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The year 2005 marked the formal introduction of XML into the labeling process.
In the EU the EMEA European Agency for the Evaluation of Medicinal Products is accepting PIM (Product Information Management) compliant documents. Applicants will no longer submit paper or Word documents for product information.
In the US the FDA (Food and Drug Administration) is now accepting SPL (Structured Product Labeling) submissions in XML. In order to gain regulatory approval, SPLs have to be submitted in an XML format specified by the HL7 SPL working group.
i4i is pleased to offer the complete e-Labeling document authoring, life-cycle management and publishing solution. The i4i solution, ALiCE 4 Labeling (A4L) addresses all aspects of e-Label production and supports the following:
- Full document authoring and collaboration cycle, in the familiar Microsoft Word, to produce to produce XML documents that conform to the EMEA PIM and the FDA SPL specifications.
- Support for QRD (SmPC, PL, Blister, AnnexII, Immediate, Outer, and Component) documents in XML following the EMEA PIM guidelines.
- Support for internal labeling documents such as; Labeling Monographs, CCDS, CPI...
- Cross document content verification and validation using a Master Labeling Document.
- Managed content interoperability between all document classes supported in by A4L.
- Sharing and management of reusable content fragments between MLDs, SPLs, PIMs and QRDs.
- Control over of multi-lingual QRD and other documents.
- Reporting on the 'side effects' of change between related documents.
- Publishing of PIM and SPL documents in conformance with regulatory guidelines.
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