Who Is This For?
System Administrators – configuring global CR behavior
QA Administrators – enforcing review/approval and effectiveness checks for GxP changes
Process Owners – aligning CR phases with SOPs and quality procedures
How to Do It?
Step 1: Create a Change Control Setting
Configure a new setting to define the framework for managing Change Requests.
Go to Settings > Change Control.
Click Add change type.
Expand the setting by clicking the arrow down icon.
Modify the fields based on the table below and Save.
Part 1: General Information
Field name | Description | Note |
Name* | Defines the name or type of the Change Request being created. |
|
Base Template | Select an existing template or upload a document to be used as the base for new Change Requests. | If left blank, you may upload a file when creating the CR. |
Description | Provide a clear description for this Change Request type. |
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❗ Compliance: Ensure the Base Template is version-controlled and approved according to your document control procedure.
Part 2: Planning and Execution Phase
Field name | Description | Note |
Review Plan | Toggle ON to include a review stage in the planning phase. |
|
Approve Plan | Toggle ON to include an approval stage in the planning phase. |
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Review Change Request | Toggle ON to include a review stage in the execution phase. |
|
Approve Change Request | Toggle ON to include an approval stage in the execution phase. |
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💡 If your CR impacts regulated documents or systems, keep Review and Approval ON to document decision-making before any work begins.
Part 3: Controlled Items and Assess Effectiveness
Field name | Description | Note |
Control Items | Toggle ON to include controlled items in the CR scope. | Leave OFF if no controlled items are required. |
Assess Effectiveness | Toggle ON to assess effectiveness, once controlled items have been released |
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📎 Reference: Understanding the Change Request workflow
Step 2: Update a Change Control Setting
Updating an existing Change Control Setting allows adjustments to its details, phases, or evaluation requirements without creating a new configuration.
Go to Settings > Change Control.
Select and expand the setting by clicking the arrow down icon.
Update the fields as required.
d. Click Save.
Step 3: Delete a Change Control Setting
Delete configurations that are no longer applicable permanently deletes the configuration and its association with new Change Requests.
Go to Settings > Change Control.
Locate and Select the relevant settings and expand the setting (click arrow down).
Review details to confirm removal.
Click the trash bin icon to delete the setting.
❗ Warning: Removing a setting will prevent its use for new CRs. Historical records remain unchanged. Validate that no active or draft CRs depend on this setting before removal.
Tips
💡 Align Type of Change names with controlled terminology in your SOPs to avoid confusion.
💡 Use Planning Review + Approval for all GxP-impacting changes; pair with Effectiveness Check when risk is medium/high.
💡 If CRs relate to specific documents or systems, enable Controlled Items to keep scope explicit and auditable.