This Help Center is a preview of a future release. The final Help Center will be available on the Validation date.

Work items

Work items facilitate collaboration and data exchange across multiple enterprises or partners. They are specifically built to support use cases where interaction between separate businesses, partners, or stakeholders is required. Work items provide shared visibility into key data and processes for all participating enterprises while ensuring security, access control, and traceability.

Work items can be used in situations where two companies collaborate on a shared task with strict deadlines, such as tracking the supply of life-saving medication for a hospital network. For example, the Owner (Pharmaceutical Formulator) is manufacturing a batch of life-saving medication that a Partner (Hospital Network) requires for an upcoming patient treatment program. The Owner is responsible for manufacturing, quality control, and packaging of the medication. Once ready, the medication needs to be shipped to the Partner, who requires the product to be on-site within 10 days to prepare for patient administration.

Both Owner and Partner must collaborate closely to ensure that the Owner meets production and packaging deadlines while the Partner prepares for immediate distribution to hospitals. Timely updates and coordination are vital to ensuring the medication arrives on time, meets quality standards, and is available for patient use without delay.

Create a work item

Create and configure a work item to track internal operations or to collaborate with an external partner and exchange data.

  1. Select a [POET 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 Work Item from the left menu.
  4. Select the New button.
  5. In the General section fill in the following fields:
    1. Title field – The title of the new work item.
    2. Due Date field – The date by which the work item must be completed.
  6. Select the Save button.
    The work item is created in the Draft state.
  7. To move the work item to To Do state, select the Move to button.

Tips

  • Configure a prefix for work item when setting up Process Orchestration for Empowered Teams. For more information about configuring prefixes, see Specify prefixes for display identifiers.

  • If a Partner creates a work item, they do not have the option to add an Assignee company, as the Assignee company is set to the Owner's company by default.

  • In the Comments and Attachments section, do one of the following
    • Select the Add icon, to add comments and attachments.
    • Select the Delete icon, to remove comments and attachments.
  • Attachments cannot be added without a comment.

Compliance exceptions is a sub-type of the Work Item business object and contains fields that are specific to compliance exceptions. By default, a compliance exception is created by a set of basic fields, which are widely used. However, depending on your business needs, you may need to include additional fields in the compliance exception. To include additional fields, edit the compliance exception to view all available fields and update the required fields.

  1. Select a [POET 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 Compliance Exception from the left menu.
  4. Select the New button.
  5. In the General section fill in the following fields:
    1. Title field – The title of the new compliance exception.
    2. Business Priority field – The level of priority for the compliance exception. Select from Low, Medium, High, and Critical.
    3. Category field – The category of the compliance exception.
  6. Select the Save button.
    The work item is created in the Draft state.
  7. To move the work item to To Do state, select the Move to button.

Owners and Partners who are on the TraceLink network but do not use the Web UI can create a work item by sending an email in a pre-defined format. To enable work item creation through email, Owners and Partners must follow the steps listed below:

  1. Create an SMTP B2B connection in Extensible TraceLink Transfer, which generates a unique TraceLink email (e.g. apt_owner_6bba37c60eeb56@tracelink.com). For more information about adding an SMTP B2B connection, see the Extensible TraceLink Transfer Help Center.
  2. Share the TraceLink-generated email address (e.g. apt_owner_6bba37c60eeb56@tracelink.com) with a TraceLink Service Representative to map the email address with Process Orchestration for Empowered Teams.

Draft a work item email

When creating a work item by sending an email, the subject line of the email will be used as the title of the work item and the body of the email will be added as a comment to the work item.

The information captured from the email to create work items and subtypes is not HDA compliant. TraceLink will introduce HDA compliant email format for work items in a future release.

Modify a work item

Edit a work item and its sub-types, close a work item and its sub-types that are complete, or delete a work item and its sub-types that are no longer required.

  1. Select a [POET 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 Work Item from the left menu.
  4. Select the Display Identifier of the work item to edit.
  5. Select the Edit button.
  6. Update the required information.
  7. Select the Save button.
    The work item is updated.
Owners can edit the Assignee Details section while the work item is in the Draft state. Once the work item moves to the To Do state, the Assignee Details section can be edited only once.
  1. Select a [POET 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 Compliance Exception from the left menu.
  4. Select the Display Identifier of the compliance exception to edit.
  5. Select the Edit button.
    In addition to the fields updated when creating the compliance exception, additional fields will be displayed which can be updated if required.
  6. In the General section update the following fields:
    1. Title field – The title of the new compliance exception.
    2. Due Date field – The date by which the work item must be completed.
    3. Business Priority field – The level of priority for the compliance exception. Select from Low, Medium, High, and Critical.
    4. Business Unit field – The business unit for the compliance exception.
    5. Category field – The category of the compliance exception.
    6. Sub Category field – The sub category of the compliance exception.
    7. Description field – The description of the new compliance exception.
  7. If you require to collaborate with an external partner, enter the following Assignee Company details under the Participants section:
    1. Business Name field – The name of the Partner company that is assigned to take action on the compliance exception.
    2. Identifier Type field – The type of document that is associated with the compliance exception, such as Purchase Order, Invoice etc.
    3. Identifier Value field – The identifier value document associated with the compliance exception, such as PO number, Invoice number, etc.
  8. You can specify an accountable entity at the Initiator Company or Assignee Company in the Accountable Entity section:
    1. (Responsible User At Initiating Company) User Email field – The email of the Initiator Company that is required to take action on the compliance exception.

