You can transmit individual case safety reports from Vault Safety to AS2 Gateway endpoints.
Note: Depending on your Admin’s configuration, object, field, and section labels, lifecycle states, and workflows may differ from the general information on this page. Refer to your organization’s business processes for guidance.
What is AS2 Gateway Communication
Vault Safety supports AS2 interchange to communicate with trading partners and regulatory authorities. AS2 is a secure electronic data transmission protocol between two trading partners (gateways) through the Internet. Vault Safety can direct E2B transmissions to regulatory agencies and custom AS2 gateways.
The following graphic shows the steps that occur when Vault Safety sends an E2B transmission to a regulatory agency gateway or trading partner.
- Vault Safety generates the source E2B XML file.
- Vault Safety affixes a digitial signature and sends the encrypted E2B message.
- The message is sent to the destination gateway and ACK1 is returned to Vault Safety.
- Upon receipt of the message, the destination gateway sends an MDN.
- The destination gateway decrypts the message and receives the E2B file.
- The destination gateway sends the final ACK once the E2B is accepted.
- Vault Safety receives the final ACK and moves the Transmission to the ACK Accepted state.
Note: The above diagram shows the process for asynchronous AS2 transmissions, used for EMA E2B(R3) and FDA VAERS E2B(R3). For synchronous AS2 transmissions, used for FDA E2B (R2), the MDN (step 4) is returned to Vault Safety using the same HTTP connection as the initial transmission (step 3).
Send a Gateway Transmission
To complete the ICSR Gateway Transmission, review the Transmission record and attachments to verify they are correct, and then trigger the Submit to Gateway action.
Prerequisites
- The Transmission must be created, either as a Submission or Distribution.
- Your Admin must have configured the Gateway Connection and Transmission Profile for the destination organization.
- You must have permissions to manage Submissions and Distributions. Typically, this is reserved for the Distribution Manager role.
Submit to Gateway Action
Use the Submit to Gateway action to send Submissions and Distributions with a System Gateway or AS2 Gateway Connection with a Transmission Profile.
Note: If the Validation Status for the Submission is Hard Fail, the Submit to Gateway action will not run. Your Admin can configure the Result Status Type to Hard Fail for certain Validation Criteria.
When you trigger the Submit to Gateway action, the system automatically regenerates the E2B Transmission Document, assigns an E2B Message ID, and updates the Transmission Date field.
Depending on your Admin’s configuration, this action may be available as a user action on Transmissions or triggered automatically as part of a workflow.
The system sends the submission to the destination AS2 Connection or Gateway configured in the corresponding Transmission Profile. Once complete, a notification appears on the Home tab under Notifications with the status of the submission.
Note: If you use Auto-Submissions to multiple destinations that are triggered automatically as part of a workflow, you can configure the Async Submit to Gateway feature to improve the performance of your Vault when sending transmissions. See the Async Submit to Gateway enablement article for details.
Review the Transmission Document
- Go to the Transmission. Find Transmissions under the relevant Case or from the Transmissions tab.
- Beside File select the file link. The document appears in a new page.
- From the
menu, select Source Document. The system downloads the XML file. - When the download is complete, open the file to review the ICSR.
Regenerate the Transmission Document
If the Case or Transmission changes, regenerate the transmission document.
- Go to the Transmission. Find Transmissions under the relevant Case or from the Transmissions tab.
- Expand the All Actions menu, and then select Generate Transmission Document(s).
Result
The system generates a new version of the document and updates the File field.
Types of Gateway Responses (ACKs and MDNs)
Every gateway transmission returns responses which indicate the success or failure of the transmission. These responses can be a Message Delivery Notification (MDN) or an Acknowledgment (ACK).
When a Vault Safety gateway transmission is sent, MDN and ACKs from the trading partner are added as Transmission Messages referenced by the outbound Transmission (Submission or Distribution).
The following articles provide more information on inbound ACKs and MDNs:
- Resolve Gateway Issues provides the steps to view gateway response messages.
- Standard Agency ICSR Submissions describes how Vault Safety maps agency MDNs and ACKs to Vault Safety’s response labels (ACK 1–4) and Transmission lifecycle states.
See the following section for more information on the standard Transmission lifecycle states.
Transmission Lifecycle States for Gateway Transmissions
Note: This page describes the standard Transmission lifecycle states. If your organization has a custom lifecycle state configuration, follow the recommendations in your business standard operating procedures.
| Lifecycle Stage Group | Lifecycle State | Description |
|---|---|---|
| Pending | Ready | Ready is the initial stage and state of a Transmission for which the Auto-Submit field was set to a value. Auto-Submissions provides more information. |
| Pending | Pending | Pending is the initial stage and state of a Transmission for which the Auto-Submit field was not set to a value. The system assigns a task to review and approve the Transmission and ICSR E2B file. |
| Pending | Validation Error | Vault Safety found errors during the E2B XML validation process. |
| Pending | Ready for Submission | The transmission and transmission document have been reviewed and approved, and the system has queued the transmission for sending to the destination gateway. |
| Sending | Sending ICSR | The transmission has been sent but the destination gateway has not sent an acknowledgment message yet. |
| Sent | Sending Attachments | Vault Safety is receiving an acknowledgment message from the destination gateway. |
| Sent | Error | Vault Safety could not send the transmission. |
| Sent | MDN Received[1] | The transmission was acknowledged by the destination gateway. |
| Sent | MDN Failure[1] | The transmission could not be delivered to, or acknowledged by, the destination gateway. |
| Sent | E2B ACK Warning | Vault Safety received the final ACK message indicating the destination gateway could not load the transmission. |
| Sent | E2B ACK Rejected | Vault Safety received the final ACK message with an error indicating the destination gateway loaded the transmission but rejected it, likely due to an issue in the E2B file. |
| Accepted | E2B ACK Accepted | The system received the final ACK message indicating the destination gateway accepted the E2B file and the transmission is complete. Note that the final ACK may still contain data warnings in this state. |
| [1] This Lifecycle State does not apply to AS2 Connections. | ||