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IBM Electronic Common Technical Document Viewer Description

A viewer for Electronic Common Technical Document (eCTD) submissions

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.

The Electronic Common Technical Document (eCTD) is a standard used by the FDA (United States Food and Drug Administration), European Agency for the Evaluation of Medicinal Products (EMEA), and other regulatory agencies in order to gain uniformity for a variety of electronic submissions. The IBM eCTD Viewer is an XML-based tool that assists in the processing of eCTD submissions. This tool allows pharmaceutical companies or regulatory agencies to "view" an eCTD submission that has been prepared using a separate eCTD "builder," such as the IBM Solution for Compliance in a Regulated Environment (SCORE) product. IBM SCORE 5.1.3 can be used to create, edit, and manage eCTD submissions. By using this viewer, the pharmaceutical company can ensure that the submission is readable before sending it to a regulatory agency.

The eCTD Viewer enables the user to:

* display and navigate through eCTD structures
* validate that
o eCTD backbone structure is correct
o MD5 checksums are correct
o documents are in the correct folder
o documents and directory names do not contain illegal characters
o document and directory names are not too long
o all files in the submission folder are in the backbone
* downloading of the whole submission as well as any of its parts
* batch printing of documents
* remembering favorite documents across submissions
* searching for documents.

How does it work?

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.

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