Set up an AS2 Connection and Transmission Profile to support submissions through the RZN Gateway.
About AS2 Connection Support for the RZN Gateway
Vault Safety supports electronic reporting to the Federal Service on Surveillance in Healthcare and Social Development (RZN) Gateway through AS2 (system-to-system) communication.
You must set up a Gateway Profile and a corresponding Transmission Profile for users to report cases to the RZN and receive gateway responses.
Prerequisite: Activate RZN as a Standard Organization
The RZN is a standard Agency provided with Vault Safety. However, in certain Vaults, an Admin must activate the Agency record.
Complete the following steps if the RZN is Inactive in your Vault:
- Go to Business Admin > Objects > Organizations.
- Open the Federal Service on Surveillance in Healthcare and Social Development (Russia) Agency record.
- From the All Actions menu, select Change State to Active.
Note: The Change State to Active user action appears only if configured by your Admin. Add User Action to the Organization Lifecycle provides instructions for this configuration.
Configure an RZN Account
Before you can configure the Vault Safety AS2 Connection, you must have an active RZN AS2 account.
Public and Private Certificates
As part of the registration process, you must obtain a public and private certificate pair and upload the public certificate to your RZN account. If you need help generating these certificates, contact Veeva Managed Services.
Create an RZN Transmission Profile
You must create a Transmission Profile of the type AS2 Gateway for the RZN. Manage Transmission Profiles provides instructions on setting up Transmission Profiles.
Note: For the RZN, the Transmission Profile API Name is hard coded to ucr_russia_gateway__c
.
Add a Submission Rule Set
Vault Safety comes preconfigured with the RZN as a standard Organization. To define Case criteria for Submissions to the RZN Gateway, you need to add a Submission Rule Set to the Organization record by completing the following steps:
- Go to Business Admin > Objects > Organizations.
- On the Organizations page, select Federal Service on Surveillance in Healthcare and Social Development (Russia).
- On the Federal Service on Surveillance in Healthcare and Social Development (Russia) page, select Edit.
- Under Details, in the Submission Rules field, select a standard Rule Set from the picklist.
- Select Save.
Note: Reporting Rule Sets provides more information about the available Rule Sets. If these do not fulfill your requirements and you need a different Rule Set, contact your Veeva Managed Services representative.
Result
The system can now auto-generate Submission records for ICSR Submissions to the RZN based on the Rule Set you selected.
Configure a Vault Safety AS2 Connection
- Go to Admin > Connections, then select Create.
- For the Connection Type, select AS2, then select Continue.
- Complete the AS2 Connection Fields.
- Select Save.
AS2 Connection Fields
Fields marked with a (*) are required.
Field | Description |
---|---|
Name* |
Enter a name for the AS2 Connection. This name must be unique in your Vault. |
API Name* |
Enter an API Name for the AS2 Connection. This name must be unique in your Vault. |
Contact Email* | Enter the Sender's Email |
Description | Enter a description for the AS2 Connection. |
AS2 Vault Gateway State |
The system populates this field with the current state of the AS2 Vault Gateway, which consists of one of the following options:
|
AS2 Encryption |
The algorithm the system uses to encrypt outbound AS2 messages and decrypt inbound messages. The system supports the following algorithms:
|
AS2 MDN Setting |
Whether the Message Delivery Notification (MDN) can be exchanged synchronously (Sync) or asynchronously (Async). For the RZN, select Async. |
AS2 Signature |
The method the system uses to sign outbound AS2 messages. The system supports the following signing methods:
|
AS2 Compress Before Sign |
If this option is selected, the system compresses messages before applying the Signing Algorithm. If this option is not selected, the system compresses messages after applying the Signing Algorithm. Note: We recommend leaving this option unselected. |
AS2 Additional ACK Stages |
If required, select one or more of the following options:
Note: We do not recommend using any additional ACK stages. |
AS2 Partner ID |
Enter one of the following RZN identification codes:
Whether you will be submitting Study or postmarket Cases, enter one of these values. You can specify the destination gateway endpoint in the Transmission Profile. |
AS2 Partner URL |
Enter one of the following destination RZN Gateway URLs:
|
AS2 Partner Certificate Expiry | The system automatically populates this field when an Admin uploads the Partner Certificate. |
AS2 Vault ID | Enter the sponsor ID registered with the RZN. This value is the same as the customer's Routing ID you provided when setting up your RZN account. |
AS2 Vault URL |
Enter the AS2 URL of your Vault in the following format, replacing https://<SponsorName><Partner><Environment>.gateway.veevavaultsafety.com:4080/api/v1/inbound/transmission/
The following example demonstrates how to form the AS2 Vault URL for a Vault with the following values:
|
AS2 Vault Certificate Expiry | The system automatically populates this field when an Admin uploads the Sponsor Certificate. |
Upload the Partner and Sponsor Certificates
Vault Safety uses the Partner and Sponsor certificates to communicate securely with the Partner.
