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krp76 replied to the topic How to ensure your DHF is audit ready ? in the forum Introduction to Design Controls 7 years, 4 months ago
Ensuring that your DHF is constantly updated is the best practice in ensuring that it will have all the necessary documents during an audit. As discussed in the past 2 weeks of class the DHF is a living document and as such everyone involved on the team should have access in editing and updating the document in order to ensure proper inputs. The focus in industry is shifting towards quality management systems that are specifically designed in order to ensure compliance to these FDA mandates in design controls. With quality management systems it becomes easier for a multi functional team across different regions to be updated and follow the guidelines of a DHF as they can upload, review, and sign the necessary documents remotely and everything is logged in the system so that the project manager can have clear visibility on tasks that are completed and remaining. This utilization of QMS is probably the best insurance in maintaining accurate design controls.