Dedicated to developing interoperable technical guidance and ISO standards.
 
February 23, 2021 – Pittsburgh, PA – AIM North America (AIM NA), the premier alliance for the automated data capture technologies industry, including barcode, RFID, IoT, NFC, and RTLS, submits comments on the FDA’s Requirements for Additional Traceability Records for Certain Foods.
 
These comments stem from the increasingly globalized, complex supply chains that have resulted in less visibility into food sourcing for customers and regulators.  These trends are driving the need for digital transformation through the adoption of technology to bring automation, integrity, and data management solutions to supply chain traceability. 
 
“Digital technology can enhance the ability to identify, respond to, and prevent food safety issues such as outbreaks,” stated Jeanne Duckett, who serves as the AIM NA Food Supply Chain work group Chair, along with her role at Avery Dennison in Transparency Initiative Development. “Given recent food incidents, the use of digital technology has become even more needed, as it can help to make full product data accessible throughout every stage of the food supply chain in the event of a recall” Duckett continued.
 
The proposed rule, “Requirements for Additional Traceability Records for Certain Foods” (Food Traceability Proposed Rule) is a key component of the FDA’s New Era of Smarter Food Safety Blueprint and would implement Section 204(d) of the FDA Food Safety Modernization Act (FSMA).
This is excellent step on the part of the FDA to quickly implement source traceability, trace forward and implementing targeted recalls.
 
AIM NA’s comments noted the following key points:

1. Leverage on the work that FDA has already done with other consensus-based standards groups such UDI and DSCSA.
2. Use Globally Unique Identifier contained in a Data Carrier (i.e., 2D Barcode, RFID, NFC, digital watermark, etc.) attached to item and captured automatically at defined points.
3. Focus on permissioned access to data throughout the supply chain to end consumers.
4. Terms –importance of aligning on definitions for commonly used terms to promote the common understanding. 
5. Food Traceability List clarification
6. Clearly defining product recall. 

“AIM NA and our members are committed to advancing food safety utilizing new and emerging AIDC technologies that enable end-to-end traceability for the safest possible food supply chain,” shared Debangana Mukherjee, AIM North America Chair and Director of Business Development & Sales at CISC Semiconductor.
  
Read our final comments and contact AIM NA with any questions. 

AIM North America member experts share expertise as a resource to direct and guide organizations of asset tracking technologies for vaccine distribution traceability.
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February 22, 2021 – Pittsburgh, PA – The United States and other countries around the world are undertaking one of the largest, if not the largest, logistics endeavors in history. In the US alone, planning for the distribution of more than 300 million COVID-19 vaccine doses is currently underway. The implementation of asset tracking and product authentication AIDC (Automatic Identification Data Capture) technologies including barcode, RFID, IoT, RAIN, RTLS, NFC, provide increased quality control, visibility, and accuracy of the vaccine at all points along the supply chain, from manufacturer to patient.
 
Active battery powered and passive battery-less AIDC technologies enable temperature, location and damaging shock or vibration information to be monitored by vendors in real-time.  AIM North America (NA) has announced that they provide expertise in advising organizations on the best way to ensure the authenticity and traceability of all pharmaceutical products.
 
The US FDA Drug Supply Chain Security Act (DSCSA) seeks to protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated or otherwise compromised and potentially harmful. Serialized barcodes serve as a foundation for traceability within the channel.  AIDC technology connects the multi-faceted elements or information furthering the validation and serves as a building block for interoperability.  In combination these platforms provide full traceability of each transaction and change of ownership throughout the lifespan of the product, ensuring its safe use to the patient.
 
 “As a manufacturer of pressure sensitive materials used in labeling and packaging pharmaceuticals, we understand the necessity for tracking and tracing product from the manufacturer, through the supply chain, and to administering of the drug to the patient.  The work of the FDA Drug Supply Chain is critically important, and AIM NA and its members can provide the industry with knowledge, structure and guidance,” stated Lori Bitar, Chair, AIM NA Pharmaceutical Work Group and Market Development Manager, Pharmaceutical and Medical Device Labeling at FLEXcon.
 
AIM North America Chair and Director Business Development & Sales at CISC Semiconductor, Debangana Mukherjee, added “AIM North America members are poised to provide insight and expertise to assist the pharmaceutical industry in addressing the challenges they face until DSCSA 2023.” She continued, “Relying on global, interoperable consensus-based standards is foundational for improving processes and efficiencies within the supply chain.”
 
For more information on how you can start the conversation today, be sure to fill out our form and read through the AIM NA Digital Supply Chain Whitepaper.