Records Management

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Regulated Documents

End-to-end document lifecycle management, in compliance with regulations

Pharmaceutical and life sciences, financial services, energy & utility, and government organizations are subject to strict regulations that dictate how, when and under what circumstances electronic documents can be authored, updated, approved, published and archived. Regulated industries need to make compliance with regulations an integral part of their document management and control processes to reduce risk and gain competitive advantage by bringing new products to market faster.

Originally designed to meet the stringent requirements of the pharmaceutical industry, Livelink ECM - Regulated Documents is a complete application to securely manage key documents throughout a controlled lifecycle in compliance with relevant regulatory requirements.

• Features

Click each of the following features to learn more about the key capabilities of Regulated Documents:

• Supports all document lifecycle phases  
  Regulated Documents supports all document lifecycle phases, including Authoring, Review, Approval, Release, Change, Retirement and Archiving.
• Complies with all applicable good practice regulations  
  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.
• Adds electronic signature capabilities to forms and workflows  
  Add signing events to workflows, and signature pages to electronic forms, providing the authentication characteristics of paper-based processes to electronic processes.
• Stores content in a powerful, highly scalable repository  
  The 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.
• Ensures access control with nine-level permission model  
  Provides nine levels of objects permissions linked to document status, with role-based, controlled access. Access controls include See, See Contents, Modify, Edit Attributes, Reserve, Delete and more, providing powerful, scalable control over which users can perform which actions.
• 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, 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, to categorize and browse information according to alternative conceptual themes rather than according to the folder hierarchy. Regulated Documents includes support for applying taxonomic classifications to documents, with examples provided.
• Provides extensive collaboration features  
  Extensive synchronous and asynchronous collaboration features to support collaborative authoring and review processes.
• Integrates with desktop productivity tools  
  Using Regulated Documents' desktop integration features, document authors and reviewers can connect directly from Microsoft Word or Adobe Acrobat 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 Regulated Documents. Multiple reviewers can easily add their own comments concurrently as layers.
• Includes sample database and standard operating procedures  
  Includes sample business content to provide a framework for managing regulated documents, including an information architecture, document templates, workflows for each lifecycle phase, records management plans and reporting tools.
• 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."
• Supports multiple, parallel review  
  Many people can participate in a concurrent review of a document without overwriting the comments of others or changing the original document. Each reviewer's comments are saved independently, and can subsequently be accepted or rejected by the author or editor of the original document.

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