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Open Text Regulated Documents

Microsoft® Office SharePoint® Server Edition

Open Text Regulated Documents, SharePoint Edition (former product name: Livelink ECM – Regulated Documents, MOSS Edition) is a solution for life sciences companies. It manages regulated documents on proposed new drugs or medical devices in a controlled environment built on the 2007 Microsoft Office system. The solution lets users work in their familiar Microsoft Office environment, while delivering compliance with U.S. Food and Drug Administration (FDA) regulations.

First introduced to life sciences companies in 2002, the new solution builds on Open Text’s experience from its successful Livelink ECM – Regulated Documents solution, and extends Open Text’s extensive and well-proven life sciences domain knowledge to a new ECM platform.

Compared to traditional, standalone regulated document applications, the new Regulated Documents 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.

• Features

Click each of the following features to learn more about the key capabilities of Open Text Regulated Documents for Microsoft SharePoint:

• Author documents  
  Document authoring is performed entirely in the familiar Microsoft Word 2007 environment. Document templates and workflows guide users throughout the process; automatic document numbering ensures that documents are identified in accordance with regulatory requirements. Document authors can connect directly from Microsoft Word to the SharePoint repository, to save new documents or to check-out existing documents, each time a change request is issued.
• Review documents  
  Using workflows and tasks, Regulated Documents helps you effectively manage the review and modification of documents. The solution supports major and minor document versions—which means revisions can be assigned minor version numbers. And once a document is formally approved, a major version is created. Typically, the system is configured to automatically archive major versions and associated audit trails, ensuring retention of official content.
• Approve documents  
  Using workflows and electronic signatures, Regulated Documents ensures that only documents that meet organizational guidelines, policies and procedures are approved. Electronic signatures are added to a non-modifiable rendition of the document. Regulated Documents fully manages signing authority administration in compliance with 21 CFR 11. This ensures that users can sign only the appropriate documents and that only authorized users can assign and revoke the signing rights of other users.
• Archive documents  
  Integrated archiving capabilities enable companies to ensure that regulated documents are retained and stored in accordance with internal policy and regulatory requirements. Both active and archived documents are accessible from the SharePoint interface with a single click, and can be retrieved with a single search.
• Transparent metadata management  
  The Microsoft Office 2007 system enables metadata to be embedded directly into documents and surfaced through a document template, which means this information is accessible and usable within applications like Microsoft Word. An InfoPath form allows users to provide information about each regulated document as an integrated step of the document creation process.
• Shared infrastructure  
  A unified architecture provides a common set of services—such as unified administration, integrated search, integrated user management and user rights, workflow, a Web Part Framework and a common usage pattern for document access regardless of the underlying repository. This ensures integration and consistency across MOSS 2007 and other ECM components. Customers can reuse applications, code and site content, enabling a common development and deployment experience for developers and IT professionals respectively.

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