CIMdata PLM Industry Summary Online Archive
11 June 2007
Events News
Open Text to Showcase Leading Life Sciences Solutions at the Drug Information Association (DIA) Meeting in Atlanta
Open TextT Corporation announced that it will showcase its solutions for pharmaceutical and life sciences companies at the 2007 Drug Information Association (DIA) Meeting to be held in Atlanta, Georgia, June 17 - 21 at the Georgia World Congress Center. Open Text will demonstrate its industry specific applications at booth # 115.
Open Text's industry specific applications for life sciences include solutions for regulatory content and submissions management, quality management, and clinical trials. Other business related applications Open Text is helping pharmaceutical and biotechnology organizations with include: internal controls, contract management and litigation support, email management, records management, Web content management, and ERP/CRM archiving.
At booth # 115, Open Text will showcase the following solutions:
Regulated Documents for Microsoft Office SharePoint Server 2007 , which builds on Open Text's experience from its successful Livelink ECM - Regulated Documents solution, first introduced to life sciences companies in 2002. The solution extends Open Text's extensive and well-proven life sciences domain knowledge to a new ECM platform. The solution will allow companies to use 2007 Microsoft Office applications to manage, author, review and approve content in a controlled environment that is compliant with specific U.S. Food and Drug Administration (FDA) guidelines, such as the 21 CFR Part 11 regulations.
Livelink ECM - Quality Management System , which provides a fully integrated solution that complies with the electronic records provisions of the FDA's 21 CFR Part 11, while addressing the needs for Pharmaceutical Best Practice (21 CFR 210 and 211), Biological Best Practice (21 CFR 600-680) and Medical Device Best Practice (21 CFR 820). The system is a flexible and expandable solution that integrates the key processes required for life sciences organizations, including Audit, Training, and Regulated Document Management into an enterprise-level solution.
Livelink ECM - Collaborative Submissions , which is designed to help companies manage the assembly, review, approval and release of large document submissions that are made to government regulatory bodies responsible for drugs, biologics and related products. The comprehensive solution drastically reduces time to market by enabling companies to prepare and make submissions in the industry's eCTD (Electronic Common Technical Document) format. eCTD submissions can contain thousands of documents which have to be carefully managed through their respective lifecycles. Each submission in turn is part of an overall product application that requires updates, amendments and follow-on submissions.
"Life sciences companies have some of the most complex and highly regulated document processes in use today, so they need sophisticated ECM solutions," said Brett Shellhammer, Vice President of Business Solutions for Open Text. "Our industry specific solutions, best practices, and strong network of partners who develop, validate and deliver Open Text based solutions, sets us apart from other software providers. We look forward to showcasing our extensive portfolio at the DIA Meeting in Atlanta."
For more information on the full range of Open Text pharmaceutical and life sciences solutions go to: http://www.opentext.com/2/sol-industry/sol-ind-pharma.htm .
For more information about the DIA's 43rd Annual Meeting, go to: http://www.diahome.org/DIAHome/FlagshipMeetings/home.aspx?meetingid=11362
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