30 Route 18 | Suite 1 | Old Bridge NJ 08857 | Tel: 732.679.2200
INSIGHTS IN AUTOMATION
Traceability By Any Other Name
Call it what you will – serialization, UDI (unique [medical] device identification), anti-diversion coding, track and trace – the unique identification of product is being addressed by our customers. We understand that integrating data to create a unique traceable identifier on your product is a very real concern.
Where is traceability having an impact?
• Serialization, for the DSCSA (the FDA’s Drug Supply Chain Security Act)
• Anti-Diversion, for the retail distribution of your high-value or high-margin products
• UDI or Unique [Medical] Device Identification, for the GUDID (Global Unique Device Identifier Database)
• Better communication between your manufacturing processes and your enterprise IT efforts.
The goal of traceability in industries governed by federal regulations is to ensure that the final consumer does not acquire a counterfeit product. In the pharmaceutical industry, traceability is called serialization. Its precursor was called track and trace. In the medical device industry, traceability is called UDI or unique device identification.
For industries making efforts to control diversion of their product to unauthorized retail channels, traceability is referred to as anti-diversion coding.
Primary Systems has worked closely with a number of clients to develop and program the information and control systems needed to take the first steps towards complete traceability:
• Change or update their code reading equipment, adding cameras and sensors, or implementing data points/tags to their database
• Provide programming and coding support to extract master data from enterprise resources in order to create a unique (when relevant, government mandated) number or code
• Create a unique serialized product code for both 2D bar-codes and human readable codes to be applied to each unit
• Integrate the controls and information systems for the labeling, vision and sensing equipment to capture the new serial number in order to verify accuracy and support validation
• Upload the verified data for the management of the serial numbers, which will be sent along the supply chain and
• Configure reports and trending so this data can be accessible and functional at many organizational levels
If you are moving in any of these directions – due to federal regulations or corporate strategy - ensuring supply chain security will require new solutions at the machine, line, plant and enterprise levels.
Let us help with your data flow.
Our Solutions provide a bridge between Manufacturing and IT.