Set Up Production Gateway

Prerequisites

• Complete all preceding Test Gateway steps for the Sandbox environment

• Receive email from the FDA indicating that you are approved for a Production Account

• The Veeva Publishing application is active in your Production Vault.

The FDA must have provided you with the following:

• .P7B Certificate for Production

• Health Authority ID ZZFDA

• Healthy Authority URL https://upload-api-esgng.fda.gov:4080/as2/receive

Procedure

1. Production FOLLOW-UP

   Next steps:

   • Wait for instructions from the FDA regarding the Production account.

2. Create FDA ESG User / Security setup in Production. Follow Steps listed in Section 2.3.1.

   This includes:

   • Confirming Security Policy (No Password Expiration)

   • Creating FDA User Account

     • Resetting & Recording Password for FDA User Account

   Please note, the FDA will need the Production Username and Password to successfully login to the Production Environment.

3. Copy Production Vault AS2 URL

   FDA ESG User Login Information and Vault AS2 URL

   • This info is needed to complete the registration below.

   • The Vault AS2 URL. To acquire your Production Vault’s AS2 URL:

     • Navigate to Admin > Settings > Gateway Profiles

     • Click on the US FDA Async ESG profile

     • In the AS2 Profile Confirmation section, click on the Copy URL button to grab the Vault AS2 URL to be provided during registration.

   

4. Following the successful transmission of a Test Submission, FDA will respond via email and provide guidance as applicable. To finalize the Production configuration you still need to:

   • Install the FDA Public Production Certificate as provided in the AS2 guide

   • Utilize the Production URL

   Update the Routing ID: Note that this must be different than the Routing ID that was used for Sandbox.

5. The following steps in the Production environment include:

   • Editing the FDA Async Gateway with Production Information

   • Setting the Gateway Profile to Active

6. Access US FDA Async ESG Gateway Profile

   • Navigate to Admin > Settings > Gateway Profiles

   • Click on the US FDA Async ESG profile. Select Edit.

   

7. Enter fields:

   NOTE: People often copy and paste values here. LEADING & TRAILING SPACES MAY CAUSE FAILURES.

   • Description

   • Sponsor Email Address: Enter same as used in the FDA account application form

   • Sponsor Certificate: Upload your digital certificate (the .pfx file exported in Step 5 of Section 2.2.2 .

   • Sponsor Certificate Password: Enter certificate password

   • Sponsor Certificate Expiration Date: The system will look this up from the certificate

   • Sponsor ID: Your Routing ID that was used to register

8. Enter fields:

   

   • Health Authority Certificate: This is provided in the account activation email from the FDA].p7b

   • Health Authority Certificate Expiration Date: The system will look this up from the certificate

   • Health Authority ID: This is provided in the account activation email from the FDA

   • Health Authority URL: This is provided in the account activation email from the FDA

   • Gateway User Required: Do not check this

   • Gateway User: Leave blank

   • Encryption Algorithm: Leave blank

   • Signing Algorithm: Leave blank

9. After saving in step 3, set the profile to ACTIVE (Using the Set Active button). This must be done anytime the profile is edited.

10. Review the Production Environment Details from the original form sent to the FDA when you registered your test account. Confirm the details correspond to the information in your Production Vault.

    	Production Environment Details
    ESG NextGen USP Information	Email address associated with profile registered on USP
    Routing ID	(Typically in this format: COMPANYNAMEABBREVIATIONRIMAS2PRD, for example, VVARIMAS2RIMPRD, can be the registered RoutingID)
    Gateway HTTPS URL (only ports 443, 4080 are accepted)	(Described in Vault User Account Setup/Configuration for Production)
    Gateway Credentials (if applicable)	FDA User Login at Veeva. (Described in Vault User Account Setup/Configuration)
    Point of Contact Name for Account (First and Last)	Point of Contact Name for Account (Whoever the Certificate is registered to)
    Point of Contact Email for Account	Point of Contact Email for Account (Whoever the certificate is registered to)
    Attach Signing Certificate	This should be the certificate provided in original form and should not be changed
    Attach Encryption Certification (if different)	N/A
    SSL certificate	N/A: ESG NextGen does not pin SSL certificates, therefore this is not needed.
    Whitelist IPs	N/A: ESG NextGen does not need to know IPs for whitelisting.

11. If URL or Credentials submitted in original form differs from the URL or Credentials in Production Vault, open a support ticket with the FDA by sending the updated form to ESGNGSupport@fda.hhs.gov.

    Use the following text in the email body:

    Please update the URL and credentials for existing connection for Production Environment as per the updated form attached.

12. Wait for confirmation from the FDA.