Overview #
The Workflow Manager in DnXT Administrator provides a visual, drag-and-drop workflow designer for creating multi-step approval and review processes. Built on the Cytoscape.js graph library, it enables administrators to design workflows as state-machine diagrams — defining states (stages), transitions (movements between stages), rules (conditions and side-effects), and triggers (automated actions like sending emails).
Workflows created here are used across DnXT Publisher and DnXT Reviewer to automate submission lifecycle processes such as document review cycles, submission approval chains, and publishing sign-off procedures.
Accessing Workflow Manager #
- Log in to DnXT Administrator.
- Click Workflow Manager in the left sidebar.
- The Workflow Manager view opens with a workflow list on the left and the visual designer canvas on the right.
Workflow List (Left Sidebar) #
The left sidebar displays all defined workflows organized by module. Each workflow entry shows:
- Workflow Name — The display name of the workflow
- Module — Which DnXT module the workflow belongs to (Publisher, Reviewer)
- Status Badge — Either Published (green badge, active and in use) or Draft (grey badge, under development)
Click a workflow name to load it in the visual designer canvas.
Visual Designer Canvas #
The center of the screen is the workflow designer canvas — a zoomable, pannable workspace where you create and arrange workflow elements. The canvas displays state nodes (circles or rounded rectangles) connected by transition edges (arrows).
Canvas Toolbar #
The toolbar above the canvas provides the following controls:
| Button | Action |
|---|---|
| Add Start | Add a Start state node to the canvas (every workflow needs exactly one) |
| Add State | Add a new State node (an intermediate stage in the workflow) |
| Add End | Add an End state node (the terminal state of the workflow) |
| Transition Mode | Toggle draw mode to create transitions by clicking a source state then a target state |
| Zoom In / Zoom Out | Adjust the canvas zoom level |
| Auto Layout | Automatically arrange all nodes in a clean, readable layout |
Working with the Canvas #
- Pan — Click and drag on empty canvas space to move the viewport
- Zoom — Use the mouse scroll wheel or the zoom controls in the toolbar
- Move Nodes — Click and drag any state node to reposition it on the canvas
- Select — Click a node or edge to select it and view its properties in the right panel
Creating a Workflow #
Follow these steps to create a new workflow from scratch:
Step 1: Create the Workflow #
- Click the Add button (or right-click in the workflow list and select New Workflow).
- Enter a Workflow Name (e.g., “Submission Approval Workflow”).
- Select the Module this workflow applies to (Publisher or Reviewer).
- Click Save. The new workflow appears in the list with a Draft badge.
Step 2: Add States #
- Click Add Start in the toolbar. A green Start node appears on the canvas.
- Click Add State to add intermediate states. Common examples:
- “In Review” — Document is being reviewed
- “Approved” — Document has been approved
- “Rejected” — Document was rejected and needs revision
- “Ready for Publishing” — Submission is approved and ready to be published
- Click Add End to add a terminal state (e.g., “Published”, “Completed”).
- Drag nodes to arrange them in a logical flow on the canvas.
Step 3: Create Transitions #
- Click the Transition Mode button in the toolbar to enter draw mode.
- Click the source state (where the transition starts).
- Click the target state (where the transition goes).
- An arrow (edge) is drawn connecting the two states.
- Repeat for all desired transitions.
- Click Transition Mode again to exit draw mode.
Step 4: Configure State Properties #
Click any state node to select it and open the Properties Panel on the right side. State properties include:
- Name — The display name of the state
- Type — Start, State, or End
- Delete — Remove the state from the workflow
Step 5: Configure Transition Properties #
Click any transition edge (arrow) to select it and open its properties. Transition properties include:
- Name — A label for the transition (e.g., “Approve”, “Reject”, “Submit for Review”)
- From — The source state (read-only, set by the edge connection)
- To — The target state (read-only, set by the edge connection)
- Rules — Conditions and side-effects attached to this transition
- Triggers — Automated actions fired when this transition occurs
- Delete — Remove the transition
Rules #
Rules define conditions that must be met or side-effects that occur when a transition is executed. DnXT supports the following rule types:
| Rule | Description | Use Case |
|---|---|---|
| Lock Entity | Prevents further edits to the entity (dossier, submission, or document) after this transition | Lock a submission after it is approved to prevent unauthorized changes |
| Restrict Status Change | Limits which users or roles can execute this transition | Only managers can move a document from “In Review” to “Approved” |
| Sync To Reviewer | Automatically synchronizes the entity to DnXT Reviewer when this transition fires | Auto-sync a submission to Reviewer when it enters “Ready for Review” |
| Publish Submission | Triggers the eCTD publishing process for the submission | Automatically publish a submission when it reaches the “Publish” state |
Adding a Rule to a Transition #
- Select a transition edge on the canvas.
