Glossary Term: Device history record (DHR)

The Device History Record (DHR) is a collection of records containing the production history of all versions of a product. The DHR includes the serial and lot numbers of the products produced, and any complaints or issues that are lodged against the product.

The DHR may include corrective action, preventative action (CAPA) records. These records describe any investigations, corrective and preventive actions and details about how the corrections were made.

A DHR may be required to meet regulatory measures in the production of certain products including medical devices.

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