FDA: Change Control Audit Checklist Mobile App
The FDA Change Control Audit mobile app covers the basic elements that must be completed as part of a change control program.
- Submission Editing
- Reference Data
Easily accessible from any smartphone or tablet, the app generates a checklist of guidelines to follow and creates electronic records of the completed items to ensure FDA compliance. Designed for medical device manufacturers and other types of items that require FDA inspections, the FDA Change Control app makes it easy to develop a change management control plan that meets the regulatory requirements of FDA inspectors and internal auditors.
While having a change control plan in place isn't necessarily required during the initial research and development phases of a new medical device or product, it is required (as part of FDA regulations) before the equipment is deemed ""ready for production"". Having a change management plan in place early in the process helps ensure FDA regulatory compliance. The app covers the most important aspects of developing quality systems and change control for clinical trials, risk management and design control.