through rfxcel Technology, Joins the Gateway Certified™ Program to Lead Verification Router Service (VRS) Standardized Testing Initiative

Posted on August 22, 2023November 28, 2023 by rfxadmin

Serialized boxes of medicine on a manufacturing line in a pharmaceutical production facility

AV Group, which led an FDA-approved pilot to extend testing of the VRS, continues its industry leadership by helping to test industry readiness ahead of this year’s DSCSA deadline.

Travagliato (Brescia), August 22, 2023. Antares Vision Group, an Italian multinational and a leading provider of track and trace and quality control systems, today announced that it has joined the Gateway Certified™ program for Verification Router Service (VRS) verification to help pharmaceutical stakeholders prepare for upcoming serialization and drug product verification requirements in the U.S. Drug Supply Chain Security Act (DSCSA).

The industry established the VRS specifications to help verify the authenticity of products for salable returns. Many providers have developed solutions based on the VRS specification and have voluntarily collaborated in testing to ensure compliance and interoperability.

The Gateway Certified™ program for VRS Verify was established in response to industry concerns that manual methods and self-testing among more than a dozen solution providers was time-consuming, was not scalable, and lacked independent oversight.

Recognizing the importance of connectivity and interoperability, Antares Vision Group, through rfxcel technology, is committed to independent and objective VRS verification testing. “We recognize that solution providers need a more scalable, repeatable, and open testing approach,” said rfxcel CEO Glenn Abood. “We see the limitations of the current approach and see the potential impact on robust, reliable systems as well as adaptation to emerging requirements.”

“We appreciate Antares Vision Group’s leadership and ongoing commitment to facilitate information interoperability and product verification in the pharmaceutical supply chain,” said Gary Lerner, President of Gateway Checker Corporation. “We encourage all solution providers interested in establishing demonstrable VRS conformance to join the Gateway Certified™ program.”

The Gateway Certified™ program provides independent, objective, automated use-case testing to assure that pharmaceutical drug product verification requests and responses consistently meet industry and FDA regulatory requirements. It examines a system’s conformance to requirements and provides objective evidence that it consistently meets industry and regulatory needs.

Herb Wong, rfxcel senior vice president of product and strategy, will be facilitating a Roundtable Discussion about the VRS at the Healthcare Distribution Alliance (HDA) 2023 Traceability Seminar in Washington, D.C. To learn more, click the image below and visit Antares Vision Group at Table-Top 21 at the seminar.

About Antares Vision Group

AV Group operates in the life science (pharmaceuticals, medical devices, and hospitals), beverage, food, cosmetics, chemicals, and packaging industries and potentially many others.

For further information, contact Herb Wong, senior vice president of product and strategy, at hwong@rfxcel.com.

About Gateway Checker Corporation

Gateway Checker™ provides a software as a service platform to facilitate product traceability, DSCSA compliance, and unambiguously verify the interoperability readiness of serialized pharmaceutical transaction records. Drug manufacturers, repackagers, wholesalers, and distributors can quickly and continuously test, validate, and certify adherence to GS1 US Rx EPCIS and VRS product verification application standards.

Gateway Checker is the GS1 US Rx Certified Conformance Testing Service, and is owned and operated by the Gateway Checker Corporation, a wholly owned subsidiary of BrandSure, LLC.

For more information about the Gateway Certified™ program, including VRS System Validation, contact Eran Strod at certified@gatewaychecker.com.

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

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

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

Understanding the FDA Food Safety Modernization Act (FSMA)

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

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

7 FSMA rules and requirements

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

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

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

Compliance strategies for FSMA

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

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

Implementing FSMA’s Preventive Controls and Hazard Analysis

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

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

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

Ensuring FSMA compliance in supply chain management

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

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

Final thoughts: FSMA rules and regulations

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

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

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

The Importance of Food Traceability: Impacts on Safety and Business

Posted on August 7, 2023 by rfxadmin

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

Understanding food traceability

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

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

Benefits of food traceability

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

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

Key elements of food traceability

The primary components of a good food traceability system include:

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

Implementing food traceability systems

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

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

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

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

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

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

What food products are required to be traced under FSMA?

