Glemser Technologies Ships xmLabeling® 4.1 for PIM
Glemser Technologies, a Bethlehem, PA based pharmaceutical software and services company, today announced that they have released the next version of xmLabeling, their comprehensive solution for the management of global pharmaceutical labeling content. xmLabeling 4.1 provides an expanded set of features and functions that directly support the management of European labeling content and the submission of labeling documents to EMEA, the European Union health authority, in the Product Information Management (PIM) format.
Bethlehem, PA (PRWEB) February 9, 2007 -- Glemser Technologies, a Bethlehem, PA based pharmaceutical software and services company, today announced that they have released the next version of xmLabeling, their comprehensive solution for the management of global pharmaceutical labeling content. xmLabeling 4.1 provides an expanded set of features and functions that directly support the management of European labeling content and the submission of labeling documents to EMEA, the European Union health authority, in the Product Information Management (PIM) format.
According to Andrew Glemser, CTO of Glemser Technologies, "This set of enhancements is designed to enable our clients to fully meet the integrated labeling needs of global pharmaceutical companies. With xmLabeling 4.1, our clients can optimize their global labeling business processes and share, re-use, and re-purpose labeling content intended for submission to various health authorities around the world."
Key aspects of xmLabeling 4.1 include:
| | - Ability to generate complete PIM submissions from the "Health Authority Neutral" content model supported by xmLabeling
- Support for the interactive exchange of comments and revisions between applicants and regulators
- Pre-configurations for European labeling document types, such as Summary of Product Characteristics, Package Leaflet, Labeling Text (Outer, Immediate, and Blister), and Annex II
- Advanced compliance tracking functionality to ensure that changes made to master documents, such as Core Data Sheets, are implemented in all applicable national labeling documents
- Content profiling capabilities enabling authors to manage content for various product formulations, strengths, and presentations from within a single content file
- Enhanced security functionality providing additional control of country-specific confidential labeling content
- Document comparison functionality to automatically generate and display the differences between disparate XML-based documents or multiple versions of the same document
- User interface enhancements to facilitate the re-use and re-purposing of existing labeling content fragments
- Qualification and support of additional platforms, including content server and BEA Weblogic application servers running on Solaris 9.
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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 4.1 includes pre-configurations to address regulatory requirements for labeling submissions in Structured Product Labeling (SPL) format to the FDA and in Product Information Management (PIM) format to EMEA.
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 www.glemser.com.
Public Relations Contact:
Ken Lownie
Vice President and Chief Operating Officer
610-317-9400 ext. 4705
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