The Change Control module provides a structured process for managing changes to documents, processes, equipment, systems, and suppliers within your quality management system. Every change request follows a defined lifecycle from initial submission through impact assessment, approval, implementation, and closure.
- On the left sidebar, select Change Control.
- Select New Change Request.
- Fill in the required fields for the change request (title, description, type, and priority).
- Submit the form to create the change request.
- On the left sidebar, select Change Control.
- To search by title, change number, or description, enter text in the Search changes field.
- To narrow results, use any combination of these filter dropdowns:
- All Statuses — filter by lifecycle status (Draft, Submitted, Under Review, Approved, Rejected, Implemented, Closed).
- All Priorities — filter by priority level (Critical, High, Medium, Low).
- All Types — filter by change type (Document, Process, Equipment, System, Supplier).
- To view a change request, select the eye icon button in the Actions column.
- To edit a change request, select the pencil icon button in the Actions column (available to the original requester and administrators).
- On the left sidebar, select Change Control.
- Locate the change request in the table.
- Select the eye icon button in the Actions column to open the change request detail page.
- On the left sidebar, select Change Control.
- Locate the change request in the table.
- Select the pencil icon button in the Actions column.
- Modify the change request details as needed.
- Save your changes.
Each change request progresses through the following statuses:
| Status | Description |
|---|
| Draft | Initial state when a change request is created but not yet submitted |
| Submitted | The change request has been formally submitted for review |
| Under Review | The request is being evaluated through impact assessment |
| Approved | The change has been approved for implementation |
| Rejected | The change request was not approved |
| Implemented | The approved change has been put into effect |
| Closed | The change has been verified and the record is closed |
| Type | Description |
|---|
| Document | Changes to controlled documents, SOPs, or work instructions |
| Process | Changes to manufacturing or quality processes |
| Equipment | Changes to equipment, instruments, or tooling |
| System | Changes to computer systems or software |
| Supplier | Changes to supplier qualifications or materials |
The change control list displays the following columns:
| Column | Description |
|---|
| Change # | Unique identifier assigned automatically to each request |
| Title | Brief description of the change |
| Type | Category of change (Document, Process, Equipment, System, Supplier) |
| Priority | Urgency level (Critical, High, Medium, Low) |
| Status | Current lifecycle status |
| Step | Current workflow step |
| Requester | User who submitted the request |
| Assignee | User responsible for the change (if assigned) |
| Created | Date the request was created |
| Actions | View and edit buttons |
| Action | Allowed Roles |
|---|
| View change requests | All authenticated users |
| Create new change request | All authenticated users |
| Edit change request | Original requester, Admin |
| Perform impact assessment | Authorized assessors |
| Approve/reject change | Department Managers, QA, Regulatory, Executive |