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SPLs (Structured Product Labels) must be submitted in an XML format specified by the HL7 SPL working group and formally supported by the FDA (Food and Drug Administration), and labels for new and recently approved products must also follow the Physician's Labeling Rule.
i4i is pleased to offer the complete SPL document authoring, management and publishing solution. The i4i solution, 'ALiCE 4 Labeling' (A4L), addresses all aspects of SPL production and supports the following:
- Full implementation of the Physician's Labeling Rule, including highlights, coding, and recent major changes.
- Full document authoring and collaboration cycle, in familiar Microsoft Word, 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
Based on ALiCE (i4i's Authoring Lifecycle Collaboration Environment), and x4o, A4L extends the value proposition of your existing IT infrastructure to deliver a complete SPL solution.
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