FDA Materials Tracking and Traceability Compliance

KnarrTek provides the software, services and expertise to enable its clients to comply with FDA product-safety materials tracking and traceability requirements, in a wide variety of applications, including:

• Food, beverages and natural supplements

• Medical supplies and instruments

• Pharmaceutical Drugs

• Blood and DNA products

• Cosmetics, suntan lotion and similar skin-applied products

• Materials used in the manufacture

Almost all of these now require compliance with a variety of GS1 standards for barcode labeling, RFID tagging, materials traceability data capture, and supply chain information sharing.

Complying with these standards, as well as the related FDA guidance documents, is a complex process, especially for smaller organizations.

KnarrTek provides the expertise to enable small to mid-size organizations to comply with these requirements, backup up by affordable software to enable FDA/GS1 compliance, while minimizing the cost of labor required for data capture and sharing.

In implementing materials tracking and traceability solutions for its clients, KnarrTek uses two software platforms:

• BellHawk, which is a GS1 compliant barcode and RFID data collection, GS1 compliant barcode labeling, and materials tracking and traceability software platform. This platform is CFR21 Part 11 compliant and so can be used in a wide-range of FDA compliant applications including in medical and clinic settings.
• MilramX, which is a GS1 compatible information sharing, supply-chain data integration, and decision support platform. In FDA regulated applications, this is primarily used to exchange materials tracking traceability data with supply chain trading partners.

These platforms typically provide over 90% of the needed code for any specific application and enable KnarrTek to quickly and cost-effectively deliver FDA compliant applications.

The BellHawk software makes extensive use of Container based Tracking, including the use of the GS1 barcode and RFID standards to ensure electronic traceability of all foods, drugs, and other materials. The accurate generation of these labels and identification tags is performed automatically by KnarrTek's TAG software, thereby ensuring compliance with the FDA's traceability requirements.

Please click here to learn more about:

• KnarrTek Materials Tracking and Traceability Solutions
• Pharmaceutical Applications of the BellHawk Software
•  Food Safety Applications of BellHawk Software
• Medical Applications of the BellHawk Software
• Biotechnology and Laboratory Applications of BellHawk