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 Setting.
Expand the setting by clicking the arrow down icon.
Complete the fields in General Information, Planning, and Execution (see below).
Click Save.
📎 Reference: Understanding the Change Request workflow
Step 2: Fill in General Information
Define the base configuration for this Change Request type.
Field name | Description | Note |
Type of Change* | The name/type of the Change Request being created. | Use a clear, actionable name (e.g., “SOP Revision”, “Equipment Qualification”). |
Description | Short explanation of the scope and intent of this CR type. | Helps users select the correct CR type. |
Base Template | Select an existing template or upload a document used as the base for new CRs. | If left blank, a file can be uploaded when creating the CR. |
❗ Compliance: Ensure the Base Template is version-controlled and approved according to your document control procedure.
Step 3: Configure Planning Phase
Set review and approval requirements before execution.
Field name | Description | Note |
Include Review Phase | Toggle ON to include a review step in planning. | For technical/QA peer review of change scope. |
Include Approval Phase | Toggle ON to include an approval step in planning. | For QA/management approval prior to execution. |
Include Controlled Items | Toggle ON to include controlled items in scope. | Leave OFF if no controlled items are required. |
💡 If your CR impacts regulated documents or systems, keep Review and Approval ON to document decision-making before any work begins.
Step 4: Configure Execution
Define checks required after implementation.
Field name | Description | Note |
Include Review Phase | Toggle ON to include a review step during execution. | Confirms execution completeness and evidence. |
Include Approval Phase | Toggle ON to include an approval step during execution. | Final QA/management sign-off post-execution. |
Step 5: Remove a Change Control Setting
Delete configurations that are no longer applicable.
Go to Settings > Change Control.
Select and expand the setting (arrow down).
Review details to confirm removal.
Click Remove.
Click Apply Setting to ensure the removal is applied across the system.
❗ 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.