IBM Electronic Common Technical Document Viewer
A viewer for Electronic Common Technical Document (eCTD) submissions and a tool that helps with the configuration of the IBM Solution for Compliance in a Regulated Environment (SCORE) product.
Date Posted: April 9, 2004
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eCTD Viewer:
The eCTD specification is still an evolving specification: Worldwide agencies are working towards the Module 1 specification, and the ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) is making updates to the eCTD specification. The eCTD page of the FDA/Center for Drug Evaluation and Research Web site provides further information.
With eCTD Viewer, the user can build an eCTD using an application specifically designed for that purpose. Such work would normally entail selection of files for the various eCTD modules, rendering of the files to Portable Document Format (PDF)® (as needed), and then packaging of the files into the eCTD "folder" structure.
The IBM eCTD Viewer, which makes use of Internet Explorer 6.x or above and the eCTD DTDs, can be used to examine a submission built according to the ICH specification.
SCORE Configuration Editor:
A customer who has an IBM SCORE installation can export the configuration of an IBM SCORE repository and then import the configuration zip file into the IBM SCORE Configuration Editor, where he can edit the configuration, validate the configuration, and export the configuration zip file from the IBM SCORE Configuration Editor; this file can then be imported back into the IBM SCORE repository.
Installation instructions
IBM eCTD Viewer:
- Download and run ibm_ectd_viewer_1_5_x.msi (requires Microsoft Windows Installer 3.1 or above).
- Restart the system (if necessary).
SCORE Configuration Editor:
- Download the zip file and unzip the contents to the C:\ drive. (Due to the Windows limitation on the length of file paths, errors may be encountered during the unzipping process if you attempt to unzip the contents to another location, such as the desktop. If, during the unzipping process, a message panel asks for a password for a password-protected file, please restart the unzipping process, unzipping to a different location.)
- In order to launch the editor, run the Configuration Editor.exe file.
Additional information is included in the readme.txt file.
Adobe, Acrobat, Portable Document Format (PDF), and PostScript are either registered trademarks or trademarks of Adobe Systems Incorporated in the United States, other countries, or both.
Microsoft, Windows, Windows NT, and the Windows logo are trademarks of Microsoft Corporation in the United States, other countries, or both.
IBM is a trademark of IBM Corporation in the United States, other countries, or both.
Other company, product, or service names may be trademarks or service marks of others.
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