Test Report written by hand or electronically

Developer_Germany

Starting to get Involved
#1
My question refers to any standard for medical product development. I just do not know in which of them my question is answered...

Is there a rule for filling test reports e.g. for verification or validation? I often fill out a word document and enter the test results electronlically. At the end this is printed and signed by me (tester).

Is that ok or am I supposed to write my comments and checkmarks and test results by hand and pen on the paper?

Thanks in advance
Frank

By the way: This question refers to European Medical Device Directive and also to FDA rules...
 
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isoalchemist

#3
I've seen it both ways also. When complete and approved I would pdf the report and save that as the "auditable" copy. It may be over kill, but it eliminates the question of changes after approval.:2cents:
 

Ronen E

Problem Solver
Staff member
Moderator
#4
I've seen it both ways also. When complete and approved I would pdf the report and save that as the "auditable" copy. It may be over kill, but it eliminates the question of changes after approval.:2cents:

Hi,

1. PDF is editable with some software.
2. If you rely on electronic documents, FDA may require you comply with part 11.

Cheers,
Ronen.
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#6
We are going through a very comprehensive equipment qualification and process validation program right now. We find it best to to generate the protocols in Word, but "fill in the blanks" for the results by hand...That way it prevents shortcuts like overuse of copy/paste for repetitive results in some tables, which can go awry.

Unless we're using a device that produces and electronic record, like a CMM to verify dimensions of a test coupon. In that case the report is attached to the executed protocol. We won't re-write the results.

If you are signing/initialing on a computer you will be asked by an auditor or inspector at some point if the software you use is validated for signatures.
 
L

Laura Halper

#7
I agree with previous comments. Just want to add that, if you are just scanning the manually-signed Word document and saving as a .pdf file (and not doing any edits to the .pdf file), then Part 11 does not apply. But as ScottK said, if you are signing the document electronically, that's when Part 11 comes into play.
 
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