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SPL documents can be exchanged across systems without the need for additional transformation steps. The ability to provide the most up-to-date product labeling in a timely manner is considered to be critical to improving risk management of regulated products. Facilitates more efficient evaluation of labeling changes by allowing more effective use of computer technology to compare different versions of labeling on a section by section basis. Promotes more coordinated data collection throughout the regulatory agency and improve processing, storage and archiving capabilities. Reduce or eliminate redundancies in data collection.
Improves access to information and enhance the ability to query and report on the content of labeling, allowing better support for specific analyses such as sub-population assessments of differences in products based on gender, race, age, and geographic location. Enhances patient safety by helping to provide prescribers and consumers with improved access to information needed to make better risk management decisions in a format that will enhance integration with other technical and clinical applications. CASE STUDIES See the Implementation Guide for this Standard. SPL documents are known as “product label,” “package insert,” “prescribing information,” “product information,” “medicines information,” and many other names. This specification includes a detailed description of an information model for structured product labeling documents as well as the XML representation of that model. M9 1a8 8 0 1 0 0 16A8 8 0 0 0 9 1zm. Join Stack Overflow to learn, share knowledge, and build your career.