Aris Global Software Pvt. Ltd.
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ALiCE 4 Labeling (A4L)

Product labeling is now recognized as a fundamental component of regulatory compliance. The introduction of XML into the labeling process has evolved to where, in the US, the FDA now accepts SPL (Structure Product Labeling) submissions in XML. SPL standards address the critical issue of inconsistency in labeling content.

Aris Global offers ALiCE 4 Labeling as an integrated option to our Register product. Alice 4 Labeling (A4L) is a best-of-breed XML based document authoring, collaboration and publishing environment developed by i4i, Inc., a world leader in the design and development of collaborative content solutions and technologies.

A4L provides a user-friendly digital dashboard to address the authoring and lifecycle management aspects of e-Label production. By integrating the i4i's A4L solution with Register , customers have a single, global solution for regulatory tracking and product labeling.

As with all Aris Global products, ALiCE 4 Labeling is available as a hosted solution on the agOnDemand platform. For more than four years, agOnDemand has been providing best-in-class, cloud-based services to life science companies to help them meet their regulatory requirements without the pressure of maintaining sophisticated IT infrastructures.

A Complete SPL Authoring, Management and Publishing Solution

  • Full implementation of the Physician's Labeling Rule, including highlights, coding, and recent major changes
  • Full document authoring and collaboration cycle, in the familiar Microsoft Word, to produce to produce XML documents that conform to the HL7 XML specification
  • Management of shared content fragments between SPLs and related documents such as USPIs, CCDSs and SPCs
  • Management of the 'side effects' of change between related documents
  • Project management using Microsoft Project
  • Process management & engineering consultancy services
  • Full support for:
    • All standard word processing capabilities
    • Section level editing
    • Document comparison
    • SPL

  • A4L Professional - Simplifying authoring of regulated documents with a powerful yet easy-to-use solution based on i4i's patented 100% Microsoft Word® authoring technology
  • No costly investments to train staff on XML conversion – it’s transparent to the user
  • At the push of a button a Microsoft Word® version of the SPL can be produced to support your internal review and publishing processes
  • Highlight sections are easily identified in the SPL/PLR compliant template and coding is simplified with SNOMED integration
  • No significant changes to your current infrastructure – leverage what you already have