Managing the Design History File
CAPA (Corrective and Preventive Action), NC (Nonconformance), and CEM (Customer Experience Management) are key components in the Design History File (DHF) for medical devices.
Including Objects in the DHF
If an object does not have the DHFCategory attribute assigned to it, it will automatically be considered part of the DHF.
The presence of the DHFCategory attribute is used to determine whether an object should be excluded from the DHF. If the attribute is missing or not defined for a particular object, that object is included in the DHF by default.
Excluding Objects from the DHF
You can exclude any object, including CAPA, NC, and CEM from the DHF by adding and configuring the DHFCategory attribute.
To exclude, do the following:
• Determine the objects to be excluded from the DHF. This includes CAPA, NC, and CEM.
• Add the attribute DHFCategory to each object type. Ensure the attribute is added to the type and left null.
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• While there is a global attribute named DHFCategory within the QMS_PDS, it is recommended to use a local IBA instead.
• The internal name for the DHFCategory attribute must have the upper and lowercase letters matching DHFCategory.
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