Change Requests

Overview

A Change Request (CR) is the controlled way to propose, approve, and carry out a change to your quality system — a procedure update, a process modification, an equipment swap, a supplier change, and so on. Instead of making changes ad hoc, you raise a CR, route it through an approval workflow, implement it as a set of tracked sub-tasks, and (optionally) verify that the change worked.

You'll find Change Requests under Quality Management. The landing page shows summary tiles (Open CRs, Awaiting approval, Urgent open, Closed this month), a filterable list, and a New Change Request button. A CR can also be raised directly from a Nonconformance or a CAPA, in which case its title, site, and department are pre-filled from the originating record.

Key concepts

Statuses

A CR moves through a lifecycle from draft to closure. The status appears in the Overview panel of each CR and as a filter on the list.

Status	What it means
Draft	Being prepared by the owner. Editable and can be deleted.
Under Review	Submitted; the approval workflow is running and reviewers are acting on it.
Approved	Approvals are complete; implementation can begin.
In Implementation	Implementation sub-tasks are being worked.
Pending Effectiveness	Implementation done; awaiting the effectiveness check.
On Hold	Temporarily paused.
Rejected	An approver declined the change.
Cancelled	Abandoned after submission, with a recorded reason.
Closed	Completed successfully and signed off.

Change types and classification

Field	Purpose
Change Type	Category of the change (configured by your admin). Some types may flag that a risk assessment or root-cause analysis is expected.
Classification	Impact level: Minor, Major, or Critical. Optional, but useful for prioritising.
Priority	How urgent the change is (e.g. Low, Medium, High, Urgent — configured by your admin).

note

Change types, priorities, and statuses are configured for your company, so the exact names you see may differ from the examples above.

How to raise a Change Request

1. Open Change Requests and click New Change Request.
2. Enter a Title and, optionally, a Description explaining what is changing and why.
3. Choose the Change Type (required) and, if relevant, a Classification.
4. Set the Priority (required).
5. Select the approval Workflow (required). Only active Change Control workflows appear here.
6. Pick the Site, Department, and Owner (all required). Changing the site resets the department.
7. Set the Initiated date (required), and optionally a Target Implementation Date and Due Date.
8. Fill in Reason for Change and Business Justification if you have them.
9. Turn on Requires effectiveness check if you want post-implementation verification tracked (recommended for Major or Critical changes).
10. Click Create Draft.

The CR opens as a Draft. While it is a draft, you (the owner) can click any field on the detail page to edit it; changes save automatically.

How to submit for approval

1. Open the draft CR.
2. In the Approval Workflow Plan section, assign a reviewer to each approval step. The reviewer picker only offers people in the role required for that step.
3. Click Submit for Approval in the page header and confirm in the dialog.

The status changes to Under Review, each reviewer receives a task in their inbox, and the CR becomes a permanent audit record.

warning

Once submitted, a CR can no longer be deleted — it can only be closed or cancelled with a recorded reason. Delete a CR while it is still a draft if you don't intend to proceed.

How reviewers approve a CR

Each approval step appears as a workflow step on the CR. The assigned reviewer can Mark Complete to approve and advance, and (where configured) may need to add an e-signature. Owners can Reassign, Cancel, or send a step back. When all approval steps are complete, the CR becomes Approved and implementation begins.

How to implement an approved change

Once approved, the Implementation stage lets the owner break the change into sub-tasks — one per affected area.

1. Open the CR and find the Implementation stage in the workflow section.
2. Click Add Sub-task.
3. Enter a Sub-task name (e.g. "Update SOP-001", "Assign training", "Notify supplier").
4. Add Instructions, an optional SLA (due in days), and choose an Assignee.
5. Optionally attach a Form (build one, or start from a template) and toggle Require Comments or Require E-signature.
6. Click Add Sub-task.

Each assignee sees their sub-task, fills in any form, and clicks Mark Complete. Owners can reassign or cancel a sub-task while it is still active. Use sub-tasks to cover every item the change affects — document updates, training, supplier notifications, validation, and so on.

How to close or cancel a CR

• Close marks the change complete. It's available once the CR is Approved, In Implementation, Pending Effectiveness, or On Hold. Add optional closure notes and sign to confirm.
• Cancel abandons a CR after it was submitted. A reason is required and you'll sign to confirm. The record stays in the audit log and cannot be re-opened.

tip

Use Print to generate a printable record and Audit Log to see the full history of the CR and its workflow steps — useful for inspections and audits.