Change control in Swat iQua Suite shares the deviation lifecycle — the same review, approval and decision steps and the same four-person separation — and adds an effectiveness review after closure. QA teams learn one way of working, and inspectors see the same controls applied to planned and unplanned events.
Change actions are the corrective mechanism
Once a change is approved and the decision-taker chooses to proceed, the work is carried out as change actions. Each action has an owner and a due date and is verified by someone else. Requests for more time are logged as extensions that can only move a date forward, and the system refuses to verify an overdue action that has no approved extension.
Change control does not raise CAPAs. Its corrective mechanism is its own set of verified change actions, which keeps the change record complete in one place rather than split across registers.
Effectiveness review
After closure a change can sit in Closed – Effectiveness Pending until a reviewer confirms the change achieved what it set out to do. The reviewer must not be the person who initiated the change, and the review is blocked while the change is only interim-closed, so effectiveness is judged on a finished change.
Assessing the risk of a change
Where a change needs a structured risk assessment, QA can open an FMEA register in Quality Risk Management scoped to that change. When a change touches an SOP, the revised SOP goes through its own review, approval and make-effective steps in SOP & Document Control, and training follows from the new version.