    2. (Responsible User At Assignee Company) User Email field – The email of the Assignee Company that is required to take action on the compliance exception.

  9. If you need to add delivery details, update the following fields under the Delivery Information section:
    1. (From Business) Business Name field – The name of the business that sent the consignment.
    2. (From Business) Primary Identifier Type field – The type of document that is associated with the compliance exception, such as Purchase Order, Invoice etc.
    3. (From Business) Primary Identifier Value field – The identifier value document associated with the compliance exception, such as PO number, Invoice number, etc.
    4. (To Business) Business Name field – The name of the business that received the consignment.
    5. (To Business) Primary Identifier Type field – The type of document that is associated with the compliance exception, such as Purchase Order, Invoice etc.
    6. (To Business) Primary Identifier Value field – The identifier value document associated with the compliance exception, such as PO number, Invoice number, etc.
  10. If you need to add shipping details, update the following fields under the Shipped from Business section:
    1. (Shipped From Business) Business Name field – The name of the business that sent the consignment.
    2. (Shipped From Business) Primary Identifier Type field – The type of document that is associated with the compliance exception, such as Purchase Order, Invoice etc.
    3. (Shipped From Business) Primary Identifier Value field – The identifier value document associated with the compliance exception, such as PO number, Invoice number, etc.
    4. (Shipped To Business) Business Name field – The name of the business that received the consignment.
    5. (Shipped To Business) Primary Identifier Type field – The type of document that is associated with the compliance exception, such as Purchase Order, Invoice etc.
    6. (Shipped To Business) Primary Identifier Value field – The identifier value document associated with the compliance exception, such as PO number, Invoice number, etc.
  11. In the attachments section, add a supporting document for the compliance exception under Documents.
  12. In the Impacted Products section, add product information in the following fields:
    1. Product Name field – The name of the impacted product.
    2. Lot Number field – The lot number of the impacted product.
    3. Primary Item Code Type field – The item code type of the impacted product.
    4. Primary Item Code Type field – The item code value of the impacted product.
    5. Product GTIN field – The GTIN of the impacted product.
    6. Expiration Date field – The expiration date of the impacted product.
  13. In the Transaction ID section, add information about the transaction in the following fields:
    1. Reference Transaction Identifier Type field – The type of transaction associated with the impacted product, such as Purchase Order, Supplier Order, Delivery Receipt.
    2. Transaction Identifier Value field – The ID of the transaction for the impacted product.
  14. In the Suspect Product section, add detailed information about the impacted product in the following fields:
    1. Drug Composition field – The composition of the impacted product.
    2. Incident Number field – The incident number associated with the impacted product.
    3. Product Label Name field – The product label name of the impacted product.
    4. Request For Notification Termination field – Request for notification termination for the impacted product.
    5. Business Type field – The business type of the impacted product.
    6. Drug Description field – The description of the impacted product.
    7. Drug Use field – The use of the impacted product.
    8. Notification Classification field – The notification classification of the impacted product.
    9. Report Type field – The report type of the impacted product.
    10. Submitted Through Alternate Mechanism field – Indicated if the impacted product was submitted through an alternate mechanism.
    11. Date Product Identified As Illegitimate field – The date when the impacted product was identified as illegitimate.
    12. Initial Notification Date To FDA field – The initial notification date to FDA for the impacted product.
  15. In the Comments and Attachments section, add a comment in the Comment Text field and name of the user in the Commented By field, or attach a file under Attachment.
  16. Update the required information.
  17. Select the Save button.
    The work item is updated.
Owners can edit the Assignee Details section while the work item is in the Draft state. Once the work item moves to the To Do state, the Assignee Details section can be edited only once.

When the work item's investigation is complete and an acceptable final response has been provided, the work item can be moved to the Done state from the To Do or In Progress state.

  1. Select a [POET 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 Work Item from the left menu.
  4. Select the Display Identifier of the work item.
  5. Select the Move to button under the Done state.
    The work item will be moved to the Done state.

When a work item is no longer required or created incorrectly, it can be deleted.

  1. Select a [POET 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 Work Item from the left menu.
  4. Select the work item row from the list.
  5. Select the Delete button.
  6. Select Apply on the confirmation prompt.
    The work item will be deleted.
A work item cannot be recovered once it is deleted.

Monitor work items

Monitor work items and its sub-types at a high level to understand the state of all work items that you have access to.

  1. Select a [POET 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 Work Item from the left menu.
  4. Select the Filter button.

  5. In the Filters panel, fill in one or more of the following fields to filter the results:

    1. Display Identifier field – The display identifier of the work item.

    2. State field – The state in which the work item is, such as Draft, To Do, In Progress, or Done.

    3. Due Date field – The date by which the work item must be completed.

    4. Initiator Company field – The company that has created the work item.

    5. Assignee Company field – The company that the work item is assigned to.

    6. Title field – The title of the work item.

    7. Last Modified field – The period of time in which the work item was last updated.

  6. Select Apply.
    A list of work items is displayed based on the filter results.