Filling in electronic forms for medical devices

RCW

Quite Involved in Discussions
#1
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?
 
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SuperGirl

#3
As someone who sends forms to be filled out, I make sure that they are secured with only areas that can be filled out, allowed to be altered. This can be done in work. Also, then, if a manufacturer noticed that the form could be changed and requested it, I woud have no problem making the change.
 

yodon

Staff member
Super Moderator
#4
What's the likelihood that the form content would be changed? What's the risk if it is changed? Would it be caught in review?

I would venture to say that this would generally fall under the "typewriter rule" and thus no part 11 concerns. Depending on the answers to the above, maybe no action is necessary. Of course, you could ask for the extra protections but if someone is that bent on chicanery, what's to keep the person from creating an unprotected form? If this is a big concern, you'll still need downstream checks.
 

Michael Malis

Quite Involved in Discussions
#5
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 short answer is "yes".

In my prior life, I used the information supplied and converted it in the document that can not be modified with only "open" limited space that left for inspector/checker to verify the information and sign/dated this document.
 
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