i4i's New Release of A4L Professional Version 4 Delivers New Functionality and Meets Latest FDA SPL 4.0 Requirements for Life Science Enterprises
i4i Inc., a world leader in the design and development of collaborative content solutions and technologies for life sciences announced today that they have released the latest version of A4L Professional, Version 4.
Toronto, ON (PRWEB) November 25, 2008 -- i4i Inc., a world leader in the design and development of collaborative content solutions and technologies for life sciences announced today that they have released the latest version of A4L Professional, Version 4.
This release of A4L Version 4, continues to deliver a superior platform that supports a complete SPL R4 solution for all Life Science enterprises. The latest version supports the full authoring, submission, validation and label management process including support for Human Prescription Drug Labels (HPDL), Human Prescription Drug Labels with Highlights (HPDLH), NDC Labeler Code Requests, Establishment Registration and Listing SPLs as defined in the SPL Guidance Documents.
A4L Version 4, based on i4i's patented technology, continues to lead the market in user acceptance through the use of the familiar MS Word based interface. This intuitive A4L interface incorporates updated drop down menus that use FDA controlled vocabularies, and dialog boxes that allow the user to create and manage product information required in the labeling and submission process.
The SPL 4.0 standard is designed to support the following required regulatory submissions in an electronic format:
| | - Labeler Code Requests,
- Drug Establishment Registration
- Drug Listing / Content of Labeling
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i4i has included templates and functionality to support new regulatory requirements surrounding the following products:
| | - all human prescription drugs (HPD), proprietary & generic, with or without highlights, under CDER;
- all human over the counter drugs (OTC), under CDER;
- all biological products, such as blood products, vaccines, human tissue, under CBER and CDER;
- all veterinary medicines and medicated feeds, prescription or over the counter, under CVM.
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i4i's A4L Version 4, continues to support R3 with automatic migration of legacy SPLs to the new R4 requirement and, includes a 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.
"We are pleased to continue supporting the life science industry's need for state of the art XML technology that supports the FDA's SPL submission requirements," commented Michel Vulpe, CTO i4i Inc. "Utilizing our knowledge of XML authoring and document management solutions i4i's latest version of A4L pushes the envelope to surpass regulatory standards, facilitate risk reduction, and increase document production efficiencies for our customers."
i4i continues to play a leadership role in the development of the SPL standard, working closely with the FDA and industry. Information on the new SPL R4 requirements and i4i's release of products and services to ensure compliance is available at www.i4i.com.
About i4i
Based in Toronto, Canada, i4i (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 labelling 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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