Bethlehem, PA (PRWEB) February 19, 2008
Glemser Technologies Corporation (http://www.glemser.com) today announced that it will demonstrate the latest version of its xmLabeling® solution at the upcoming DIA 20th Annual EuroMeeting in Barcelona, 3-5 March 2008. Glemser's exhibit in booth # 55 will provide attendees with an opportunity to see a live demonstration of xmLabeling, Glemser's comprehensive solution for the management of global pharmaceutical labeling content. xmLabeling was recently used by a global pharmaceutical company to create and submit the first centralised registration procedure in Product Information Management (PIM) format to the European Medicines Agency (EMEA) using a commercial software product.
xmLabeling provides an expanded set of features and functions that directly support the management of global labeling content in all European Union (EU) languages and the generation of submittable, agency-specific, XML output. Specific PIM capabilities include:
- Support for the latest Data Exchange Standard (DES) version
- Ability to generate a multi-lingual PIM submission in any or all EU languages
- Full support for 2-way collaboration (i.e., commenting) between the Applicant and the regulator, including the ability to automatically load and manage comments received from the EMEA
- Ability to generate full or delta PIM submissions
- A new "dashboard" interface that allows users to easily manage and monitor complex PIM submissions
These capabilities extend the existing architecture of xmLabeling, which is built on Documentum's WebTop platform. xmLabeling is an accredited "Designed for Documentum" application and provides the next generation framework for XML-based structured content management. xmLabeling includes pre-configurations to address regulatory requirements for labeling submissions in the Structured Product Labeling (SPL) format for the Food and Drug Association (FDA) in the United States and in PIM format for centralised submissions to the EMEA in Europe.
About Glemser Technologies
Founded in 1987, Glemser designs and implements XML and content management solutions for life sciences companies. Glemser's solutions help our pharmaceutical, consumer healthcare, medical device, and biotechnology clients effectively address the information management needs of their research and development, regulatory affairs, manufacturing, quality assurance, and sales and marketing organizations. For more information about Glemser Technologies and xmLabeling, please visit our Web site at http://www.glemser.com or contact us directly at firstname.lastname@example.org
Public Relations Contact:
Manager, Corporate Marketing
Nancy.hamblet @ glemser.com
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