Since the DHF is important for both informative purposes and audit it is essential that the file maintain accurate information as a “living document”. The best step towards this is having a dedicated team in the product development phase assigned this task. In larger companies the roles that employees have are multi-purpose and there are dedicated teams for reviewing and ensuring that information is accurate. This is true for most lifecycle management roles ranging from design controls to change controls. Therefore, the best course of action is ensuring that employees oversee the accuracy of the DHF file. While an internal audit is a good idea if there is any doubt in the accuracy of design control files, it should be avoided as a last ditch effort. Personally I have been through some internal audits as a preemptive measure and from my experience it drains a lot of resources away from key projects as an internal audit is just as thorough and can take a great amount of time and effort.