Stand-alone software must comply with the FDA’s UDI Final Rule. But, there are special requirements for stand-alone software distributed virtually because there isn’t a package where a UDI label can be placed. The UDI data must be in plain text on a “help” or “about” screen. Software distributed on a CD, DVD or USB flash drive must have a UDI on the label of the device.
USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet UDI regulations. Our team of UDI 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 the GUDID.
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