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Liquent Regulatory Solutions for Life Sciences

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Liquent InSight Foundation®: Features & Benefits

Features

InSight Foundation is a full-featured browser based solution that leverages leading DMS technology from Documentum®, helping to form the basis of your entire document management strategy.

Features include:

> Best Practices Repository Model to reduce manual effort and eliminate inconsistencies

  • Pre-configured best practice repository model built on CTD/eCTD
  • Automatically creates document storage locations
  • Supports legacy documents (documents not designed for CTD/eCTD submissions)
  • Provides cabinet/folder configuration and properties for CTD/eCTD publishing

> Best Practice Document Security and Lifecycle Models

  • Provides document lifecycle state designations and the ability to create event-based workflows
  • Automatically changes security when document changes to a different state
  • Integrates with Documentum workflows

> Document Types and Template Management

  • Delivered with complete set of pre-defined document types
  • Provides full lifecycle support for template management
  • Accomodates import of your existing document templates
  • Available best practices authoring templates

> Compliance Features

  • Provides electronic signature capture and manifestation capabilities
  • Includes robust audit trails on all document activities
  • Supports 21 CFR part 11 compliance requirements
  • Built upon Liquent’s Software Development Lifecycle methodology which is readily auditable at Liquent.
  • Validation-ready with IQ and OQ scripts provided (PQ options also available)

> Dictionary Maintenance and Document Relationships

  • Provides drop down list of specific document properties (e.g, drug name, status etc) that ensure consistent use for document properties
  • Allows administrators to easily define and modify property dictionaries as required helping to enforce standardization.
  • Enables you to create and view labeled relationships between documents that include translations, correspondence and amendments.

> Collaborative Authoring and Review

  • Includes RenderPerfect for automatic PDF renditions used for review and approval processes.
  • Leverages standard Microsoft® Word reviewing functionality
  • Optionally provides advanced parallel review capabilities using InfoData’s AnnoDoc

> Integration

  • Full integration with CoreDossier, CoreReports and EZsubs publishing systems

Benefits

  • Consistency: Establish and maintain a common content repository which will reduce paper document handling, streamline document retrieval, eliminate file duplication and provide a single source from which to assemble and track regulatory reports and submissions.
  • Content-Readiness: Implement a system that comes standard with pre-designed document types and can accommodate multiple content types
  • Compliance: Confidently deploy a solution that conforms to compliance guidelines
  • Collaboration: Break down the barriers between your knowledge capital with true global authoring and review teams
  • Configurable: Configure (not customize) the system wherever the pre-loaded best practices don’t address a particular business requirement
  • Cost-Effective: Single, highly configurable, Web-based solution that has been built on best practices as opposed to multiple tools or a highly customized DMS system that is nearly impossible to maintain.