ROSETTA Phoenix™ eCTD Viewer is a feature-rich yet easy-to-use eCTD viewer for viewing regulated submissions prepared in Electronic Common Technical Document (eCTD) format.
It’s easy! You don’t need to learn a new language to use ROSETTA Phoenix.
Designed for the sole purpose of viewing eCTD submissions, ROSETTA Phoenix is specifically for users who do not need to
know the technical aspects of eCTD. ROSETTA Phoenix does not use any jargon or functionality restricted only to those who assemble,
compile or publish eCTD submissions. Most users can start using and enjoying ROSETTA Phoenix eCTD viewer without any training.
There is no doubt that eCTD publishing software is cumbersome for general users. This is why our customers choose ROSETTA Phoenix for viewing eCTD submissions, even though they may use another vendors’ eCTD publishing software.
It’s fast! It’s easy on the outside but fast on the inside!
ROSETTA Phoenix’s smart eCTD loading and processing engine is among the fastest in the industry.
Many companies select ROSETTA Phoenix eCTD viewer over other viewers because it outperforms other eCTD viewing/reviewing software
in terms of the loading speed and the time it takes to construct the full lifecycle current and cumulative views.
Furthermore, it does so without having to rely on any pre-built proprietary formats that need to be “refreshed”
which is subject to human or process errors when there is a new eCTD submission.
Four of the world’s largest pharmaceutical companies and other mid-size companies have chosen ROSETTA Phoenix Enterprise Edition as their global standard of viewing eCTD submissions primarily because of its fast loading capability.
It’s compliant! ROSETTA Phoenix is compliant with the latest eCTD specifications and is backwards-compatible with previous specifications from ICH and Canadian, E.U., Japanese, Swiss, Taiwanese, and U.S. regions. Any eCTD submissions, even those produced by other software vendor’s publishing tools, can be viewed through ROSETTA Phoenix, as long as they conform to ICH and regional eCTD specifications.
Compliance
Supports the latest international and regional eCTD specifications and is backwards-compatible with earlier specifications.
- ICH eCTD specifications
- Regional specifications: Health Canada, European Union/EMA, Japan/NIHS, Switzerland/SwissMedic, Taiwan/FDA and U.S./FDA, Saudi Arabia/GCC and South Africa/MCC
- U.S. FDA Study Tagging File specifications
Easy Navigation and Viewing
- Table of Contents View: Compliant with electronic Common Technical Document (eCTD) and regional section headings
- Multi-tab design: Keeps multiple documents open and organized
- Exposes all metadata for repeating sections, e.g. section 5.3.P.4
- Filters for modules – see only the modules you want to see
- Powerful and fast search on submission metadata and document titles
Lifecycle Operations
- Intuitive visual indication for lifecycle operations and status
- Easy access to lifecycle history
- Open all "appended" documents in one click
- Supports both implicit and explicit lifecycle operation models
Smart Loading and Fast Performance
- Allows users to open a specific submission or the entire application
- Builds the Table of Contents and the Current View on-the-fly
- Smart caching, compression and refreshing techniques cut down loading time dramatically
Productivity Tools
- Batch printing: Prints multiple documents with one click
- My Briefcase: Downloads documents from server to your local hard drive for offline viewing
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