Change Control
Walk through MoniDoseQMS's change control module — create change requests, set priority and type, link to any QMS module, run impact assessments, attach documents, and manage the full review and approval workflow.
Change control keeps every modification to your product, process, or documentation tracked, assessed, and approved. Here's how MoniDoseQMS makes it simple.
What you'll learn
- 1
Dashboard overview
See total change controls, open items, pending approvals, and critical items at a glance. Filter and search by status, type, or priority.
- 2
Create a change request
Auto-generated or custom ID, title, change type (corrective, preventive, design, manufacturing, documentation, regulatory, supplier), and priority level (low, medium, high, critical).
- 3
Link to any QMS module
Associate the change with Core QMS, products, processes, assets, CAPA, materials, suppliers, regulatory submissions, adverse events, design projects, management review, training, and more — keeps traceability built in.
- 4
Impact assessment
Define the safety, regulatory, and risk impact. Flag whether notified body or regulatory authority notification is required. Specify verification and validation requirements.
- 5
Attach documents
Upload files from your computer or select from the document library. Add multiple files per change request — no limit.
- 6
Review and approval workflow
Assign a primary and secondary reviewer. Add comments, tag team members, and create tasks. The full workflow is tracked in the audit trail.
- 7
View, edit, and track
View full details with traceability references, edit the request while it's in draft, and follow it through to approval — all from the action icons.