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DDi's LABELai is a patent-pending Labeling Automation Tool for end to end Regulatory Labeling Management.
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Labeling Automation Solution for Drugs & Devices LABELai is a patent-pending tool that enables companies achieve their End-to-End labeling goals. With option of using the system for either Content Management or Label Operations or both, companies can pick the part of the tool that enhances their productivity and compliance. LABELai provides end-to-end support for labeling such as CCDS create/update, SmPC/USPI create/update, LPD create/update using inbuilt country specific regulations, artwork processes, local country operations, and supply chain release aspect. If any compliance issues, system generates alerts for each Label version at each section level.
Some Key Features of LABELai • Company Core Data Sheet (CCDS) & IFU - creation and maintenance • Local Labels generated automatically from any of master document CCDS, IFU, SPC and USPI documents • Regulatory Intelligence built-in for 50+countries • SPL creation and updating • Full manual/machine translation built-in • Compliance check for local label deviations and local deviation safety compliance • E2E Tracking with Change control and Label Operations • Built-in EDMS (or can integrate to yours) and BPM (for workflows)
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