Labeling Digitization: Manage Data, not Documents

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Labeling Digitization Manage Data, not Documents

• A prescription drug product label is a
  compilation of information about the safe and
  effective use of the product prepared by the
  manufacturer or marketing authorizing holder
  (MAH) and approved by the health authorities in
  the respective marketed zones. Drug labeling is
  becoming more prominent that involves dealing
  with multiple functional dynamics with required
  specialized attention, stakeholders (supply
  chains), and constantly evolving regulatory
  environment across the globe. Marketing
  authorization holder is responsible to maintain
  the valid and updated information in their
  approved or marketed product labels throughout of
  its lifecycle globally where the products are
  being marketed.

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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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