A4L: The Complete SPL Solution
SPL (Structured Product Labeling) is an XML format specified by the HL7 SPL working group and formally supported by the FDA (Food and Drug Administration).
The FDA requires all drug product content of labeling, drug listing, and establishment and registration information to be submitted in the SPL format. This initiative continues to expand and also includes Medical Devices and biologics Lot Distribution Reports. You can read more about the latest SPL Guidance updates here.
Since 2004, i4i has been a key member of the SPL Working Group, where we have used our XML knowledge and
industry expertise to support the FDA’s SPL initiative. We remain committed to delivering comprehensive and easy-to-use
structured authoring and content management solutions, that are first to market and best-in-class to comply with FDA standards.
To that end, our comprehensive A4L solution has been successfully deployed at over 90 pharmaceutical
A4L addresses all aspects of SPL production, including full implementation of the Physician's
A4L provides a full structured document authoring and collaboration cycle, in the familiar Microsoft Word, to
produce XML documents that conform to the SPL specification.
A4L extends the value proposition of your existing IT infrastructure to deliver a complete SPL
A4L is delivered in the following configurations:
- A4L PROFESSIONAL (single-user desktop version) more...
- ALiCE for Labeling - US SPL Edition (multi-user server version with full collaboration capabilities) more...
As an XML pioneer and leading contributor to the development of the SPL standard, i4i possesses an intricate
understanding of the FDA requirements. SPL DIRECT can assist in any part of the SPL
creation and submission process, ranging from full outsourcing to in-house ad-hoc conversions.
i4i has assisted in the SPL creation and submission process for a wide range of clients around the globe, resulting in 1000's of valid SPL submissions, to date.
For more details on i4i's SPL DIRECT, click here.