How to document Corrections made to a Medical Device History File



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

Problem Solver
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.
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