A Complaint Handling System is one of the most significant components of a GMP Quality Management system.  It is foundational in a regulated company. Effective complaint handling is not only a good business practice it’s a necessary compliant business practice. Why do agencies place so much emphasis on this area?  In a broad sense, customer complaints are a form of communication.  We benefit from communicating with our customers. In the FDA and ISO environments, where quality is primary focus, complaints have a deeper implication. Often, they indicate safety and quality issues.  How do we play this game or more importantly how can we WIN and be successful?

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