Global UDI Database: What Verification or Validation Does FDA Need?

There aren’t any validation activities beyond what the database is doing inherently or through business rules.  There is no formal review of device data by FDA auditors or inspectors.  FDA does have a team of data quality experts who examine whether the instructions are clear and ensure data is coming into the database in a consistent manner.  Ultimately, FDA employees are looking to make sure the database is operating correctly.

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.