Managing notices

  1. Sign in as Item Lifecycle Coordinator or Item Lifecycle Administrator and click Manage Notices.
  2. Open a notice or click Create to create a new notice.
  3. On the Tasks tab, you can edit tasks, create manual tasks, or review tasks that are added automatically from the Product Transaction Query.
    • If a task is unassigned, or to assign a task to a different user, use the Reassign Task action.
    • If a notice is not related to a product that is tracked in the system, the product does not have any history or activity, or you require additional tasks, you can manually create ad hoc tasks.
      1. On the Tasks tab, select All Actions Menu > Helper List.
      2. From the list of users, select the responder for your new task.
      3. Click Attach Task.
      4. On Instructions, define the task priority, due date, and task instruction.
      5. Click OK.

    Some tasks that are not associated with a location, for example, agreement lines and procurement templates, are added to one large task. You must assign that one task to one responder or coordinator. In addition, if tasks do not have a responder, then they are combined in one large task. You must assign the task to one responder or coordinator. To break down a task, you or your Item Lifecycle Administrator can go back to your organization, add responders, and then re-run the Product Transaction Query.

  4. On the References tab, you can attach documents, links, or other identifiers to the notice.
    1. Click Create.
    2. Specify this information:
      Identifier Id
      Use this field to add other identifiers to the notice, such as FDA ID.
      Use As Working ID
      One ID can be specified as the working ID. This ID is displayed on all lists for reference or filtering.
      Link
      Use this field to add a link.
      File
      Use this field to add an attachment.
    3. Click Save.
  5. On the Comments tab, you can add comments for the notice. These comments are used primarily by the coordinator. Comments can include file attachments.
    1. Click Create.
    2. Specify Title and Comment text.
    3. Optionally, you can attach a file.
    4. Click Save.

    Comments can be added to a closed notice if additional information is received after it is processed.

  6. On the Domains tab, you can associate domains with the notice by selecting the HelperList.

    Assigning domains drives notifications based on the users within the assigned organization structure.

  7. On the Notifications tab, you can review and manage the list of users who will receive emails when the notice is released.
    General notification emails are different from tasks. They are more "for your information" and they do not include an activity that must be acknowledged and resolved before the notice can be closed.

    The notifications list is the list of responders and users who were indicated as watchers within the organization structure for the domains that are created on the notice. You can manage this list by adding or deleting individuals before you release the notice.

    If a user is a responder and they have no task, then the user receives a general notification email.

    If a user is a responder and they have a task, then an alert icon is displayed and the user will receive one task email.

    Notifications are sent, for example, task acceptance, task completion, notice closure, as determined by the Item Lifecycle Management Group setup.

    Notifications are not tied to the Product Transaction Query action.

  8. There are two ways to get users into the Notification tab:
    1. Attach Domain will bring in users regardless of whether transactions were found for their location.
    2. If Domains are not used, you can specify on the transaction query to pull in watchers. This will only pull in watchers/notification records if there are transactions for a location.