Getting_Started

Getting Started

This section concerns pre-installation requirements and assumptions for REVIEW users, as well as preliminary instructions for installing REVIEW.

System Requirements

Users should have a computer with the following:

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

• 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

The install file for REVIEW is found on your GlobalSubmit VALIDATE webpage. If you are unsure of where to find the VALIDATE site, or if any technical prerequisites have not been met, please contact your IT administrator or GlobalSubmit support.

Assumptions

Users should be familiar with:

• Windows operating system, including Windows Explorer

• The basics of eCTD submissions

Software Compatibility

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

Prerequisites: VALIDATE and the XFile

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