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• Open Text Case Management Framework SharePoint Edition
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Regulated Documents

Edition for Microsoft® Office SharePoint® Server

Based on Microsoft Office SharePoint Server technology, Livelink ECM - Regulated Documents, Edition for Microsoft Office SharePoint Server is designed to meet the stringent requirements of the pharmaceutical industry, adding key capabilities to address 21 CFR Part 11 compliance using SharePoint. Livelink ECM – Regulated Documents for Microsoft SharePoint securely manages documents through a controlled lifecycle, in compliance with regulatory requirements.

Combined Microsoft and Open Text deliver core document management and retention capabilities, workflow with extended auditing and reporting capabilities, and electronic signature support, helping companies manage the SOPs that describe 21 CFR 11 compliance procedures and best practices.

• Features

Click each of the following features to learn more about the key capabilities of Livelink ECM - Regulated Documents for Microsoft SharePoint:

• Supports all document lifecycle phases  
  Livelink ECM - Regulated Documents supports all document lifecycle phases, including Authoring, Review, Approval, Release, Change, Retirement and Archiving.
• Complies with all applicable good practice regulations  
  Livelink ECM - Regulated Documents complies with all of the applicable good practice regulations for laboratories, clinics and manufacturing, with the U.S. Food and Drug Administration's (FDA's) 21 CFR Part 11 regulation regarding electronic records and signatures, as well as with other related regulations.
• Approve documents with electronic signatures  
  Livelink ECM - Regulated Documents enables signatures to be added to non-modifiable renditions of documents. Signing authority administration is facilitated in full compliance with FDA 21 CFR 11 requirements.
• Stores content in a powerful, highly scalable repository  
  The Livelink ECM - Regulated Documents repository is capable of managing many millions of documents. The repository can handle numerous types of documents, including text documents, spreadsheets and drawings. A unified architecture provides a common set of services such as unified administration, integrated search, integrated user and rights management, a web part framework, and more. This ensures integration and consistency across Microsoft SharePoint and other ECM components.
• Automates document numbering  
  Enable automated document numbering based on document type.
• Controls document versions  
  Regulated Documents integrated version control features include document reservation, change history and audit trails. Users can check in and check out files (directly from Microsoft Word), to ensure that other users do not interfere with their work. Change histories provide quick access to previous versions of documents. Audit trails contain a detailed record of when, what and why changes were made to documents.
• Supports content categorization via rich metadata features and taxonomic classifications  
  Regulated Documents provides rich metadata features, including customizable categories and attributes, with examples provided. Categories enable you to add custom metadata to repository objects, enabling you to effectively organize your knowledge assets. Users can easily apply attribute metadata to documents directly from the Microsoft Word interface. Regulated Documents includes support for applying taxonomic classifications to documents, with examples provided.
• Integrates with desktop productivity tools  
  Using Regulated Documents' desktop integration features, document authors and reviewers can connect directly from Microsoft Word to the Regulated Documents repository to save new documents or to check out existing documents for which there has been a change request. Document reviews by multiple reviewers are performed collaboratively with SharePoint.
• Controls archival and disposition of content changes  
  The document lifecycle ends with the withdrawal and eventual purge of documents from the Regulated Documents repository. Regulated Documents' records management capabilities help you control the archive and final disposition of documents. Records managers issue a query to locate all inactive controlled documents in the Regulated Documents repository and set the status to "archive."
• Transparent metadata management  
  Microsoft Office 2007 enables metadata to be embedded directly into documents and surfaced through a document template, making this information 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 or modification process.

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