CIMdata PLM Industry Summary Online Archive
13 February 2007
Product News
Open Text to Deliver Regulated Documents Solution on the Microsoft Office SharePoint Server 2007 Platform
Open TextT Corporation said it will introduce a new solution for life sciences companies that manages regulated documents on proposed new drugs or medical devices in a controlled environment built on the 2007 Microsoft Office system. The solution, which will be available in March, lets users work in their familiar Microsoft Office environment, while delivering compliance with U.S. Food and Drug Administration (FDA) regulations.
Open Text announced the news today in conjunction with its Summit 2007 user conference underway this week in Huntington Beach, California.
With Open Text Regulated Documents for Microsoft Office SharePoint Server 2007, companies will be able to use 2007 Microsoft Office applications to manage, author, review and approve content in a controlled environment that is compliant with specific FDA guidelines, such as its 21 CFR Part 11 regulations. The new solution builds on Open Text's experience from its successful Livelink ECM - Regulated Documents solution, first introduced to life sciences companies in 2002, and extends Open Text's extensive and well-proven life sciences domain knowledge to a new ECM platform.
"Open Text's new solution takes full advantage of the new features in the 2007 Office system, including Microsoft Office SharePoint Server 2007, to increase the effectiveness of users in highly regulated environments," said Steve Shihadeh, General Manager of Healthcare and Life Sciences at Microsoft Corp. "Because this solution taps Open Text's extensive pharmaceutical and life sciences expertise, it will offer companies using SharePoint Server 2007 immediate productivity benefits by working in a system that is already FDA-compliant, while also stepping up to meet enterprise-wide scalability."
Compared to traditional, standalone regulated document applications, the new solution takes advantage of the collaboration features in Microsoft Office SharePoint Server 2007, such as the document information panel, Windows Workflow Foundation, InfoPath Forms and content management capabilities, to significantly improve the end-user experience and enhance productivity.
For example, the solution uses metadata information supplied by the user (such as document owner or date created) to automatically update appropriate content inside a document, and then uses that metadata for ongoing records management and archiving. Microsoft content types are used to classify documents and related workflows so that the processes most appropriate for each type of document can be easily and consistently followed. All user activities take place in the well-known Microsoft Office environment, making it easy for users to adopt this new solution as part of their daily work.
"By building this solution on the 2007 Microsoft Office system, we were able to hide the heavy lifting in managing the complicated workflows and review processes for regulated documents, resulting in a superior user experience," said Brett Shellhammer, Senior Vice President of Business Solutions for Open Text.
"We see our Regulated Documents for Microsoft Office SharePoint Server 2007 not as a standalone solution, but as offering an approach suitable for many companies and organizations within and outside of the FDA's sphere of influence," Shellhammer added. "As Microsoft points out in its white paper 'Enterprise Content Management in Regulated Industries,' ( http://www.microsoft.com/industry/healthcare/lifesciences/businessvalue/whit epaperecm.mspx ) the challenge of working with Regulated Documents goes beyond the life sciences industry. Our new Regulated Documents solution provides a platform for creating compliant applications."
The introduction of Open Text Regulated Documents for Microsoft Office SharePoint Server 2007 is a continuation of Open Text's strategic direction to build solutions based on ECM infrastructure technology provided by major platform providers, such as Microsoft. Over the coming year, Open Text will deliver additional solutions based on Microsoft Office SharePoint Server 2007 for the pharmaceutical and life sciences industry, while also building solutions for other industries, such as energy that are also required to manage the document lifecycle process.
Open Text Regulated Documents for Microsoft Office SharePoint Server 2007 will be available in March of 2007. 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 on the Summit 2007 Conference, go to http://events.hummingbird.com/summit/2007/index.html .
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