Module spotlight: Change Control

Uncontrolled change is one of the fastest ways to introduce risk into a regulated product. Change Control turns every modification — to a design, a process, a supplier, or a document — into a formal, assessed, and approved event with a clear record behind it.

What you can do

• Raise change requests with type and priority (corrective, design, manufacturing, regulatory, supplier, and more)
• Run an impact assessment across safety, regulatory, and risk
• Flag whether notified-body or authority notification is required
• Define verification and validation requirements
• Route through a tracked review-and-approval workflow, linked to the records it affects

Why it matters

Because change control is connected to the modules a change touches, the ripple of a change is visible rather than hidden. That traceability is exactly what auditors look for — and what keeps a small change from becoming a large surprise.