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

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

Final thoughts: food traceability

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

Antares Vision Group Attains ISO/IEC 27001 Cybersecurity Certification for Serialization and Global Regulatory Compliance

Posted on July 11, 2023August 22, 2023 by rfxadmin

Obtained through rfxcel, the information security management systems certification demonstrates the Group’s ability to protect and manage customers’ data on a global scale, complementing rfxcel’s ISO 9001 certification.

Travagliato (Brescia), July 11, 2023. Antares Vision Group (EXM, AV:IM), a leading provider of track and trace and quality control systems, through rfxcel’s San Ramon location, has attained ISO/IEC 27001 certification for information security management systems (ISMS), an important and significant achievement in the supply chain software solutions industry.

The certification demonstrates rfxcel’s incorporation of best-in-class technologies and best practices to preserve the confidentiality, integrity, and availability of customer data while proactively managing risks. As customers globally share serialization and other supply chain data, their needs for security, system controls, and governance grows. rfxcel’s continuous advancements within its controls and technology help customers comply with international security standards and regulations.

rfxcel Vice President of Global Quality Management Amit Sewak said the certification is a clear statement. “It means we are committed to protecting our clients from global security threats. We have an incredible organization that is focused on developing and delivering secure solutions that focus on our customers’ needs and the complex regulatory landscape they function within.”

Sewak added that the ISO/IEC 27001 certification confirms that the structure of rfxcel’s Quality Management System and ISMS exemplifies compliance internationally. “Regardless of the regulatory standards that clients function within, rfxcel is prepared today and for the future,” he said.

Glenn Abood, CEO of rfxcel, said the certification should give customers peace of mind about working with Antares Vision Group. “We have strategies to manage the performance, quality, and effectiveness of our products and services,” he explained. “Our customers have the assurance that their data is strictly controlled, stored, and protected.”

In addition to the ISO/IEC 27001 certification, rfxcel’s existing ISO 9001 certification conveys its commitment to customers and continual improvement. “Our customers know our management systems and architecture are efficient. They know we perform at a high level and use leading technologies to support them,” Sewak said.

For more information, contact rfxcel Senior Communications and Content Manager Garrison Spik at garrison@rfxcel.com.

About Antares Vision Group

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

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

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

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

Understanding Supply Chain Visibility

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

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

Increase efficiency
Ensure customer satisfaction
Inform decision-making
Improve sustainability

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

Benefits of Supply Chain Visibility

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

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

Key Components of Supply Chain Visibility

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

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

Implementing Supply Chain Visibility

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

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

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

Best Practices for Supply Chain Visibility

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

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

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

Overcoming Challenges in Supply Chain Visibility

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

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

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

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

The Future of Supply Chain Visibility

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

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

We’ll Help You Achieve Supply Chain Visibility

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

Pharmaceuticals
Food
Beverage
Consumer goods
Government

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

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

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

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

Understanding Supply Chain Visibility Tools

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

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

Benefits of Supply Chain Visibility Tools

Implementing supply chain traceability software offers many benefits:

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

Key Features of Supply Chain Visibility Software and Tools

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

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

Implementing Supply Chain Visibility Solutions

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

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

Best Practices for Utilizing Supply Chain Visibility Tools

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

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

Ensuring Data Security and Privacy in Supply Chain Visibility

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

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

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

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

Find the Best Supply Chain Visibility Software

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

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

Compliance Management Solutions: Ensuring Regulatory Compliance and Risk Mitigation

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

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

Understanding Compliance Management Solutions

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

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

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

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

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

Benefits of Compliance Management Solutions

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

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

Key Features of Compliance Management Solutions

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

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

Implementing Compliance Management Solutions

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

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

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

Best Practices for Effective Compliance Management

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

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

Ensuring Data Security and Privacy Compliance

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

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

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

The Future of Compliance Management Solutions

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

Choose Us for Expert Compliance Management

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

To get started or request pricing, contact us today.