Using Change Action Paths & Steps

Change Action Paths allow your organization’s Admin to configure a Change Control, Quality Event (Change Control object type only), or Change Plan to organize Change Actions in sequential steps based on phases of the Change Control. When configured, Vault QMS will automatically start Change Actions in the order based on the sequencing in the Change Actions Steps.

Creating Change Action Paths & Steps

Before creating a Change Action Path, an Event Action must be added to the Parent Lifecycle.

To create an Event Action for your Parent Lifecycle:

Navigate to Admin > Configuration > Object Lifecycles > [Lifecycle] > Event Actions.

To create a Change Action Path:

1. From the QMS Action Path Configurations page, click Create.
2. Enter a Label and Name for the Change Action Path.
3. Use the Status selector to make the field active or inactive.
4. Optional: Enter a Description
5. Select the Parent Object in the drop-down.
6. Select the Parent Object Type in the drop-down.
7. Select the Action Object.
8. Select one or more Parent Locked States.
9. Click Save.

To create Change Action Steps within a Change Action Path:

1. From the QMS Action Path Configuration page, select a change action path. Under QMS Action Step Configurations, click Edit.
2. Enter a Label.
3. Select the Parent Start State from the drop-down. When parent objects reach this state, actions in the included action state(s) will be moved to the action start state.
4. Select the Action Start State from the drop-down.
5. Select the Included Action States. Actions must be in the included action state(s) to be moved to the action start state when the parent reaches the parent object start state.
6. Select the Action Finished States. This is the terminal state for actions in the step.
7. Select the Parent Finish State. This is the destination state for parent objects when all actions have moved to one of the action finish states.
8. Optional: Move the Display Order.
9. Click Save.

Action Path Example: GMP Change Control

Suppose your organization creates a GMP Change Control to reset the steady state temperature of a freezer from -80ºC to -70ºC in a microbiology lab.

Some Change Actions need to be executed before others. The Change Control owner defines the appropriate sequencing of Change Actions. When all Change Actions are Completed, the GMP Change Control moves to the In Final Approval state.

Your Vault Admin has configured a Change Action Path for GMP Change Controls that includes a pre-implementation step, followed by an implementation step, and finally a post-implementation step. During the change definition stage of the Change Control process, the Change Control’s owner adds Change Actions to these steps.

The Admin has defined the Change Action Path as follows:

• Pre-Implementation Step
  • Change Action: Update any SOPs that mention -80ºC
  • Change Action: Update the logbook used to quality check the freezer’s temperature each day.
• Implementation Step
  • Change the temperature of the freezer to -70ºC
• Post-Implementation Step
  • Perform stability tests on samples after one (1) week at -70ºC

When the GMP Change Control enters the In Pre-Implementation state, Vault QMS starts the Change Actions in the Pre-Implementation Step by automatically moving them to the Start Implementation state.

When the Change Actions in the Pre-Implementation Step are finished and moved to the Closed state, Vault QMS automatically moves the parent Change Control to the In Implementation state, and this automatically moves the Change Action in the Implementation Step to the Start Implementation state.

When the Change Action in the Post-Implementation Step is finished and moves to the Closed state, Vault QMS automatically moves the parent Change Control to the In Final Approval state and starts the final approval workflow. Users can create and remove child records from one step to another as long as both steps are open. Users can’t add or remove child records from Steps in the Implementation and Post Implementation states.