ROSETTA Phoenix eCTD Viewer

"It’s hard for most people to grasp important eCTD concepts like lifecycle and granularity until they’ve seen them in action. The best way I’ve found to teach these concepts is by using an eCTD viewer... to educate authors, project teams, and Regulatory staff about granularity and document lifecycles. I’m not exaggerating when I say that getting a viewer in front of people is probably the best thing you can do to help your company successfully adopt the eCTD." - Monte Levinson (Source...)

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 enjoy 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 dynamically without having to rely on any pre-built proprietary formats that need to be “refreshed” every time 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 v3.2; DTD v3.0 and v3.2
Health Canada DTD v1.0
European/EMA Module 1 DTD v1.0, v1.1, v1.2.1, v1.3 and v1.4
Japanese NIHS v1.0
Switzerland/SwissMedic v1.0.1
Taiwanese ESBF v1.0
U.S./FDA eCTD DTD v1.1, v1.2 and v2.0.1
FDA Study Tagging File specifications DTD v1.0, v2.0 and v2.2.

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 on one click
My Briefcase: Downloads documents from server to your local hard drive for offline viewing

It’s Portable! (Desktop Edition)

Runs as a stand alone Desktop application.
Copy-and-Paste deployment. You can even run it off a CD without installation.
Ideal for (internal/partner) distribution with submission content
Free redistribution of software (subject to terms of license agreement)

From individual Regulatory Affairs professionals to large life science companies, there are ROSETTA Phoenix eCTD Viewer solutions that can meet your needs and budget. Learn more...


	Support E.U. Module 1 specification v1.4.
	Support Japanese NIHS eCTD specifications
	Support Switzerland/SwissMedic eCTD specifications
	Support Taiwanese DoH ESBF M1 eCTD specifications
	Support Non-eCTD Electronic Submissions (NeES) (Desktop Edition only)
	Multi-language (Unicode) User Interface Support: English language pack is now available. Language packs for Chinese, French, German, and Japanese will be available on March 1, 2010.
	Regulatory Activity View: Related sequences can be grouped together as a Regulatory Activity (unit of approval). Each Regulatory Activity has its own Current and Cumulative Views so you now have the option of focusing on an individual regulatory activity or the entire eCTD dossier.
	Study Category View: Group pre-clinical and clinical studies by different Study Tagging File categories (species, route of administration, duration, type of control …etc). You now have new ways to find and view specific studies.
	One-click acces to Application Forms and/or Cover Letters right at the Sequence folder level. No need to expand the CTD structure! This allow users to quickly probe a submission before wondering into the forest of eCTD's Table of Contents.
	Support Command Line Parameter (Desktop Edition only): When setup correctly, this allows for maintaining submission information in a spreadsheet and launching the eCTD Viewer loaded with an eCTD application or Sequence of your choice right from within spreadsheet (similar to how hyperlinks work). (For enterprise solution for submission tracking with integrated eCTD viewer, check out our ROSETTA Pyramid Regulatory Tracking system.)
	Navigate back and forth between linked documents, including linked PDF documents, regardless whether documents are displayed in a PDF reader or inside a web browser. In addition, ROSETTA Phoenix Server and Enterprise Editions support navigation between linked documents stored in Documentum docbases.
	Integration with ROSETTA Annotation and Collaboration Service (Sever and Enterprise Editions only, licensed separately): To assist in reviewing and QC process, you can add comments and review notes to submission documents at any levels in the eCTD structure without altering the origional documents.