Glemser Announces New Labeling Solution
Glemser Technologies, a Bethlehem, PA based pharmaceutical software and services company, recently announced SPL for DCM, a new out-of-the-box labeling solution based on Documentum's Documentum Compliance Manager (DCM) application. SPL for DCM provides a complete labeling content management solution and addresses the SPL Release 4 submission standard mandated by the FDA, and represents the latest addition to Glemser's family of pharmaceutical labeling solutions.
Glemser's SPL for DCM solution is built on the Documentum 6.5 platform, and is implemented as a set of feature extensions and configurations of Documentum's DCM application. This architecture provides the benefit of DCM's proven, user-friendly application environment while delivering a complete set of features focused on managing package inserts and related labeling documentation. SPL for DCM also includes the ability to generate a complete SPL Release 4 submission file from content managed in the DCM environment. Like Glemser's other labeling solutions such as xmLabeling, the system also seamlessly integrates with either the PTC/Arbortext Epic or In.vision XML editors for creation and editing of content, and includes is pre-configured with the required document types and workflows to address labeling content processes.
According to Andrew Glemser, Chief Technology Officer of Glemser Technologies, "The exciting thing about SPL® for DCM is that it provides our clients the opportunity to implement a complete labeling and SPL Release 4 solution within the DCM application environment. DCM already provides a set of capabilities to address FDA regulatory requirements for controlled content, and SPL for DCM adds additional functionality directly targeted at the management of labeling content. The result is a seamless application environment that extends the range of the DCM platform."
SPL for DCM is scheduled for general release in December of this year.
About Glemser Technologies
Founded in 1987, Glemser designs and implements XML and content management solutions for life sciences companies. Glemser's solutions include xmLabeling, the leading content management solution for pharmaceutical labeling, which includes support for SPL and PIM. Glemser solutions allow pharmaceutical, consumer healthcare, medical device, and biotechnology companies to effectively address their research and development, regulatory affairs, manufacturing, quality assurance, and sales and marketing content management needs.
For more information about Glemser Technologies and our other XML-based and SharePoint life sciences solutions, please visit us at www.glemser.com or contact us directly at inquiry@glemser.com.
SOURCE: Glemser Technologies