ROSETTA pyramid: eCTD archive for paper and electronic submissions

ROSETTA pyramid: eCTD archive

ROSETTA pyramid is the retrieval solution based on EMC Documentum.

It is an “active” archive of a submission – paper or electronic – for immediate retrieval and it’s 21 CFR Part 11 compliant. It provides powerful search tools and immediate access to submission documents offering the best defense in the event of auditing, litigation and legal discovery. With the advent of eCTD, the lifecycle of a document isn’t final after submission. Reference to a document and lifecycle operations may occur anytime. This changes the notion of an “archived” document as something simply filed away “in case” it’s needed; archived documents must be available for immediate retrieval. ROSETTA pyramid provides automatic indexing for eCTD submissions and includes an embedded version of ROSETTA phoenix to facilitate the navigation of those submissions and the immediate retrieval of their content. Combined with our migration service, ROSETTA pyramid can be your single system for all your company’s submission records and documents.

Key Benefits:

Helps Regulatory Affairs to extract the maximum value from its information - efficiently and at the lowest cost.
Expedites the drug approval process.
Helps you to quickly respond to health authorities or government agencies, in case of an audit or litigation, with minimum resources.
Enables you to comply with regulatory requirements.

Product Features:

Support paper and electronic submissions
Include an embedded version of ROSETTA phoenix - an eCTD viewer
Submission Logging and Indexing
Searching and Reporting
Content Retrieval and Navigation
Content Management
Workflow Integration
Maintain inter-document PDF links

Functionality Overview

Track and archive submissions to health authorities, as well as communications from them.
Out-of-the-box support for U.S. and E.U. application types (such as IND, NDA, MAA, CTA, etc), and submission types (Initial IND, Original NDA, Supplement, Amendment, Protocols, Adverse Event, etc).
Centrally assign IND serial numbers.
Powerful search tools (one-click search, full-text search, etc).
Create chronology reports and export to Microsoft Excel.
Content importer and exporter, that each handles both small and large submissions.
eCTD Viewer and PDF hyperlink navigation - right inside the system.
Notification of key events.
Out-of-the-box support for the QC process.
Configurable and customizable Documentum WDK-based solutions.
Compliance - ROSETTA pyramid is a validated and 21 CFR Part 11 compliant system.

ROSETTA eCTD phoenix: eCTD View sceptre: eCTD Validate scribe: eCTD Publish pyramid: eCTD Archive