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ALiCE - The Complete Global 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 a competitive industry
  • Maintaining compliance with the evolving rules and guidance of the Health Authorities
  • 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 Global Labeling Solution helps to address these challenges with a metadata-rich structured content authoring and lifecycle management model. ALiCE allows you to easily manage a complete set of global labeling content and create compliant files ready for submission to the appropriate Health Authority.

ALiCE's rich metadata, advanced workflow engine, and process management dashboards allow complete content tracking for the lifecycle of document change processes. The who, what, when & why, etc. about all activity for a given process can be captured and therefore tracked. The level of granularity is determined by your organizational requirements.

Our global 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 ALiCE 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 - ALiCE offers unique features that maximize the efficiency and consistency of the labeling process in ways that ultimately result in better label content.


Corporate: Company Core Data Sheet [CCDS]

Beginning with the CCDS, the global labeling solution is designed to meet your specific needs - providing advantages for consistency and efficiency across all jurisdictions.

Local labels, such as USPI (SPL) or SmPC, and compliance forms are linked to the CCDS, allowing centralized maintenance of global regulatory material for the pharmaceutical product. In applicable situations content re-use models can be leveraged to help maintain consistency and efficiency.

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

Single Document Module: Structured Product Labeling (SPL)

Single document drug product submission modules are found in Canada, Japan and the United States. The SPL being one such example.

i4i is the world leader in providing SPL solutions. It has, since the beginning of SPL in 2004, worked with the FDA and industry on developing the SPL specification and building software to realize its implementation.

Structured templates are available to author the over 40 SPL submission types, including establishment registration, product labeling documents, medical devices and lot distribution. Content such as product data elements and establishments can be edited through specialized wizards with the web-browser interface and can be reused in multiple documents. Our SPL solution allows authors to instantly validate SPL documents against FDA requirements and generate SPL–compliant submissions.

Multi Document Module: EU Labeling Services

Multi document drug product submission modules are found in jurisdications such as the EU and the EMEA.

The creation of the document sets required by the EMA is fully supported in ALiCE. A product definition is created to start the EU labeling process, which is used to automatically generate the required Quality of Review Documents (QRD), such as the SmPC and PL. Document variables are managed separately from the QRDs, which allows a consistent vocabulary between documents. Intelligent reuse and applicability models keep redundancy in authoring and translations to a minimum.

Common Data Services: Identification of Medicinal Product (IDMP)

ALiCE also provides services to manage IDMP data for EU submissions within your product or QRD documents, such as the SmPC. This data can be identified for extraction from existing documents, or marked up during the authoring process. Reports showing the available IDMP data can be generated to evaluate the completeness of an IDMP submission.
**IDMP will continue to evolve as Health Authorities begin to adopt the standards.