Formal complaint management is a requirement in regulated industries such as medical device and pharmaceuticals under U.S. Food and Drug Administration (FDA) and other international regulations.

The FDA mandates that medical device companies, for example, designate a formal unit for managing complaints, which is required to:
• Log all customer complaints received
• Establish procedures for reviewing and conducting investigations of complaints
• Conduct and document results of investigations
• Report certain adverse events to regulators in compliance with 21 CFR Part 803

Complaint management software simplifies this process with an automated, end-to-end workflow from intake to reporting, helping ensure compliance and maintain a state of audit readiness.

However, the benefits of complaint management go far beyond basic regulatory compliance. Furthermore, these benefits extend to companies in any industry, life sciences or not.

To understand more, let’s dig into the hidden ROI of complaint management and what companies should pay special attention to when evaluating complaint management software.

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