Managing Change Control to Comply with FDA and EU Regulations

Uncontrolled changes to a pharmaceutical or medical device product have the potential to affect public health and safety. To keep change in check, the FDA and ISO have developed stringent change control regulations mandating that companies document change and handle it according to approved company policies. Learn how an electronic change management system addresses the common challenges of change control and helps manufacturers increase operational efficiency while avoiding recalls, liability actions and regulatory violations.

 



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