Procedure
Determine if a No Expiration Security Policy already exists (if not, one will need to be created).
If there isn’t already a Security Policy available that allows for no password expiration, you will need to create a new one
(Note: you must be a Domain Admin to create a Security Policy).If this step is not completed, the ESG connection will fail when the password expires in accordance with your existing password policy.
Example (if no policy already exists):
Create an FDA ESG User.
Create a new user called FDA ESG and configure it to use the FDA ESG Login Only Security Profile and the No Expiration Security Policy described above.
The email of the user MUST be a valid customer email account.
This user account allows the FDA to send Acknowledgement (Ack) messages back to Veeva RIM.
You will eventually need to create the equivalent user in Production – there will be one account for your Sandbox Vault domain, and another account for your Production environment domain (for example: fda.esgTEST@sb-veevapharm.com for your Sandbox environment, and fda.esg@veevapharm.com for your Production environment).
The account(s) being set up in Sandbox and then later in Production will need to have their passwords set initially.
When creating the user account, use an email address of someone who can login and set the password for the FDA User Account (Can be IT or Regulatory/Other). This email address does not have to match the certificate email address.
This user will receive an email to login and reset the account password once the account is created.
Ensure the following is documented and collected for the FDA ESG User Account as it must be sent to the FDA during registration:
Username
Password Important, or the password will need to be reset. Be sure to retain this password.
NOTE: Ensure the password has been set and that you can log in successfully using the new credentials. When testing the login, take note that a page will be displayed stating “Page not Found”. This is due to restricted security settings on the account and is working as intended.
Copy the Vault AS2 URL (will be needed to complete a later step):
Navigate to Admin > Settings > Gateway Profiles
Click on the US FDA Async ESG profile
In the Profile Configuration section, click Copy URL
