Printed Back Up copy of an Electronic Certified True Copy of Document

doc_controller

Registered
Hi, colleagues! Our laboratory is planning to transition to digitalized documents. Currently, our document control system involves maintaining a master copy, which is a printed certified true copy with original pen signatures from the author and reviewer. Our plan is to move towards digital document releases, involving only electronic signatures from both the author and the reviewer. To ensure access in case of server issues or lack of internet access, we'll also print these electronic copies and store them in a document binder as a back up. What should we refer to these printed copies as? And do you think it's necessary to stamp them with a statement clarifying their purpose?
 

John C. Abnet

Teacher, sensei, kennari
Leader
Super Moderator
Good day @doc_controller
I question the decision to have printed DUPLICATE copies. Is your organization really at risk of losing service?....for a period of time long enough to negatively impact your processes/management system? Who/how will those printed copies be kept current...over time and associate changes?

If your organization MUST, it is common to have a boiler plate statement printed on documents "Printed copies are not to be used and are not controlled" .

Of course, once they're printed and 'out there', actually keeping them current and keeping them up to date is not tenable. And, of course, if they are for back up, then there are intended for use and, therefore, your system must include a mechanism to control them as revisions change.

I'd reconsider.

Hope this helps.
 

Jean_B

Trusted Information Resource
They'll be controlled copies, with issueing and withdrawal controls to be added to your document control process.
Notch one to John in not printing out your whole QMS, excepting the procedures etc. for any safe-shutdown and recovery procedures of your equipment/materials in case of power outage. This will depend on whether you have any back-up power supply units that can run the system while you bring it into a safe state.
Don't care as much about internet outages, unless you have overflowing data buffers (which you probably don't).
 

Bev D

Heretical Statistician
Leader
Super Moderator
I can see having a few (a few) work instructions regarding safe equipment shut down startup. laminated and placed at the equipment. But really will you be doing any work if the power goes out or the ‘internet’ goes down? Think long and hard about what you will be able to do and what you will actually do.

I’ve been in situations where brief server problems have occurred and some manufacturing has continued but was very limited as we had an ERP system to control movement, quality and shipment (orders & billing & paying…)

Added in edit: while you may think that the binder will be kept up to date, it won’t. Out of sight out of mind. Once you go electronic, updating hard copies becomes a low priority to the point of never really updating it. Speaking from actual expereince.
 
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