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DHF, DMR and DHR soft copy data validation and verification

DHF, DMR and DHR soft copy data validation and verification

(OP)
I am interested to know if the FDA requires Device Manufacturers to validate files which are created in MS Excel or MS access. If this is dependent on level of complexity of the file created, has FDA published any guide lines as to when you should get the file in question validated? I specifically am questioning files which are used in DHF, DHR, and DMR.

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