FAQs

General

All members of the supply chain, from Suppliers to Pharmacies and Hospitals, can use Agile Process Teams to collaborate on incidents , change requests, recalls, and document reviews. However, some Agile Process Teams processes are built to support specific use cases:

  • Incidents – Suppliers, Manufacturers, CMOs, CPOs, 3PLs, and Repackagers can collaborate with their Partners, as well as their own internal locations, to capture a variety of issues and disruptions.
  • Incidents - Direct Supplier – Suppliers, Manufacturers, CMOs, CPOs, 3PLs, and Repackagers can collaborate with their Partners, as well as their own internal locations, to capture a variety of direct supplier issues and disruptions (i.e. incidents that involve materials to manufacture the product).
  • Incidents - External Manufacturing – Suppliers, Manufacturers, CMOs, CPOs, 3PLs, and Repackagers can collaborate with their Partners, as well as their own internal locations, to capture a variety of external manufacturing issues and disruptions.
  • Incidents - Compliance Exception – Suppliers, Manufacturers, CMOs, CPOs, 3PLs, Repackagers, Wholesale Distributors, and Dispensers as well as their own internal locations, to capture a variety of supply chain deviations for product that originates in the United States and report suspect product to the FDA.
  • Document Reviews – Suppliers, Manufacturers, CMOs, and Repackagers can collaborate in real time with their Partners, as well as their own internal locations, to review and approve general documents (e.g. audit reports).

As noted above, the Incident, Change Requests, and Document Reviews processes can be used by any member of the supply chain.

Partner companies and locations that link to Agile Process Teams can only view a specific subset of data for each process. See Track and resolve incidents, Request and implement changes, and Review and approve documents for the specific data limitations of the processes.

Yes. Companies that own Agile Process Teams and Opus Solution Environment (OSE) can also customize the pages, workflows, roles, and policies used by APT. Contact TraceLink Support for more information. For more information on solutions and configuring solutions for an app, see the Opus Solution Environment Help Center.

The following Agile Process Teams events are captured in the Track & Trace Services audit trail:

functionalArea businessObjectType action Description
Agile Process Teams
  • Incidents
  • Incidents - Direct Supplier
  • Incidents - External Manufacturing
  • Incidents - Compliance Exception

Add Incident - Save

 Captures when users at the Owner add a new incident.
Agile Process Teams
  • Incidents
  • Incidents - Direct Supplier
  • Incidents - External Manufacturing
  • Incidents - Compliance Exception
Add Incident - Submit to Partner Captures when users at the Owner submit a new incident to the Partner.
Agile Process Teams
  • Incidents
  • Incidents - Direct Supplier
  • Incidents - External Manufacturing
  • Incidents - Compliance Exception
Add Incident - Partner Added Captures when users at the Partner add a new incident.
Agile Process Teams
  • Incidents
  • Incidents - Direct Supplier
  • Incidents - External Manufacturing
  • Incidents - Compliance Exception
Edit Incident - Save Captures when users edit the incident.
Agile Process Teams
  • Incidents
  • Incidents - Direct Supplier
  • Incidents - External Manufacturing
  • Incidents - Compliance Exception
Edit Incident - Submit to Partner Captures when users at the Owner edit the incident and submit it to the Partner.
Agile Process Teams
  • Incidents
  • Incidents - Direct Supplier
  • Incidents - External Manufacturing
Edit Incident - Initial Response Captures when users edit the incident and submit the initial response.
Agile Process Teams
  • Incidents
  • Incidents - Direct Supplier
  • Incidents - External Manufacturing
Edit Incident - Final Response Captures when users edit the incident and submit the final response.
Agile Process Teams
  • Incidents
  • Incidents - Direct Supplier
  • Incidents - External Manufacturing
  • Incidents - Compliance Exception
Close Incident Captures when users close the incident.
Agile Process Teams
  • Incidents
  • Incidents - Direct Supplier
  • Incidents - External Manufacturing
  • Incidents - Compliance Exception
Reopen Incident Captures when users reopen the incident.
Agile Process Teams
  • Incidents
  • Incidents - Direct Supplier
  • Incidents - External Manufacturing

