Design validation, with software validation if applicable.The FDA is looking for the DHF to, “contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part." The FDA will look at your design controls procedure and ensure it includes the following elements: Elements for Inclusion in Your Design History FileĪ DHF is the complete record of the design and development of a device-“complete” is the keyword here. Don’t wait until a surprise inspection to learn that your DHF needs some work. The more proactive you can be, the fewer issues will arise. Device designers are focused on what they do best, not necessarily prioritizing documenting design controls along the way. It’s not uncommon for DHFs to be lacking, especially when the product development process doesn’t have a strong emphasis on regulatory requirements. Creating and maintaining a compliant design history file (DHF) will help ensure that when the time comes, you’ll be ready for an FDA inspection that results in minimal findings. Food and Drug Administration (FDA) inspections are stressful, especially if your documentation isn’t audit-ready.
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