Prerequisites
Review with your IT Department:
Verify that the whitelisting settings are configured
Modify AS2 endpoint to deliver test submissions:
To allow connections to (sending) IP 15.205.247.22 and 3.31.183.245 over port 4080
To allow connections from (receiving) IP 150.148.0.0/16 over port 4080
Procedure
Open the FDA page: Setting up an AS2 Account Checklist.
Create/Locate your Letter of Non-Repudiation Agreement.
You must prepare this letter
(Note: if you were previously a WebTrader user and have already created the letter, that same letter can be used in this request as well).
FDA provides information and samples at this link.
Obtain Personal Certificate
FDA provides information on obtaining Digital Certificates
Certificate should be purchased in the name of the person that requested the ESG account. This user’s name, email address and certificate password will need to match configuration entered into Veeva at a later step.
The certificate should be marked as exportable when imported into the user’s System.
The user must record their password for the exported .pfx certificate.
The same certificate may be used for multiple environments (both Sandbox and Production)
The FDA Free certificate generation tool cannot be used for AS2 accounts
See Section 4 for detailed instructions on Importing and Exporting the Public and Private Keys.
Download FileCatalyst Transfer Agent
Ensure the user’s systems settings meet the following requirements:
Multi-core x64 CPU
8GB of RAM recommended on the machine
HDD or SSD with 10GB of install space for software
Confirm compatible operating system & web browser
From the USP portal - download the FileCatalyst Transfer Agent and install
Register for a NextGen AS2 Account
Go to ESG NextGen AS2 Account Set-up Steps to register for USP and establish an AS2 profile
Sign up for the correct user role as aligned with the necessary permissions as defined in the FDA ESG NextGen Unified Submission Portal Guide for Industry Users