Boston, MA (PRWEB) September 14, 2008
i4i Inc., a world leader in the design and development of collaborative content solutions and technologies today announced the integration of AliCE 4 Labeling (A4L) from i4i and Register™.
A4L is a market-leading XML-based product label and authoring application, while Register™ is the market-leading solution that offers a central repository for managing the end-to-end tracking of global product registration details and submissions. The integrated applications will provide a comprehensive solution for centrally managing products, tracking and planning global registrations, and addressing all authoring and lifecycle management aspects of e-label production.
During the RAPS Conference, i4i will be presenting the integrated solution in booth #526 at the Hynes Convention Center while Aris Global will be presenting Register and A4L in booth #414.
"Complying with the Structured Product Labeling (SPL) and Product Information Management (PIM) standards represent a huge challenge for life science organizations that have disparate systems worldwide for managing product information," said Wim Cypers, vice president, product management, Aris Global. "With the integration of Register and A4L, authors now simply use drop-down menus from the A4L environment to retrieve the full range of validated, approved and authoritative detailed product information that resides in Register's central repository to create a SPL/PIM e-label. Because Register is designed to collect, store and manage detailed product information from multiple sources, companies can rest assured that what is said about a drug product in one document is materially consistent with what is being said in another document and across the global, complex organization."
In addition to avoiding out-of-compliance situations, the joint solution enables organizations to easily manage and track updates and variations and determine the regulatory impact of any proposed changes. For example, when a formulation is updated, users can distinguish which products, registrations, labels and documents are impacted and also automatically notify the stakeholders of the change. In another example, when there is a production variation, the integrated solution automatically determines which SPL/PIM files in the A4L environment is impacted by the proposed change.
"At the end of the day, this is all about giving healthcare providers and patients access to accurate and consistent healthcare information in a timely manner," said Michel Vulpe, CTO and Founder, i4i. "The integration of A4L and Register delivers on that objective, by giving life science organizations a unified solution for regulatory submission tracking and product label authoring and lifecycle management that ultimately ensures materially consistent and therefore better quality compliant labels for the global market."
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, governments and other industries around the world.
About Aris Global
Based in Stamford, CT, Aris Global (http://www.arisglobal.com) is a leading provider of integrated software solutions for pharmacovigilance and safety, regulatory affairs, clinical research and medical information. More than 300 direct and indirect life science customers rely on the company's advanced solutions for maintaining regulatory compliance, managing and mitigating risk, improving operational efficiency and easily sharing information on a global basis.
Aris Global is a registered trademark and Register is a trademark of Aris Global. Other product or company names mentioned herein are the trademarks of their respective owners.
Tel: (416) 504-0141
kheater @ i4i.com
pstites @ arisglobal.com
Tel: (203) 588-3045
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