E signatures on Engineering Change Notes AS9100 / AS9116

#1
Hi

Does any have any experience or know it it is acceptable to use E signatures on engineering change notes in an AS9100 / AS9116 compliant system?

I am introducing a simple system to our mainly build to print machine shop and want to keep things as straight forward and paper free as possible.

Many Thanks
 
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Al Rosen

Holed-up in a Hotel in South Florida
Staff member
Super Moderator
#2
Hi

Does any have any experience or know it it is acceptable to use E signatures on engineering change notes in an AS9100 / AS9116 compliant system?

I am introducing a simple system to our mainly build to print machine shop and want to keep things as straight forward and paper free as possible.

Many Thanks
Last paragraph 7.5.3.2
When documented information is managed electronically, data protection processes shall be defined (e.g., protection from loss, unauthorized changes, unintended alteration, corruption, physical damage).
You haven't stated what "a simple system" is, but address each of these in your system and you should be ok. I used a system that applied a signature based on the user login.
 
#3
Hi Yes in terms of simple it is an Excel form that on completion is sent to the persons on the approval list (using active x control and a bit of code), this is then reviewed, signed and sent back to the originator. In a round about way in meets the requirements of 7.5.3.2 as the approval list can only be changed in the code and email is only obtainable via user log in, the completed forms are stored on a secure drive. AS9100 re cert !! soon so will see how it goes.
 

Al Rosen

Holed-up in a Hotel in South Florida
Staff member
Super Moderator
#4
Hi Yes in terms of simple it is an Excel form that on completion is sent to the persons on the approval list (using active x control and a bit of code), this is then reviewed, signed and sent back to the originator. In a round about way in meets the requirements of 7.5.3.2 as the approval list can only be changed in the code and email is only obtainable via user log in, the completed forms are stored on a secure drive. AS9100 re cert !! soon so will see how it goes.
BTW, nowhere in AS9100D is sign or signature stated. I would say that a signature is not a requirement, only who authorized the change.
 
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