KEY ELEMENTS OF YOUR

DESIGN HISTORY FILE

This is an extra resource to go along with the original article:
How to Prepare your Design History File (DHF) for an FDA Inspection

When FDA comes to conduct an inspection, they will want to examine your design
history file and your design controls procedure. If you are concerned at all about your
design controls procedure prior to an FDA visit, it’s a good idea to conduct a GAP
analysis to understand where there may be issues.

Here are the key parts to your design history file:

Design plan

User needs

Design inputs

Design outputs

Risk analysis, including hazard identification

Human factors analysis

Design verification, with acceptance criteria

Design validation, with acceptance criteria

Design changes

Software validation—if applicable

Design reviews

Design transfer

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