CDC targets track and trace
The complex and globalised pharma supply chain creates potential quality control and safety issues and regulators, plus companies, are keen to minimise the threat.
CDC believes its Trace Express Viewer, an addition to its Ross ERP (enterprise resource planning) Lot Trace application, can help users tackle these problems by tracking active pharmaceutical ingredients (API), intermediates and finished products.
The system can track these materials through receipt, manufacture, inventory, sales and delivery. CDC claims that the system is “highly intuitive” and that this cuts the time it takes the user to identify, review and process data related to a particular lot throughout the supply chain.
Users managing their materials, manufacturing and financials using the system will be in compliance with cGxP (current good clinical/laboratory/manufacturing practices).
Furthermore Ross ERP and Trace Express allow users to provide an ePedigree for a drug if requested by an inspector. This details a product’s movements through the supply chain to provide evidence of its quality and legitimacy.
The next step
Trace Express is the first of two products developed by CDC focused on safety and quality control. A time frame for the launch of the second system has not been released.
CDC claims to have developed the two systems in record time, with Trace Express taking half as long as products that it built using the traditional waterfall development model.
This has been achieved by using a “development methodology based on highly collaborative and iterative processes”, according to Alan MacLamroc, chief product and technology officer of CDC, who added that it represents a significant improvement.
CDC plans on applying this methodology to other products in development to shorten the time taken to reach the market.
