Bridgewater, NJ (PRWEB) May 1, 2007
ThinSpring, a leading provider of XML-based solutions such as SPL Server and the FDA’s Electronic Labeling Information Processing System (ELIPS), announces the release of XML Sage 3.1 with automatic conversion to the Physician Labeling Rule (PLR) for Structured Product Labeling (SPL) using SPL Server. This upgrade represents the ongoing commitment that ThinSpring has to giving its customers a software product that guarantees seamless and effortless compliance with emerging regulatory requirements.
“This upgrade allowing built-in conversion from existing SPL to PLR is a major stride forward in SPL software for the entire pharmaceutical industry.” said Ron Celeste, President and CEO of ThinSpring. “Nobody else in the industry is prepared to offer such a comprehensive SPL-PLR solution, and offer it today in their current product. When you get SPL Server, you get the ability to convert SPL to PLR at will.”
Federally Mandated PLR Requirements
Bound by federal mandate, the United States Food and Drug Administration (FDA) has required that all NDAs, BLAs, and Efficacy Supplements submitted after June 30, 2006 conform to the SPL-PLR rule. In addition, all NDAs, BLAs, and Efficacy Supplements approved since June 30, 2001 must be converted to the SPL-PLR format in the course of a 7-year implementation window.
What’s New With PLR?
Some new elements have been added as a result of the PLR mandate including the Highlight Text section, table of contents, expanded codes, more medical terms, more reference tables, appended patient labeling, and Full Prescribing Information (FPI). ThinSpring software is designed for complete compliance with the new SPL-PLR requirements including push-button conversion from the original SPL format to the new SPL-PLR format.
The ThinSpring Solution
The FDA currently uses ELIPS as a part of the process to receive, internally validate, store, approve and transmit SPL submissions from pharmaceutical manufacturers. From the experience of developing ELIPS, ThinSpring is able to provide effective and reliable XML submission and structured data management solutions. The ThinSpring solution is world-class architecture supported by the best and most experienced subject matter experts in the industry.
For more information, go to the ThinSpring website or contact Earl Pendleton at (919) 654-4535.
About ThinSpring:
ThinSpring, founded by former pharmaceutical and medical device professionals, specializes in XML-based Web service solutions, integration and data conversion. ThinSpring has used its industry expertise to develop a dynamic XML engine, MatriXML. This patented XML technology is the basis for SPL Server. ThinSpring’s solutions have gained acceptance as an essential, collaborative application-development platform for FDA regulated companies. ThinSpring’s core team manages technology and regulatory consulting divisions that support its clients’ operations throughout the United States, Europe, Asia and South America. ThinSpring headquarters is in Bridgewater, New Jersey, with offices in California and North Carolina. More information about ThinSpring and ThinSpring SPL Server can be found on their website at: http://www.ThinSpring.com.
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