Ease of Content Migration
Migration of existing content is fast and easy. Content can be
authored directly in the SPL templates, imported (Word .docx or XML files) into A4L, or copied and pasted from other sources. Even the most complex content, such as tables and graphics, are copied with ease into A4L.
The Physician’s Labeling Rule
A Physician’s Labeling Rule (PLR) format SPL can be easily created from scratch,
or upgraded from an existing non-PLR document. Standardized sections and
boiler-plate text are automatically generated, and Highlights are uniquely arranged
to ensure content compliance with the related section's text. When converting a
non-PLR label to the PLR format, A4L automatically reorders sections and guides
the user in the necessary content revisions to ensure compliance.
Automated Code Management
A4L automatically handles everything involving the management of the GUIDs (Globally Unique Identifiers),
XML attributes, Ingredient Codes (UNIIs), and coding associated with the FDA's
controlled vocabulary. A4L takes all technical
complexities out of the SPL process, allowing authors to focus on the content while
easily creating valid and compliant submissions.
Compliant Drug Listing
A4L features user-friendly forms that guide the user through the definition and
population of all required drug listing information. Its unique FDA Resource Updater
ensures the extensive lists of FDA-controlled vocabulary, within the A4L interface,
remain current as changes are made by the FDA.