Configure TraceLink

A Recall Admin User can use the Recalls Admin Settingsscreen to configure the following settings for the recalls network:

1. Select a [Customer-defined APT Network] from the network drop-down in the header.
2. Select a Team (e.g. your entire company or a Link to a specific Partner or internal location) in the header.
3. Select the Recalls Process in the header.
4. Select the Go button in the header.
5. Select the Configure Settings icon.
6. On the Settings tab, in the Enable Recalls section, select the Edit icon and fill in the following fields:
   1. Enable Recalls switch - Set to Yes to enable recalls.
   2. Select the Save icon.
      
7. In the Recall Product Categories section, select the Edit icon and fill in the following fields:
   1. Drugs check box – Indicates whether recalls that belong to the Drugs category are enabled.
   2. Biologics check box – Indicates whether recalls that belong to the Biologics category are enabled.
   3. Veterinary check box – Indicates whether recalls that belong to the Veterinary category are enabled.
   4. Devices check box – Indicates whether recalls that belong to the Devices category are enabled.
   5. Select the Save icon.
8. In the Configure Recall Responses section, select the Edit icon and fill in the following fields:
   1. Acknowledgment Response Due Days field – The number of days from recall creation date by which you want the recall to be acknowledged.
   2. Completion Response Due Days field – The number of days from recall creation date by which you want the recall to be completed.
   3. Share Configuration field – The approval mode for recall responses.
      See the options for the approval mode.

      • Autoshare – Automatically approves submitted recall responses.
      • Review and Share – Manually review and approve submitted recall responses.
   4. Select the Save icon.

The recall settings are configured for the entire recalls network.

When a new Partner or internal location is added to the recalls network, a Recall Admin User can use the Historical Sync tab to set the number of days from which recalls will be synced the new entities.

1. Select a [Customer-defined APT Network] from the network drop-down in the header.
2. Select a Team (e.g. your entire company or a Link to a specific Partner or internal location) in the header.
3. Select the Recalls Process in the header.
4. Select the Go button in the header.
5. Select the Configure Settings icon.
6. In the Days to Sync field, enter the number of days from which you want recalls to be synced.
   

   You can sync recalls up to a maximum of 90 days.

7. Select Sync.

The recalls will be synced for the number of days specified.

Partners can create compliance exceptions in Supply Chain Work Management either from the Web UI or by sending an email to TraceLink. To enable compliance exceptions via email, follow the steps to add an SMTP B2B connection in the Extensible TraceLink Transfer Help Center and ensure to correctly configure the fields below:

1. In the Client Email field, enter the email address set up to receive compliance exceptions.
2. In the Message Type drop-down, select Compliance Exception.
3. In the Network Name field, select the network on which you want to create the SMTP connection.
4. Select Copy on the Copy Email Address screen to copy the TraceLink email. You can use this email to define forwarding rules for your internal email.

For more information about SMTP B2B connections, see the Extensible TraceLink Transfer Help Center or contact the TraceLink implementation team for assistance in creating the SMTP B2B connection.

Tips

• Only an XTT Application Administrator can add an SMTP connection.
• To update the Client Email and Message Type fields for the connection, view the SMTP connection and select the Edit icon.

To enable exception creation through email:

1. Set up an internal email (for example: dscsaincidents@yourcompanydomain.com) to receive compliance exceptions. Trading partners who are not on the TraceLink network will send compliance exceptions to this email.
2. Set forwarding rules to this internal email such that all compliance exceptions received are automatically forwarded to the TraceLink email provided by XTT. See Add an SMTP B2B Connection in Extensible TraceLink Transfer for more information.

Tips

• Configure the internal email to include a list of email addresses or domains of trading partners from whom you want to receive compliance exception emails. This will reduce spam and redundant data creation in Supply Chain Work Management.
• TraceLink suggests to use an email format recommended by Healthcare Distribution Alliance. This will ensure consistency and reduce clutter. Supply Chain Work Management will create a compliance exception if the email has a subject line and description, but will not filter spam. See Draft a Compliance Exception Email for more information.

