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amandaally1029 replied to the topic How to ensure your DHF is audit ready ? in the forum Introduction to Design Controls 7 years, 5 months ago
I also agree, the DHF documents should always be updated throughout the project. I have not had experience dealing with DHF files but based on what I have learned so far, I think that updating these documents frequently will be beneficial for the future of the project. This document also gives information on what worked and what didn’t through clinical trials. Keeping records of the phases of the project allows for improvement and fresher ideas by reviewing what has already been tested. I think that as soon as new information arises it should be documented as soon as possible. In this way, information isn’t forgotten along the way, and when it needs to be audited, its ready.