Supported Regions

Datafarm^® VUE is a self contained stand-alone Windows desktop application for viewing eCTD submissions. Users are able to view validated or in-progress eCTD submissions that are created for any region, as long as the associated XML backbone files are DTD compliant.

VUE supports eCTD submissions created using the following specifications:

ICH eCTD specifications v3.2
ICH Study Tagging File (STF) specification, v2.6 (v2.2 and v2.0 DTD) - FDA Implementation

Regional Specifications:

Canada (CA) - v0.9 and 1.0
Europe (EU) - v1.0, 1.1, 1.2.1, 1.3 and 1.4
Japan (JP) - v0.1 and 1.0
USA (US) - v2.01
Swiss (CH) - v1.0.1
Taiwan (TW) - v1.0
Australia (AU) - Draft v0.00.02 (available in v1.2 Alpha only)

Features

Easy to use User interface

Intuitive visual indicator in the Table of Contents for lifecycle operations and status
Easy access to lifecycle history and document properties
Simplified life cycle operation
Visual indicators for cross-referenced documents along with detailed report

Performance and Portability

Allows users to open eCTD application with 100s of sequences instantly
Builds the Table of Contents on-the-fly based on the sequences selected
Intelligent caching, filters and refreshing techniques reduce loading time dramatically
Runs as a stand-alone Desktop application as well as on Citrix or Terminal server environment

Table of Contents - Multi-tab design

Current View
Cumulative View
Sequence View
Folder View

Display Panels – users have the option to customize the display and layout.

Document Viewer with Multi-Documents Display option
Administrative/Envelope View
Cross Reference Details
Properties Panel (Leaf/Section/STF/Node Extension)
Life Cycle Details Panel
Offline Content Details Panel

Filters – options to subset the submission content

Country (EU only)
Discipline
Module
Submission Activity

Leaf metadata
Section metadata
Administrative Information
STF and Node Extension metadata

Offline Viewing

Downloads documents from the server to your local hard drive for offline viewing
Built-in offline document management capability

Other unique features

Create a new submission sequence from the current view.
pTOC - Create a Word and PDF version of the TOC with links and bookmarks from any view.

Datafarm also offers enterprise-level solutions that are suitable for company-wide or global deployment. Datafarm’s eCTDViewer^® Web Edition provides role-based security as part of its enterprise-level capabilities for viewing submissions. This Web-based application supports both eCTD and Non-eCTD submissions (NeES).

Production Release

Sneak Peek...
Select and download an upcoming version of our software to see upcoming features.