Skip to content

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.

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

Each change request progresses through the following statuses:

StatusDescription
DraftInitial state when a change request is created but not yet submitted
SubmittedThe change request has been formally submitted for review
Under ReviewThe request is being evaluated through impact assessment
ApprovedThe change has been approved for implementation
RejectedThe change request was not approved
ImplementedThe approved change has been put into effect
ClosedThe change has been verified and the record is closed
TypeDescription
DocumentChanges to controlled documents, SOPs, or work instructions
ProcessChanges to manufacturing or quality processes
EquipmentChanges to equipment, instruments, or tooling
SystemChanges to computer systems or software
SupplierChanges to supplier qualifications or materials

The change control list displays the following columns:

ColumnDescription
Change #Unique identifier assigned automatically to each request
TitleBrief description of the change
TypeCategory of change (Document, Process, Equipment, System, Supplier)
PriorityUrgency level (Critical, High, Medium, Low)
StatusCurrent lifecycle status
StepCurrent workflow step
RequesterUser who submitted the request
AssigneeUser responsible for the change (if assigned)
CreatedDate the request was created
ActionsView and edit buttons
ActionAllowed Roles
View change requestsAll authenticated users
Create new change requestAll authenticated users
Edit change requestOriginal requester, Admin
Perform impact assessmentAuthorized assessors
Approve/reject changeDepartment Managers, QA, Regulatory, Executive