REGULATORY

 

(Patent-Pending) Next Generation Labeling Automation Solution

LABELai is a patent-pending tool that ensures top-down approach linking content and operations seamlessly. This system utilizes Artificial Intelligence and NLP business rules internally coupled with local country regulatory requirements and all of this delivered in a cloud platform to reduce IT burden drastically. In turn, all local label compliance managed automatically without manual efforts. With the use of an automated process, labeling teams can reduce time, costs and non-compliance challenges.

  • 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)
Global Compliance of Labeling Automation

Facilitates Global Compliance of Labeling

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. It has label compliance functionality to perform label compliance checks against CCDS documents. If any compliance issues, system generates alerts for each Label version at each section level.

Quality and Cost Benefits

The automated processes produce consistent and quality labels that promote the accuracy required to maintain patient safety as well as label data integrity. With a reduction in manual intervention, QC or Review efforts will be reduced drastically. Overall, local labeling content management productivity increases when using LABELai. Label changes can be managed much more quickly, saving a significant amount of time for companies.

Key Benefits:

  • Built-in Change control & implementation full cycle
  • Reduce process and content errors at every stage (literally, no QC needed for local labels)
  • Maintain absolute compliance
  • Inbuilt global labeling regulatory intelligence
  • Deep Cost savings

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