Question: Is it acceptable to fill out a form electronically for a medical device? This is a product acceptance form that was done in Word. The operator would still print out a paper copy and add their signature manually. He just wants to fill in the data electronically.
The only problem I see is that the form is in Word and the content is not locked. Therefore the content of the form could be changed. If the form was modified to only allow data entry into the fields I would think this would be acceptable.
The form is customer supplied. Is it recommended to go back to my customer and tell him what I want to do with his form?
Any comments or previous personal experience, especially in regards to being reviewed by medical device regulators?
The only problem I see is that the form is in Word and the content is not locked. Therefore the content of the form could be changed. If the form was modified to only allow data entry into the fields I would think this would be acceptable.
The form is customer supplied. Is it recommended to go back to my customer and tell him what I want to do with his form?
Any comments or previous personal experience, especially in regards to being reviewed by medical device regulators?