JoshuaFroud
Involved In Discussions
Hi All
First post here after lurking for a number of years. I have recently moved to a new job at a much smaller and less mature company and I am currently the only Quality Professional, due to this being asked a lot of "can we...." questions.
Today's question I have not been able to answer as its not a situation I have come across before.
The situation is; recently some management has been transferred to a site in a different country (Site 2) with the majority of the working staff at the original site (Site 1). This has caused some problems with the signing and authorization of documents requiring a signature.
The current practice is to fill in and print the document at Site 1, scan this and email to Site 2 for them to print, sign and scan back. The document with two signatures on is then printed and put on file. This leaves three copies of the document in existence, none of which actually have two wet signatures on and the copy on file has none.
I am unsure if this is truly compliant with any of the relevant regulations (9001, 13485, CFR 820) we fall under. Can I please ask for comment?
In addition, for those of you that work in a similar situation how do you address this issue?
Thanks!
First post here after lurking for a number of years. I have recently moved to a new job at a much smaller and less mature company and I am currently the only Quality Professional, due to this being asked a lot of "can we...." questions.
Today's question I have not been able to answer as its not a situation I have come across before.
The situation is; recently some management has been transferred to a site in a different country (Site 2) with the majority of the working staff at the original site (Site 1). This has caused some problems with the signing and authorization of documents requiring a signature.
The current practice is to fill in and print the document at Site 1, scan this and email to Site 2 for them to print, sign and scan back. The document with two signatures on is then printed and put on file. This leaves three copies of the document in existence, none of which actually have two wet signatures on and the copy on file has none.
I am unsure if this is truly compliant with any of the relevant regulations (9001, 13485, CFR 820) we fall under. Can I please ask for comment?
In addition, for those of you that work in a similar situation how do you address this issue?
Thanks!