CHANGE CONTROL KEY TO REMAINING COMPLIANT, EXPERT SAYS
To stay compliant with FDA regulations, devicemakers need to have reliable processes for implementing certain changes, an industry consultant says.
In a process known as "change control," firms identify a needed change, justify it, document it, get it approved, communicate with and train personnel on the change control process, and implement and evaluate that process, Barbara Immel, president of Immel Resources, told attendees at an FDAnews audioconference last month.
Change control can track design changes, document changes, changes in a product or service from suppliers, contractors and consultants, or production and process changes.
Firms need to study whether a proposed change could have a negative or unintended effect on product quality or effectiveness, and any parties potentially affected by the change(s) need to be notified, Immel said.