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Software > Assembly & Publishing > EZsubs: Features & Benefits |
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EZsubs: Features & Benefits
Overview > Features & Benefits > Technical
Specification
Features
- Electronic document publishing solution for regulatory submissions
- Creates a new submissions structure based on supplied, pre-defined templates for multiple country submissions (US, EU, Japan & Canada)
- Supports both the Common Technical Document (CTD) and the electronic CTD (eCTD)
- Supports the latest regulatory requirements for:,
- For eCTD module 1, defined by regional bodies: US–FDA 2.01; Japan–MHLW 1.0; EMEA–1.0, 0.92 and 0.9
- For eCTD modules 2 to 5, defined by ICH: US support for Study Tagging Files and File ID; Japanese, documents with JP titles and
attributes
- EZsubs templates for eCTD EU 1.0 ICH 3.2, eCTD US 2.01 ICH 3.2 and eCTD JP 1.0
- ICH 3.2
- Study Tagging Files (STF) for the FDA
- Enables publishing finishing options, such as the addition of headers, footers, watermarks, pagination, etc.
- Creates and edits bookmarks, table of contents, table of tables, and table of figures
- Creates and edits tabsheets. Enables preview before printing.
- Publishes a Virtual Document for paper output or electronic output
- Creates and edits cross references into Word and PDF documents, and resolves cross references during publishing
- Rapid volumization for large paper-based submissions
- Comprehensive facilities to support paper publishing such as automatic volume compilation, printer control commands, page size and
orientation normalization, foldout handling, binding margin adjustment and support for double-sided printing.
- Exports and imports file structures and documents to and from the Documentum docbase to a Windows file system
- Provides a viewing tool to view the publish / XML
- Localised into English and Japanese
- Fully integrated with Documentum
Benefits
- Proven, industry leading solution used by leading Pharmaceutical companies
- Faster time to submission with automated publishing process
- A single solution to compile compliant submissions in both electronic and paper format
- Assured compliance with the latest regulatory guidelines and specifications
- Simultaneous submissions to multiple agencies achieved by comprehensive built-in templates
- Reduced resource requirement for submission preparation with automated tools to support paper publishing
- Increased productivity with powerful tools for fast resolution of electronic cross references between documents and volumes for electronic
submissions
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