i4i's Latest A4L Professional Version 4.2 Incorporates Automatic Support of FDA Updates

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i4i Inc., a world leader in the design and development of .collaborative content solutions and technologies for life sciences announced the release of A4L Version 4.2 today. This release incorporates updates to the FDA controlled vocabularies and additional validation lists, and moves the application beyond the desktop as it incorporates more automatic functionality.

i4i Inc., a world leader in the design and development of collaborative content solutions and technologies for life sciences announced the release of A4L Version 4.2 today. This release incorporates updates to the FDA controlled vocabularies and additional validation lists, and moves the application beyond the desktop as it incorporates more automatic functionality.

This automatic functionality allows Life Science enterprises to author, submit, validate and manage their labeling process using the more current ingredient and other controlled vocabulary lists. Depending on the users' preference, manual or automatic updating functionality enables, within minutes, the update to the latest FDA amendments.

Version 4.2 continues to support Human Prescription Drug Labels (HPDL), Human Prescription Drug Labels with Highlights (HPDLH), Veterinary Drug Product Labels, OTC, and Medical Devices along with NDC Labeler Code Requests, Establishment Registration and Listing SPLs as defined in the SPL Guidance Documents.

New features included in this release include:

  •     A4L's new SPL Updater functionality, which enables validation changes, FDA controlled terminology and UNII Code updates (based on the FDA resource files) automatically, eliminating the need for users to access the FDA web site separately.
  •     A searchable display of synonyms for UNII Codes is now supported to maximize confirmation and validation of all UNII codes
  •     A continually updated validation engine to assist in guiding the SPL authoring process.
  •     Validation process checks for postal codes and all non-US countries.

New templates and functionality to support new regulatory requirements in the following products:

  •     Bulk Ingredients
  •     Kit with Medical Devices with Highlights and Kit with Medical Devices without highlights as added by the FDA on May 4, 2009.

This latest release, A4L 4.2, incorporates automatic updates from the FDA when pertinent changes are made. A4L continues to support R3 with the ability to migrate legacy SPLs to the new R4 requirement, and includes an updated validation component that confirms that documents are compliant and valid, meeting both the XML validation requirement as well as the Implementation Guide requirements for content.

About i4i
Based in Toronto, Canada, i4i (http://www.i4i.com) is a world leader in the design and development of XML-based collaborative content solutions and technologies. The Company has a proven record of accomplishment and innovation having authored international standards and patented its technology. Through the use of i4i's comprehensive suite of products life science companies can author, verify, submit and manage product labeling requirements across the globe. i4i has successfully developed and deployed collaborative content solutions to customers in life sciences as well as other industry and governments around the world.

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Karen Heater
i4i Inc.
416-504-0141
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