Compliance exceptions sent via email with a subject line and description will be created in Supply Chain Work Management and can be monitored by Owners and Partners in the Web UI. However, if a compliance exception is not created against an email sent, see the Extensible TraceLink Transfer Help Center for information about how to check for issues in the B2B connection.

• Application Administrator – Allows users to administer the Agile Process Teams app that the company owns by adding networks and assigning Network Administrators. This role also gives users the same access to Agile Process Teams as the Internal Member - Expanded Access role.
• Network Administrator – Allows users to administer Agile Process Teams networks by configuring the network (e.g. applying a specific solution, setting default due dates), linking Partners and internal locations to the network, and adding users directly to the network and assigning those users roles so they can access all Links within the network. This role also gives users the same access to Agile Process Teams as the Internal Member - Expanded Access role.
• Team Administrator – Allows users to administer teams of users within Agile Process Teams by accepting Link invitations and adding users to the Link and assign those users roles within the Link. This role does not give users access to the Agile Process Teams functionality. Team Administrators must also be assigned one of the member roles to take action in Agile Process Teams.
• Internal Member - Expanded Access – Allows users from the Owner to view, add, edit, copy, close, reopen, and export processes (e.g. incidents, change requests). Also allows users to submit processes to Partners and submit initial and final responses to processes, if supported. These users see the Expanded Access dashboard on the Monitor screens.
• Internal Member - Standard Access – Allows users from the Owner to view, add, edit, copy, and export processes. Also allows users to submit processes to Partners and submit initial and final responses to processes, if supported. These users see the Standard Access dashboard on the Monitor screens.
• Partner Member – Allows users from external Partners to view, add, edit, copy, and download processes. Also allows users to submit initial and final responses to processes, if supported. These users see the Standard Access dashboard on the Monitor screens, with information limited further for Partners.

• Process added - The users receive a notification when a process is added.
• Process | Follow Approaching Due Date - Users who follow the process receive a notification before the due date.
• Process | Follow is Closed - Users who follow the process receive a notification when a process is closed.
• Process | Follow is Commented On - Users who follow the process receive a notification when a new comment is added to a process.
• Process | Follow is Modified - Users who follow the process receive a notification when a process is modified.
• Process | Follow Past Due - Users who follow the process receive a notification after the due date.
• Process Submitted to Partner - The users receive a notification when a process is submitted to Partner.
• Compliance Exception Submitted to Partner - A Partner receives a detailed notification with all details about the compliance exception when the Owner submits the compliance exception to the Partner. The notification includes the following fields:
  • Summary
  • Description
  • Business Priority
  • Resolution Due Date
  • Incident Category
  • Reporter Company
  • Assignees at reporter company: Array Type
  • Accountable Entity
  • Assignees at Accountable Entity: Array Type
  • Associated Entities
    • Shipped From Business
    • From Business
    • Shipped to Business
    • To Business
  • Product Details
    • Product Identifier
    • Quantity details
    • Lot Number
    • Expiration Date
    • Serial numbers
  • Suspect product details (if applicable)
    • FDA Reported Date
    • Product Illegitimacy determined Date
    • Report type
    • Submitted through alternate mechanism
    • Report for notification termination
    • Drug composition
    • Notification Classification
    • Business Type
    • Incident Number
    • Product Label Name
    • Drug Use
    • Drug Description
  • Reference Transactions
    • Reference Transaction Type
    • Value
    • Reference Transaction Type
    • Value
• Recall Added - The users receive a notification when a recall is added.
• Recall Assigned to User - The users receive a notification when a recall is assigned to a user.
• Recall Comments Added - The users receive a notification when a comments are added for a recall.
• Recall Due - The users receive a notification on the recall due date.
• Recall Follow Up Message - The users receive a notification when a follow up message is received on a recall.
• Recall Past Due - The users receive a notification when the recall is past the due date.
• Recall Rejected - The users receive a notification when a recall is rejected.
• Recall Submitted for Review - The users receive a notification when a recall is submitted for review.
• Recall Updated - The users receive a notification when a recall is updated.