Look through even a few FDA warning letters and you’re likely to find violations related to change management.

For instance, a recent warning letter from the U.S. Food and Drug Administration cited a pharmaceutical manager for changing drug components without justification. Another noted a lack of change management as a major factor in unexpected product variation after the company released substandard product under a deviation instead of using change control.

For manufacturers, change doesn’t have to be so risky. With the right change management tools, companies can execute change effectively and efficiently, with full visibility into the risks and benefits of proposed changes.

To see how, this article explores:
• The basics of the change management process
• Why change management is essential
• How change management tools in a quality management system (QMS) can streamline the process while mitigating risk

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