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  • bb254 replied to the topic How to ensure your DHF is audit ready ? in the forum Introduction to Design Controls 7 years, 7 months ago

    Within the medical industry it is crucial to always have the DHF updated as the progress of the project moves forward. A way to make sure that your documents within the DHF are ready for an audit is to have internal audits or a mock FDA audit. At the medical company I work at right now, we already had a mock FDA audit, ISO audit and now an internal audit within the last 3 months. Therefore, we can see our flaws and fix them before we get an FDA audit. One concept that our company instills in terms of documentation is that DHF is a living document, therefore anytime a document is updated it is mandatory for us to update other documents associated with the project. By doing so, the DHF will always be updated. However, people do slack in this category due to time restraints, but it is a great way to prepare for audits. Including a traceability matrix for design controls so that an auditor can see the relationship and flow between the design controls.