FDA: Change Control Audit Checklist
This change control checklist generates a list of guidelines to follow during a change control audit and creates electronic records of the completed items to ensure FDA compliance.
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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. The app easily outlines the quality processes involved in the inspection, making it easy to adhere to your change management strategy.
While having a change control plan and processes 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 to be ready for production. Having a change management plan in place early in the process helps ensure FDA regulatory compliance by providing a list of implemented practices and operations details typically found in a change control plan.
The app covers the most important aspects of developing quality systems and change control for clinical trials, risk management and design control, and provides the tools you need to manage the process from any mobile device.