How to document Corrections made to a Medical Device History File

[jollybear]

HI, is there an FDA regulation or ISO standard concerning how to documentation correction made to a Device History File? Currently my company allows anyone to change the initial entry entered with just an initial and date of the new person changing the original documentation.

 

[Ronen E]

There are, in the regulations, no special document control requirements related to the DHF.

General document control requirements, and the contents of your own document control SOP, apply.