ROSETTA eCTD Viewer Desktop Edition Features
Quick Deployment and Access
- Lightweight, quick install Windows application.
- View submissions instantly without any preprocess, upload, or migration required.
- Easily access any eCTD storage location available through Windows. This includes Local drive, Network drive, Cloud share mounted drive e.g. Sharepoint through OneDrive, Box, Citrix, Egnyte.
- Discover all eCTD submissions in a repository for one-click access.
- eCTD submissions are optimized for faster subsequent viewing in particular for submissions stored in a cloud storage location.
- Pin favorite submissions for one-click quick access.
- View the lifecycle of a submission in Current or Cumulative View Modes.
- View the revisions and lifecycle status of any document.
- Utilize multiple View Modes (Table of Contents, Sequences, Regulatory Activity, Study, Folder) to fit any workflow.
- Embedded PDF Viewer displays contextual document information including Application Type, Application Number, Sequence Number, Document Title and Lifecycle Status.
- Open documents in tabs in ROSETTA eCTD Viewer, send them to a secondary display, or your choice of PDF tool (e.g. Adobe).
- Bookmark important documents for quick access.
- Display and Export Reports of Studies, Regulatory Activities, Sequence Chronology, Section Attributes, and Cross-referenced Files.
- Export the Table of Contents in HTML, spreadsheet (XLS), or text (TXT) format with the files (optional).
- Display all of the hyperlinks in a PDF. This report can verify hyperlink page locations, target destinations and validity.
- Verify and Display a report of file checksum integrity.
- View all sequences of an eCTD application or dossier.
- View submissions of any regional eCTD specification (US, EU, CA, JP, CH, AU, GCC, ZA, TW, TH, JO, KR, CN, and EAEU).
- View Non eCTD Electronic Submissions (NeeS).
- Add sequence to view an in-progress sequence with existing eCTD submissions.
- Use Filter options to customize the modules, sections, and sequences displayed.
- Append submission metadata (Sequence number, Submission Date, Submission Type) to the document title for further clarity.
- Merge repeating sections with different attribute values into single sections. For instances of a merger or acquisition, this option can display relevant sections as a single organized section.
- Display placeholder empty sections for sections that are defined without documents.
- Search the Table of Contents for specific strings that occur in modules, submission types, or sequences.
- Search the Study modules (M4 and M5) for specific strings that occur in study categories or study document file tags.
- Sort Table of Contents documents by the sponsor defined order, file name, or document title.
- Sort Study View studies by Study ID or Study Title.
- Batch documents for printing at once with the Print Job tool.
- User Interface available in multiple languages (English, Chinese Traditional, Chinese Simplified, Korean).
- Display specific eCTD regions section titles in alternate languages as defined by the specification (China, Taiwan, Korea).