- Partner certificate: You will have received the Partner certificate as part of creating your account with the Partner.
- If you need help generating a Sponsor certificate, contact Veeva Managed Services.
Upload Partner Certificate
- From the All Actions menu, select Upload Partner Certificate.
- Select Choose, then select the Partner’s Public Certificate.
Accepted formats: PKCS7 (.p7b
or.p7c
), DER (.cer
or.der
) and PEM (.cer
,.crt
, or.pem
)
Vault checks the expiry date of the certificate. If the certificate is no longer valid, you cannot save the record.” - Select Continue.
Upload Sponsor Certificate
- From the All Actions menu, select Upload Sponsor Certificate.
- Select Choose, then select the Sponsor’s Public Certificate.
Accepted formats: PKCS12 (.pfx
or.p12
)
Vault checks the expiry date of the certificate. If the certificate is no longer valid, you cannot save the record. - Select Continue.
Add Connection Allowed IPs
Specify one (1) or more Allowed Connections for the AS2 Connection. These are Internet Protocol (IP) addresses that the system will allow to connect with this AS2 Connection.
Note: To obtain the latest list of allowed connections for the RZN, contact Veeva Managed Services.
Perform the following steps for each Allowed Connection you want to add to the AS2 Connection:
- Go to the Connection Allowed Lists section, then select Create.
- Enter the Name, (optional) Description, and IP address of the Allowed Connection.
Ensure the format of the IP address isXX.XX.XX.XX
orXX.XX.XX.XX/{subnet mask}
where the{subnet mask}
is a number between 24 and 32. - Repeat steps 1 and 2 for each Allowed Connection.
- When you have added all the Allowed Connections, select Save.
Note: By default, Vaults are limited to 512 Allowed Connections. If your organization requires more, contact Veeva Managed Services.
Synchronize the Connection
Once you have entered all the details of the AS2 Connection, the Connection must be synchronized with the Gateway.
From the All Actions menu, select Sync Connection to Gateway.
When the system successfully completes this action, the Connection’s AS2 Vault Gateway State changes to Registered and the system can send and receive messages using this Connection.
Note: If the Sync Connection to Gateway action is not successful, ensure the value of each of the AS2 Connection fields is correct before retrying the action again. If the issue perists, contact Veeva Managed Services.
If you make any changes to the Connection object or its Connection Allowed List, the AS2 Vault Gateway State changes to Registered - Out of Sync. The system cannot send or receive any messages using this Connection while it is in the Out of Sync state. You will need to repeat the All Actions > Sync to Gateway action to restore the Connection to the Registered state.
Result
The RZN AS2 Connection is active and available to use to submit case reports to the RZN.
Configure Transmission Lifecycles and Workflows
We recommend that you configure Transmission lifecycles and workflows to align with your organization’s standard operating procedures. The following items are best practices and recommendations:
- Configure a Case Transmission Error workflow to handle Transmission errors.
- Configure a workflow to prevent a Transmission record from entering a Ready for Submission state until a Transmission Profile is specified.
About Object Lifecycles and About Object Workflows provide more information about configuring lifecycles and workflows.