Pre-Installation_Information

Requirements

Users should have a computer with the following:

Any currently supported Windows operating system with .NET Full framework 4.0 or higher

Any modern browser such as Edge, Chrome, Safari

An installed application which supports .RTF or .CSV files for the reporting system

Adobe® Acrobat Standard or Adobe Acrobat Professional software, version 10.0 or higher

Any applications necessary to view other file formats that you include in your submissions, such as MS Word or a SAS viewer

For Publish: Adobe® Reader, Adobe Reader DC, or Acrobat software, version 10 or 11. (To make text based modifications to documents, Acrobat Standard or Pro is required.)

Note: If the following error is encountered after starting the application, check if Microsoft Edge Webview 2 Runtime is installed. If it is not, then install it and start the application again.

The system cannot find the file specified
(Exception from HRESULT: 0x80070002)

Assumptions

Users should be familiar with:

Windows operating system, including Windows Explorer

eCTD standard and guidelines

Software Compatibility

GlobalSubmit is compatible with all submission publishing software vendors that produce eCTD-compliant submissions. If the publishing software does not produce fully compliant eCTD submissions, the submission may not display as intended.

Your company must use GlobalSubmit Validate to initially load, or process an application before authors, regulatory operations, reviewers and others can use Desktop to view an application. Validate creates the .enx files (also called an XFile) required for Desktop to function. Once this occurs, both Validate and Desktop can be used simultaneously.

Permissions

After connecting to the webpage you will be prompted to enter a user name and password.

Depending on the permissions set by your administrators, the following privileges may be available:

CREATE FOLDER button

PROCESS button

LOAD Configuration page

Load Applications

Generate Reports

Validate Configuration page

Downloading content using the Download Queue

Printing single documents from within Desktop

Printing sets of documents using the Print Queue

Creating and viewing Public Annotations

Viewing validation reports

For Publish, if role-based security is enabled, a user must be granted publishing rights to perform any publishing activities. If role-based security is not used, any user can perform any standard or administrative publishing action.

If there are tabs mentioned in this documentation that are not showing, your user account may not have access to the specific tab or role. Please reach out to a local administrator or GlobalSubmit support.