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  • akashranpura replied to the topic How to ensure your DHF is audit ready ? in the forum Introduction to Design Controls 7 years, 7 months ago

    The DHF is an integral part of the project design and development aspect. The DHF must be a set of documents that clearly states the intricacies of the product. The DHF must be continually updated in order to have the most optimal product. There should be a team or a specific person in charge of ensuring the DHF is regularly updated. People need to be proactive on the auditing team to ensure that the company never falls behind. The documents must be accessible by all team members so there is not a long process to make changes. Instead, the document can be continually improved by all members of the production team.