A Scalable, Cost-Efficient Viewing Solution
eCTDViewer® Web Edition is simple, easy to use, scalable, and appropriate for companies of all sizes. This
cost effective solution uses industry standard web browser applications, such as Internet Explorer®, Firefox®,
Google Chrome™ or Safari®, and can significantly reduce the cost of deployment and on-going ownership.
End users can be assigned with permissions to review electronic Common Technical Document (eCTD) and
Non-eCTD electronic Submissions (NeES) applications and submissions from anywhere.
eCTDViewer Web Edition provides the following features and capabilities:
Performance & Scalability
- Intelligent cache mechanism, offering instant display of the table of contents from large applications with 100s of submission sequences
- Indexed content ensures fast effective searching for content across the collection of applications
- Scalable architecture, enterprise application that scales to a large user base, achieved through application server cluster
- Database replication achieves optimal performance for global operations with user base in several countries utilizing a single repository
Navigation and Views
- Table of Contents: Current, Cumulative and Sequence views
- Integrated Document display supports all types of documents*
- Document Lifecycle display
- Document Properties display
- Powerful and fast search for metadata and content
- Administrative Information display
Usability & Efficiency
- User friendly
- Integrated commenting (annotating) capability
- Multiple reports
- Easy to deploy
- Easy to maintain
- Multi-language support
Technical
- Zero footprint client
- Browser based/HTML/Adobe® Flex® BuilderTM
- Windows and Java
- Adobe® Acrobat® Reader® support
Compliance
- eCTD
- ICH, USA, European Union, Canada, Japan, and Taiwan
- Study Tagging Files support
- SPL and PIM support
- Node extension support
- Non eCTD (NeES)
- Any type of electronic submission
Security
- Application level security
- User groups – applications can now be restricted to individual users or groups of users
- Roles – reviewer/administrator
Application Management
- Flexible and easy to use application administration features
- Add/edit/delete applications
- Add/edit/delete submissions
- Enable/disable applications submissions
- Manage content indexing
- Manage auto update and auto load of new and updated submissions
- Manage notification associated with the Commenting features
WebLogic and Apache Tomcat. Using a standards-based approach, Datafarm makes it possible for any organization, regardless of size, to seamlessly incorporate this application into their existing environment.
