Labeling Automation Solution for Drugs & Devices | LABELai - PowerPoint PPT Presentation

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Labeling Automation Solution for Drugs & Devices | LABELai

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DDi's LABELai is a patent-pending Labeling Automation Tool for end to end Regulatory Labeling Management. – PowerPoint PPT presentation

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Title: Labeling Automation Solution for Drugs & Devices | LABELai


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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.

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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 50countries
  • 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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