The XML backbone containing the metadata of a submission requires a navigational aid such as a style sheet in order to view its contents meaningfully.
eCTDViewer® provides easily navigable features allowing the user to review the contents of a submission or a library of submissions. It allows the reviewers to comment on the contents of application(s) throughout its life cycle.
This application also includes an optional validation module (Gatekeeper) that verifies the validity and integrity of the submission and paper dossier (pCTD) publishing module.
Features: - Most Recent ICH and Regional DTD support
- STF 2.2 support
- Submission and Document Life Cycle view support
- Japanese language support
- Ability to review multiple applications at the same time
- Descriptive table of contents display
- Cumulative and Current view support
- Hierarchical/Tabular view for table of contents
- Summary at submission, section and leaf levels
- Direct access to PDF pages via bookmarks
- Simple and Advanced search capability
- Ability to create Favorites at section, document and PDF page level
- Visual indicators to represent leaf status and operational attributes
- Off-line
- Ability to selectively create workspace for off-line review
- Ability to review and comment
- Synchronize comments when online
- Printing
- Ability to print single and multiple documents/sections/modules
- Ability to print Table of Contents from XML with hypertext links
- Comments (Notes)
- Ability to add notes at document and page level
- Public/Private notes support with priority options
- Ability to summarize notes using various options
Optional Modules:
For company wide deployment or if you prefer a web-based solution for eCTD viewing capability consider
eCTDViewer Web Edition
