top of page
Icologiq Knowledge ยท Process
Change Control
A formal process for proposing, assessing, approving, implementing and documenting changes that can affect quality, compliance, products or validated processes.
Also known as:
quality change control, controlled change
At a glance
Definition
Change control provides a defined workflow for evaluating proposed changes before they are implemented. It typically includes impact assessment, responsibilities, approvals, implementation activities, required updates and closure evidence. In regulated environments it helps prevent unintended consequences.
Why it matters
Change Control is especially important in MedTech and regulated quality environments, where changes can affect documentation, training, risk, validation, suppliers and regulatory commitments.
ARC-006
A formal process for proposing, assessing, approving, implementing and documenting changes that can affect quality, compliance, products or validated processes.
Change control provides a defined workflow for evaluating proposed changes before they are implemented. It typically includes impact assessment, responsibilities, approvals, implementation activities, required updates and closure evidence. In regulated environments it helps prevent unintended consequences.
bottom of page