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, Approved, In Implementation, Verification, Rejected, Closed). Under Review and Implemented are also listed; they are legacy values that no change request reaches today.
   • 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).

Column headers with an arrow are sortable – select one to sort by that column, and again to reverse the direction. Your sort choice is carried in the page address, so it survives a refresh or a link shared with a colleague.

Save a filtered view

If you find yourself setting the same search text and filters every time you open the register, save them as a named view instead of rebuilding them.

1. On the left sidebar, select Change Control.
2. Set the search text and filters you want to save.
3. Select Views in the toolbar, then select Save current view….
4. Enter a name and select Save.

To reapply a saved view, select Views and choose it from the list – the search text and every filter it was saved with are restored together. To remove one you no longer need, select the trash icon next to it in the list.

Note

Saved views are personal: only you see the views you save, on any device you sign in from. There is currently no way to share a view with the rest of your team.

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 (with an electronic signature) and is ready to implement
In implementation	The change is being implemented; its tasks and implementation evidence are recorded
Verification	Implementation is complete and the change is waiting to be verified, then closed
Rejected	The change request was not approved (terminal state)
Closed	The change was implemented, verified effective and closed with an electronic signature (terminal state)

Note

The workflow is Draft → Submitted → Approved → In implementation → Verification → Closed, or Rejected from Submitted. A verification that finds the change not effective sends it back to In implementation. Rejected and Closed are terminal. See Implementation, verification and closure.

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

The register and a change request’s own page always agree: if a change request is not listed for you, opening its link shows an access error instead of the record, its tasks, approvals, attachments or history (an auditor account sees a “not found” page instead). Viewing every change request comes with the authority to act on any of them (administer, assess, approve, implement or verify), which Admin and QA_Team hold by default; read access on its own covers your own change requests. An administrator can also share a specific change request with a named auditor, read-only – see Share a change control with an auditor.

Action	Allowed Roles
View change requests	Admin and QA_Team see every change request. Everyone else sees the ones they raised, are assigned, or are named on as assessor, approver or implementation-task owner. Auditors also see the ones shared with them, read-only
Share a change request with an auditor, or withdraw it	Admin
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
Start and complete implementation	Requester, assigned user, Admin, QA_Team
Verify the change (signed)	Admin, QA_Team – not the person who completed the implementation
Close the change (signed)	Admin, QA_Team

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 engineer assigned to CC-047 starts implementation, records the firmware update as an implementation task, attaches the installation record as implementation evidence, and sends the change for verification – see Implementation, verification and closure.
8. A QA verifier reviews tablet hardness over three batches, attaches the results as verification evidence, and signs the verification as Effective.
9. A QA approver closes CC-047 with an electronic signature. The change request is now Closed – the end of its lifecycle.