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Offsite storage of QMS documents

duff999

Involved In Discussions
#1
Currently we are developing a eQMS (Cloud Based) and have questions regarding backups, off-line and off-site storage. I would be interested to hear how others are handing backups and offline and offsite storage.

Thanks
 
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indubioush

Quite Involved in Discussions
#2
Since you are going with a cloud based QMS, it makes sense that you would also have your backups in the cloud.
What exactly do you mean by "off-line and off-site storage"? Are you talking about storage of your old paper records or storage of your eQMS backups?
What risk are you trying to mitigate?
 

duff999

Involved In Discussions
#3
Thanks for the feedback. I think I was looking way down the road, perhaps our current eQMS provider went out of business, I wanted to be sure I had a current backup available. Then I was thinking further if I should store this backup offsite.
 

Tagin

Trusted Information Resource
#4
Thanks for the feedback. I think I was looking way down the road, perhaps our current eQMS provider went out of business, I wanted to be sure I had a current backup available. Then I was thinking further if I should store this backup offsite.
It seems reasonable to consider offsite storage. For example, Amazon Glacier is low-cost and is intended for very infrequent need to access backups.

You might need to work with your eQMS provider to see if these backups can be automated to send to cloud storage. Some might only be manually initiated and/or only download to your PC.

In our case, our QMS is onsite and backed up locally and on offsite backups. We don't have the bandwidth to use the cloud for backups. But we do use Amazon S3 for offsite BCP information.

A concern about cloud storage like S3, OneDrive, etc. is that if they are misconfigured then they can become publicly visible, which could be a nightmare. So, managing access permissions needs to be assigned to only a very responsible small group of people.

Also...if you work with ITAR-related information, or other information considered sensitive by a government, etc., you may need to be careful about the cloud host's ownership as well as the hosting servers locations.
 

James

Involved In Discussions
#5
I had similar questions to my eQMS provider. Make sure all data fields can be exported for backups, and that all data can be exported / mapped for use in another system should you change provider in future. Critical questions to ask at system procurement stage. I use the eQMS for all system management but all written documents are backed up (before loading onto the eQMS) on my organisations network drive, which is itself backed up.

James
 

duff999

Involved In Discussions
#6
I had similar questions to my eQMS provider. Make sure all data fields can be exported for backups, and that all data can be exported / mapped for use in another system should you change provider in future. Critical questions to ask at system procurement stage. I use the eQMS for all system management but all written documents are backed up (before loading onto the eQMS) on my organisations network drive, which is itself backed up.

James
Thanks James, great info
 

James

Involved In Discussions
#7
On the subject of eQMS, another issue I haven't yet resolved is controlling docents that people want to write in electronically. For example, a form that is perhaps created in MS word, and that you want to keep in MS word so staff can type into it (thus perhaps creating a record). eQMS systems typically add control by converting word documents into PDF and adding a watermark.
This has created a bit of a headache for me! The workaround is to have a separate word version of the controlled document controlled in a different way, which is far from ideal..

James
 

duff999

Involved In Discussions
#8
Exact problem I am running into, when printing documents, I am getting 2 pages, one a cover, and the other with the content but both with watermarks.
 

Ninja

Looking for Reality
Staff member
Super Moderator
#9
Haven't seen it mentioned yet, so I figured I'd just throw it on the table...
Connection to the cloud is not 100% stable...especially when a semi takes out the fiber line to the plant (happened at my site, down for 7 calendar days).

What do you do for SDS's (legally required to be available), fill-in forms, highly referenced work instructions, etc. when you can't get to the internet?

Just food for thought...have a plan...
 
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