- In the Properties Panel, locate the Rules section.
- Click Add Rule.
- Select the rule type from the dropdown.
- Configure the rule parameters (varies by rule type).
- Click Save.
Triggers #
Triggers are automated actions that fire when a transition is executed. They enable notification workflows and approval chains.
Send Email #
The Send Email trigger sends a notification email when the transition occurs. Configure:
- Email Template — Select from the templates defined in Configurations > Mail Templates
- Recipients — Define who receives the email (specific users, roles, or the entity owner)
Send Email with Actions #
The Send Email with Actions trigger sends an email that includes interactive action buttons. This is the cornerstone of approval workflows — recipients can approve, reject, or take other actions directly from the email without logging into DnXT.
Configurable Parameters #
| Parameter | Description |
|---|---|
| Email Template | The email template to use for the notification |
| Action Buttons | The clickable buttons included in the email. Available actions: Approve, Reject, Complete, Review, Request Changes |
| Send To | Recipients of the email (specific users, roles, groups, or dynamic fields) |
| Link Expiry | How long the action links in the email remain valid (e.g., 24 hours, 7 days) |
| 21 CFR Part 11 Re-Auth | When enabled, recipients must re-authenticate (enter their password) before the action is executed, ensuring compliance with 21 CFR Part 11 electronic signature requirements |
Adding a Trigger to a Transition #
- Select a transition edge on the canvas.
- In the Properties Panel, locate the Triggers section.
- Click Add Trigger.
- Select the trigger type (Send Email or Send Email with Actions).
- Configure the trigger parameters.
- Click Save.
Publishing a Workflow #
Workflows must be published before they take effect in the system.
- Complete your workflow design with all states, transitions, rules, and triggers.
- Verify the workflow structure — ensure there is exactly one Start state, at least one End state, and all states are reachable via transitions.
- Click Publish (or change the workflow status from Draft to Published).
- The workflow status badge changes to Published and the workflow becomes active.
Example: Submission Approval Workflow #
Here is a typical workflow for submission approval:
- Start → “Draft” (initial state for new submissions)
- “Draft” → “In Review” (transition: “Submit for Review”, trigger: Send Email to reviewers)
- “In Review” → “Approved” (transition: “Approve”, trigger: Send Email with Actions to the author, rule: Lock Entity)
- “In Review” → “Changes Requested” (transition: “Request Changes”, trigger: Send Email to the author with details)
- “Changes Requested” → “In Review” (transition: “Resubmit”, trigger: Send Email to reviewers)
- “Approved” → End (transition: “Publish”, rule: Publish Submission)
FAQ #
Can I edit a published workflow? #
Yes, but exercise caution. Changes to a published workflow take effect immediately. Entities currently in the middle of the workflow will follow the updated path. If you need to make significant structural changes, consider creating a new workflow version and deprecating the old one.
What happens to entities in progress when I change a workflow? #
Entities remain in their current state. If you remove a state that has entities in it, those entities will be “orphaned” — they cannot transition forward until the state is restored or the entities are manually reassigned.
Can I have multiple workflows for the same module? #
Yes. You can create multiple workflows for a single module and assign them to different entity types or use cases. For example, you might have one workflow for initial submissions and another for supplements/amendments.
Are workflow action emails tracked in the Audit Trail? #
Yes. All workflow transitions, email sends, and action responses (approve, reject, etc.) are recorded in the Audit Trail with full details including the user who took the action and the timestamp.