Electronic Distribution of Controlled Documents: Validation required?

W

wwcanoer

#1
Hi,

I am creating the QMS system for a small medical device startup (thus for ISO13485). Our docs are all released by wet ink signatures on paper. We want to scan those and make them available electronically such that they are only considered controlled when viewed online (and thus have "uncontrolled when printed" stated in each footer).

Q1: Does the electronic distribution (viewing) system need to be validated?

Q2: Is it reasonable to use an online hosted file service, like box.net? (most services are continually evolving and adding features, so how to validate that)

Q3: How about using a synchronization solution that delivers the latest controlled doc to each computer, like Nomadesk or Syncplicity. (We are a distributed team that travels a lot, so if I don't provide easy access to controlled docs then people will naturally be using their "illicitly" saved copies).

Thanks in advance for your thoughts.

~Brian
 
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Stijloor

Staff member
Super Moderator
#2
Re: Electronic Distribution of controlled Docs: Validation required?

Can someone help Brian?

Thank you very much!

Stijloor.
 

Ajit Basrur

Staff member
Admin
#3
Re: Electronic Distribution of controlled Docs: Validation required?

I have moved the question to this section to get more directed responses.
 
C

Chance

#5
Hi,

I am creating the QMS system for a small medical device startup (thus for ISO13485). Our docs are all released by wet ink signatures on paper. We want to scan those and make them available electronically such that they are only considered controlled when viewed online (and thus have "uncontrolled when printed" stated in each footer).


~Brian
Q1: Does the electronic distribution (viewing) system need to be validated?

My company is using SharePoint system for our QMS documents. IMHO, as long as you are tracking the versions from V1 to V2 etc. and you have evidence like reason for change noted everytime you revise a document, it is sufficient enough. The main concern is how you manage your documents not the viewing system.

Q2: Is it reasonable to use an online hosted file service, like box.net? (most services are continually evolving and adding features, so how to validate that)
You can use whatever software you want, as long as you have the history of changes and you indicate in the footer that the document becomes uncontrolled once printed, you are safe.

Q3: How about using a synchronization solution that delivers the latest controlled doc to each computer, like Nomadesk or Syncplicity. (We are a distributed team that travels a lot, so if I don't provide easy access to controlled docs then people will naturally be using their "illicitly" saved copies).

That is up to you, as long as you manage them accordingly.
Thanks in advance for your thoughts.
 
W

wwcanoer

#6
Good to hear that you don't think the eDMS system requires validation. I hope that our Notified Body agrees...
 
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