What's new ?

This page is intended to provide up-to date information about the ECPA eSubmission builder. The information heavily depends on the feedback of the users of the builder, so please share your findings:

  • Current scope and limitations
  • Known and reported bugs (please ghsts_supportatecpa [dot] eu (subject: Builder%20-%20Bug%20Report) (report bugs) to the development team)
  • Raised feature requests (please ghsts_supportatecpa [dot] eu (subject: Builder%20-%20Feature%20Request) (report feature request) for essential features)

If you are not sure about your observations, please ghsts_supportatecpa [dot] eu (subject: Builder%20-%20Support%20Request) (contact the eSubmission builder help desk).

Latest release

The latest release is version 0.9.1 released on June 8th, 2020.

If you use a previous version, please make sure to update before you report any errors. We may release patch versions if critical errors occur.

Current scope and limitations

The following limitations are known, a fix or extension was out of scope for the current release:

  • Potential installation issues may occur, as the eSubmission builder is provided as ZIP file and not as signed installation routine
  • The release is a single-user application, there is no support for multiple users and parallel usage
  • The application runs as standalone desktop application - architecture is prepared to scale up to enterprise application
  • The application allows you to publish incomplete information. You need to run a validator to verify, if the submission is technically correct
  • The content is stored be referencing the current local path when attaching a file to a document version. This means that the current path is stored in the eSubmission builder and there is no upload to a server-based content repository. The content must not be moved / deleted after attaching it to a document version.
  • Browser compatibility issues. Supported browsers are Chrome (preferred) and Internet Explorer 11. Known issues with other browsers are:
    • Microsoft Edge: top buttons disappear when selecting an item in a repository
    • Firefox and Edge: Expanding a large ToC beyond the available space destroys the pane setup of the two right columns
  • CADDY-xml import with best guess approach, due to possible degree of freedom in current usage of CADDY-xml.
    • Parsing of concentration and unit
    • No evaluation of replace and retired lifecycle changes
  • One ToC template available, no management of ToC templates
  • No functionality
    • to clone dossier version to new project or to ToC template
    • for an advanced search in repositories (e.g. document author)
    • to search for documents in a dossier
    • to define and use custom attributes, tagging, folksonomy
    • for the organisation of the document repository to scale with larger amount of documents
    • to display information in which dossier versions a document version is being used
    • for the computation all types GHSTS lifecycle information (the node assignment status is supported)
  • Support for usage with different database (currently H2 DB is being used). Application is prepared to work with other databases via JDBC connection
  • The eSubmission viewer is used to view a publication. When the viewer remains open and the dossier version is updated and then the viewer is called with the updated publication, this publication is not reloaded, as the filename does not change. A future change in the eSubmission viewer is required. As workaround please close the tab in the eSubmission viewer before reopening the updated dossier version.

Known bugs

  • duplicate entries in picklist "regulatory type"

Raised feature requests

  • extended search in document metadata (e.g. via author, owner, test laboratory)
  • generate a ToC template from a dossier version / from scratch / via import

Last update: June 9th, 2020