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FAQs for Complaint Handling

Frequently Asked Questions for Complaint Handling Patient safety is paramount within the medical device industry. Managing customer complaints is an inevitable, and essential part of quality improvement. Your product is not perfect! And it is a regulatory requirement....

Why Your Document Control System is Obsolete

Why Your Document Control System is Obsolete For many years companies have implemented document control systems that had the ability to manage the version of the document throughout their life cycle. As documents were approved the process would notify users that a new...

Data Integrity – a Document Control Challenge

Data Integrity- A Document Control Challenge The FDA has increasingly observed cGMP violations involving data integrity during inspections. The purpose of the data integrity guidance is to help manufacturers have the tools and systems in place to prevent adulterated...