Change Control

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.

Create a change request

1. On the left sidebar, select Change Control.
2. Select Raise change.
3. Fill in the required fields for the change request (title, description, type, and priority).
4. Submit the form to create the change request.

Tip

Use the search bar to quickly locate a change request by its change number (for example, “CC-001”) or by keywords in the title or description.

Filter and find change requests

1. On the left sidebar, select Change Control.
2. To search by title, change number, or description, enter text in the Search changes field.
3. 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).
4. To view a change request, select the eye icon button in the Actions column.
5. To edit a change request, select the pencil icon button in the Actions column (available to the original requester and administrators).

View a change request

1. On the left sidebar, select Change Control.
2. Locate the change request in the table.
3. Select the eye icon button in the Actions column to open the change request detail page.

Edit a change request

1. On the left sidebar, select Change Control.
2. Locate the change request in the table.
3. Select the pencil icon button in the Actions column.
4. Modify the change request details as needed.
5. Save your changes.

Note

Only the original requester and users with the Admin role can edit a change request.

Change control lifecycle

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
Approved	The change has been approved for implementation (terminal state)
Rejected	The change request was not approved (terminal state)
Under Review	Reserved — defined in the data model but not yet reachable
Implemented	Reserved — defined in the data model but not yet reachable
Closed	Reserved — defined in the data model but not yet reachable

Note

The active workflow today is Draft → Submitted → Approved or Rejected. Approved and Rejected are terminal. Under Review, Implemented, and Closed are defined in the data model for future use but are not yet reachable — a change request cannot currently enter those states.

Change types

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

Table columns

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

Permissions

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

Practical example: Equipment modification change request

A pharmaceutical company discovers that a tablet press (EQ-042) needs a firmware update to address a calibration drift issue affecting batch uniformity.

1. The production supervisor navigates to Change Control and selects Raise change.
2. They fill in the form:
   • Title: “Tablet Press EQ-042 Firmware Update v3.2.1”
   • Change Type: Equipment
   • Priority: High
   • Description: “Firmware update required on Korsch XL 400 tablet press to resolve calibration drift observed during recent batch records BR-2026-0114 through BR-2026-0118. Current firmware v3.1.0 has a known defect in pressure sensor auto-calibration.”
   • Reason for Change: “Calibration drift is causing tablet hardness variability outside specification limits (USP <1217>). Vendor released firmware v3.2.1 specifically addressing this defect.”
3. The request is created as CC-047 with status Draft.
4. The supervisor submits it, moving the status to Submitted.
5. An authorized assessor performs a Technical assessment evaluating the firmware compatibility.
6. The Department Manager and QA review and approve the change.
7. The maintenance team implements the firmware update and verifies tablet hardness is within specification.
8. The change request is now in the Approved state, which is terminal in the current workflow. Implementation and verification are tracked operationally; dedicated Implemented and Closed states are defined in the data model but are not yet active.