FDA Compliance Applications of KnarrTek Software

The FDA now regulates over 25% of all goods sold at retail in the USA. This includes:

• Foods, Beverages and Natural Supplements

• Medical Instruments

• Pharmaceutical Drugs

• Biologics

• Food Containers

• Blood and DNA products

• Anything that comes into contact with the human body, such as bandages or suntan lotion.

• Anything used in the manufacture or packaging of any of the above items

Manufacturers of these FDA regulated products are required to maintain materials traceability records as to what materials went into their products by source and lot number. In addition many of the finished products are required to carry serial numbers or at the very least have to be lot controlled.

This is so that if people start to get sick or injured, the source of the contamination or defects can be quickly identified and products recalled before anyone else gets sick or injured.

One of the strengths of the KnarrTek software is its ability to capture materials traceability data. This enables instantaneous trace-back from a problem to all the potential sources of the problem including supplier materials, people, equipment, or QC testing. It also enables a trace forward from the source of the problem to all the customers to whom the affected products have been shipped.

The KnarrTek software makes extensive use of Container based Tracking, including the use of the UCC/EAN barcode standards and the emerging RFID ISO 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 software, thereby ensuring compliance with the FDA's traceability requirements.

Please click here to learn more about the Food Safety Applications of BellHawk Software

Please click here to learn more about the Medical Applications of the BellHawk Software