The guidance does mention creating a system for manufacturers to respond to verification requests. But, there is no specific mention of what “system” means. System may simply mean standard operating procedures or business processes. To be clear, it does not necessarily mean ‘computerized system’. The verification process in the short term may look like the processes used to fulfill the Florida ePedigree requirements. In those situations, the verification process involves phone support from the manufacturer, and the manufacturer has an internal capability to access information quickly without relying on an IT analyst to create and generate report data.
The USDM Life Sciences Track & Trace Solutions and Services team will help you assess, plan and execute the changes and enhancements necessary to meet these regulations. Our team of experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM’s assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to foreign medical agency databases for pharmaceutical tracking. Also, USDM experts ensure that all changes and enhancements are implemented under the governing GMP regulations, under change control and validated prior to release for production.