Add Incident From Copy

 Captures when users add a new incident by copying an existing incident.
Agile Process Teams
  • Incidents
  • Incidents - Direct Supplier
  • Incidents - External Manufacturing
  • Incidents - Compliance Exception
Comment or Attachment Added Captures when users add a comment or attachment to the incident.
Agile Process Teams
  • Incidents
  • Incidents - Direct Supplier
  • Incidents - External Manufacturing
  • Incidents - Compliance Exception
Comment or Attachment Edited Captures when users edit a comment or attachment on the incident.
Agile Process Teams
  • Incidents
  • Incidents - Direct Supplier
  • Incidents - External Manufacturing
  • Incidents - Compliance Exception
User Assigned - Responsible Party at [Owner Name] Captures when users set a user as the Responsible Party at [Owner Name].
Agile Process Teams
  • Incidents
  • Incidents - Direct Supplier
  • Incidents - External Manufacturing
  • Incidents - Compliance Exception
User Assigned - Current Assignees at [Owner Name] Captures when users set a user as one of the Current Assignees at [Owner Name].
Agile Process Teams
  • Incidents
  • Incidents - Direct Supplier
  • Incidents - External Manufacturing
  • Incidents - Compliance Exception
User Assigned - Responsible Party at Partner Captures when users set a user as the Responsible Party at Partner.
Agile Process Teams
  • Incidents
  • Incidents - Direct Supplier
  • Incidents - External Manufacturing
  • Incidents - Compliance Exception
User Assigned - Currently Assignees at Partner Captures when users set a user as one of the Current Assignees at Partner.
Agile Process Teams
  • Incidents
  • Incidents - Direct Supplier
  • Incidents - External Manufacturing
  • Incidents - Compliance Exception
Add Link Captures when users add a linked process to the incident.
Agile Process Teams
  • Incidents
  • Incidents - Direct Supplier
  • Incidents - External Manufacturing
  • Incidents - Compliance Exception
Remove Link Captures when users remove a linked process from the incident.
functionalArea businessObjectType action Description
Agile Process Teams Change Requests Add Change Request - Save Captures when users add a new change request.
Agile Process Teams Change Requests Edit Change Request Captures when users edit the change request.
Agile Process Teams Change Requests Close Change Request Captures when users close the change request.
Agile Process Teams Change Requests Reopen Change Request Captures when users reopen the change request.
Agile Process Teams Change Requests Add Change Request - From Copy Captures when users add a new change request by copying an existing change request.
Agile Process Teams Change Requests Comment or Attachment Added Captures when users add a comment or attachment to the change request.
Agile Process Teams Change Requests Comment or Attachment Edited Captures when users edit a comment or attachment on the change request.
Agile Process Teams Change Requests User Assigned - Responsible Party at [Owner Name] Captures when users set a user as the Responsible Party at [Owner Name].
Agile Process Teams Change Requests User Assigned - Current Assignees at [Owner Name] Captures when users set a user as one of the Current Assignees at [Owner Name].
Agile Process Teams Change Requests User Assigned - Responsible Party at Partner Captures when users set a user as the Responsible Party at Partner.
Agile Process Teams Change Requests User Assigned - Currently Assignees at Partner Captures when users set a user as one of the Current Assignees at Partner.
Agile Process Teams Change Requests Add Link Captures when users add a linked process to the change request.
Agile Process Teams Change Requests Remove Link Captures when users remove a linked process from the change request.
functionalArea businessObjectType action Description
Agile Process Teams Change Requests Add Task - Save Captures when users add a new task.
Agile Process Teams Change Requests Edit Task Request Captures when users edit the task.
Agile Process Teams Change Requests Close Task Request Captures when users close the task.
Agile Process Teams Change Requests Reopen Task Request Captures when users reopen the task.
Agile Process Teams Change Requests Add Task - From Copy Captures when users add a new task by copying an existing task.
Agile Process Teams Change Requests Add Sub-task - Save Captures when users add a new sub-task.
Agile Process Teams Change Requests Edit Sub-task Request Captures when users edit the sub-task.
Agile Process Teams Change Requests Close Sub-task Request Captures when users close the sub-task.
Agile Process Teams Change Requests Reopen Sub-task Request Captures when users reopen the sub-task.
Agile Process Teams Change Requests Add Sub-task - From Copy Captures when users add a new sub-task by copying an existing sub-task.
Agile Process Teams Change Requests Comment or Attachment Added Captures when users add a comment or attachment to the task or sub-task.
Agile Process Teams Change Requests Comment or Attachment Edited Captures when users edit a comment or attachment on the task or sub-task.
Agile Process Teams Change Requests User Assigned - Responsible Party at [Owner Name] Captures when users set a user as the Responsible Party at [Owner Name].
Agile Process Teams Change Requests User Assigned - Current Assignees at [Owner Name] Captures when users set a user as one of the Current Assignees at [Owner Name].
Agile Process Teams Change Requests User Assigned - Responsible Party at Partner Captures when users set a user as the Responsible Party at Partner.
Agile Process Teams Change Requests User Assigned - Currently Assignees at Partner Captures when users set a user as one of the Current Assignees at Partner.
Agile Process Teams Change Requests Add Link Captures when users add a linked process to the task or sub-task.
Agile Process Teams Change Requests Remove Link Captures when users remove a linked process from the task or sub-task.
functionalArea businessObjectType action Description
Agile Process Teams

Document Reviews

Add Review - Save Captures when users add a new document review.
Agile Process Teams

Document Reviews

Edit Review - Save Captures when users edit the document review.
Agile Process Teams

Document Reviews

Close Review Captures when users close the document review.
Agile Process Teams

Document Reviews

Reopen Review Captures when users reopen the document review.
Agile Process Teams

Document Reviews

Comment or Attachment Added Captures when users add a comment or attachment to the document review.
Agile Process Teams

