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ALiCE for Labeling - The Complete European Labeling Solution

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The Challenges:

Life Sciences organisations are not short of challenges, but when it comes to managing product labeling content some of the more prevalent challenges remain:

  • Time to market in competitive industry
  • Maintaining compliance with the evolving rules and guidance of regulatory agencies
  • Content consistency in managing same and similar content across multiple documents and uses
  • Management of labeling content [minimize time investment, improve consistency, increase efficiency]

The Solution:

i4i's EU Labeling Solution [A4L - ALiCE for Labeling] helps to address these challenges with a metadata rich structured content authoring and lifecycle management model. A4L allows you to easily manage the complete set of global labeling content and create compliant QRD files ready for submission to the Health Authority.

Our EU Labeling Solution is the result of the customization and optimization of i4i's ALiCE technology. ALiCE supports our flagship x4o authoring solution with a suite of modules that deliver boundless possibilities for managing the creation and lifecycle of all your content.

ALiCE web services

Overview of the EU Labeling Solution Modules

With a focus on the narrative authoring approach, our structured authoring platform is flexible in providing the mechanism for authoring at the section or fragment [topic] level, all integrated with our sophisticated reuse model.

From creation, through review and revisions, to translation, to publish - A4L offers unique features that maximize the efficiency and consistency of the labeling process in ways that ultimately result in better label content.

The EU Labeling Solution is enhanced by the inclusion of your corporate product documents like the CCDS

 

 

EU Quality Review of Documents [QRD]: Key Benefits & Features

  • Product Definition and Information: Based on a single authoritative view of a product's details
  • Product definition - application & submission management
  • Product table - manage ALL product information

  • Authoring, Reuse, Translation:
  • Master QRD - offer a sophisticated reuse and applicability model, driving consistency
  • Generate specific QRD - for review, approval and publish
  • Translation management - duplicate content translated once, minimizing time & cost

  • Publishing & Submission:
  • Readiness report
  • Validation
  • EMA Product Information - QRD submission


 New & evolving: Leveraging existing XEVMPD data & SmPC product information for the IDMP standard

 

Corporate: Company Core Data Sheet [CCDS]

The EU Labeling solution is designed to meet your specific needs - advantages for consistency and efficiency are realized when the CCDS is included in the configuration.

Some of the key benefits of our CCDS dashboard include:

  • Identification of key information:
  • Mandatory text
  • Safety text
  • Explicit content deletion/insertion

  • Publishing of:
  • Clean CCDS
  • Mandatory text
  • Safety information
  • Change history
  • CCDS compliance form

  • CCDS follow-up process:
  • Distribution to local subsidiaries
  • Monitoring local implementation/acceptance

DOWNLOAD OUR ALiCE FOR LABELING DATASHEET FOR MORE DETAILS