FDA ESG Publishing Gateway Setup

This page explains how to set up the FDA ESG NextGen UAT Gateway Connection for Veeva RIM Publishing. It is meant to be used in conjunction with the following FDA information:

FDA Guidance

• ESG NextGen AS2 Setup Instructions

• ESG NextGen Unified Submission Portal Guide

• Appendix G: Letters of Non-Repudiation Agreement

Note: Always refer to the FDA references prior to proceeding to ensure the latest guidance.

Preparation

The following information must be collected, as it will be provided to the FDA and into Veeva RIM for each configured environment.

• Account Name: Your Company’s Name

• Primary Contact Name*: Person the Certificate is registered to

• Primary Contact Email Address: Whomever the certificate is registered to

• RoutingID for Sandbox: Typically in this format: COMPANYNAMEABBREVIATIONRIMAS2SBX, for example, VVARIMAS2SBX

• RoutingID for Production: Typically in this format: COMPANYNAMEABBREVIATIONRIMAS2PRD, for example, VVARIMAS2PRD

• Delivery Exchange URL: Described in Vault User Account Setup/Configuration for Sandbox and Set Up Production Gateway for Production

Note: The Account Name and RoutingID must be different between the Sandbox and Production environments.

Sequence of Steps

Some of the steps in the work instructions below may be executed concurrently. This is indicated by the Prerequisites for each section. Otherwise, the work instructions are in the order in which they should be executed.

1. FDA ESG Help Desk Portal
2. FDA ESG AS2 Account Request
3. Vault User Account Setup/Configuration
4. Register Test Account
5. Finalize Test Gateway Profile Configuration
6. Prepare Test Submissions
7. Load Testing
8. Set Up Production Gateway