Document Reviews

Comment or Attachment Edited Captures when users edit a comment or attachment on the document review.
Agile Process Teams

Document Reviews

User Assigned - Responsible Party at [Owner Name] Captures when users set a user as the Responsible Party at [Owner Name].
Agile Process Teams

Document Reviews

User Assigned - Current Assignees at [Owner Name] Captures when users set a user as one of the Current Assignees at [Owner Name].
Agile Process Teams

Document Reviews

User Assigned - Responsible Party at Partner Captures when users set a user as the Responsible Party at Partner.
Agile Process Teams

Document Reviews

User Assigned - Currently Assignees at Partner Captures when users set a user as one of the Current Assignees at Partner.
Agile Process Teams

Document Reviews

Add Link Captures when users add a linked process to the document review.
Agile Process Teams

Document Reviews

Remove Link Captures when users remove a linked process from the document review.

The Attachment field in Supply Chain Work Management supports the following file types:

  • Document files:
    • .doc, .docx (Microsoft Word)
    • .xls, .xlsx (Microsoft Excel)
    • .ppt, .pptx (Microsoft PowerPoint)
    • .pdf (Adobe PDF)
  • Image files:
    • .jpg
    • .jpeg
    • .png
    • .gif
    • .bmp
  • Audio and video files:
    • .mp3 (audio)
    • .mp4 (video)
    • .avi (video)
    • .mkv (video)
  • Text files:
    • .txt
    • .csv
  • Other files:
    • .json

Uploading any other file type is restricted to prevent malicious files and protect data.

Solutions

TraceLink apps are extended through solutions, which pull together assets that define how the app looks and functions when users interact with it (i.e. the app's data model, pages workflows, roles, and policies). Solutions available in the Marketplace Catalog can be saved as Company Solutions and configured to meet a company's specific use cases and business needs. For more information on solutions and configuring solutions for an app, see the Opus Solution Environment Help Center.

The Supply Chain Work Management solution is available for Agile Process Teams. This solution contains the following processes:

  • Incidents
  • Incidents - Direct Supplier
  • Incidents - External Manufacturing
  • Incidents - Compliance Exception
  • Change Requests
  • Tasks
  • Document Reviews
  • Add networks to link internal and external stakeholders and multi-disciplinary teams with core business stakeholders and domain experts.
  • Assign roles to internal and external team members.
  • Add new process items.
  • Assign team members to those items.
  • Share documents associated with the item.
  • Communicate with team members in the context of the item.
  • Leverage operational dashboards to monitor progress in real time against due dates, priorities, and trade partners.
  • Filter items by key data fields.
  • Download CSV files with data for process items.
  • Quickly view and edit items inline.
  • View and edit full details of items.
  • Link an item to related items in the network (e.g. link a change request to the incident that prompted the process change).
  • View the multi-disciplinary team members that are following an item.
  • View an activity history for item analysis and process improvement (i.e. to understand who took actions when).
  • Reopen closed items.
  • Copy items to quickly begin working on a new item similar to one that already exists.

Roles

  • 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.

Roles group a set of permissions for specific actions (either in the UI or via API), side menu items, and data within an app. The solution applied to the app or its network determines which roles are available. Administrators assign users to roles when they assign users to an app, its network, or its Links.

Owners assign specific roles to Links, allowing their Partners to assign those roles to the Partner users with access to the Link.

Companies must own Opus Solution Environment (OSE) to add or edit roles. If your company owns OSE and you also have the Company Solution Developer role assigned, you can add new roles to a Company Solution or edit existing roles by navigating to OSE and selecting Roles in the side menu. See the Opus Solution Environment Help CenterOpus Solution Environment Help Center for more information. If your company does not own OSE, then contact TraceLink Support for more information.

Opus Platform

Passwords must be a minimum of 8 characters, must not be your email, and must include at least one:

  • Numerical digit
  • Lowercase letter
  • Uppercase letter
  • Special character

If your company was enabled on the Opus Platform from Track & Trace Services, the following password settings from Track & Trace Services apply:

  • Number of previous passwords that cannot be reused.
  • Number of login attempts allowed before the account is locked.
  • Number of days until the password expires.

If your company was not originally enabled on Track & Trace Services, the following default settings apply to TraceLink SSO:

  • The previous 6 passwords cannot be reused.
  • 5 login attempts are allowed before the account is locked.
  • Passwords expire in 30 days.

The Opus Platform supports the following web browsers:

  • Google Chrome: Versions 57, 68, 74, or above
  • Microsoft Edge: Version 80 or above
  • Microsoft Edge (Legacy): Versions 16, 17, and 18
  • Mozilla Firefox: Versions 60, 63, 67, or above
  • Apple Safari: Versions 12.1.2, 13.0, or above

The Opus Platform supports the following mobile browsers:

  • Google Chrome Mobile: Version 80.0 or above
  • Android Web View: Version 80.0 or above
  • iOS Safari: Version 13.1 or above