The Design History File (DHF) is one of the first documents an FDA inspector will ask for during an FDA audit. To that end, it is the duty of the internal team to keep the file always up to date. A DHF audit is an internal audit performed to ensure that all elements of the design process are complete and present within the file. A DHF audit can be performed using CQ’s Product Design Management Solution. Using the solution, an auditor can focus on verifying two areas of a Design History File (DHF)