Saving QMS documents in cloud drive - Compliance with ISO 13485

#1
Hi everyone,

If a company keeps QMS documents in a cloud drive (e.g. Microsoft OneDrive), is this out of compliance with 13485? If so, what sort of work can they do to improve this process? Are there small startups that keep their documents all in a cloud drive? ( OneDrive, GoogleDrive) as their electronic management system (as in without printing anything out)?

Thanks!
 
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yodon

Staff member
Super Moderator
#2
The requirements are that the documents are adequately protected, available at points needed, etc. so if you have controls in place to ensure that the requirements are met (no unauthorized changes, availability, etc.), there should be no reason why keeping them there would be out of compliance. Review the Document & Record Control requirements and see if you can defend the approach.
 

amadisonr

Inactive Registered Visitor
#3
For me, the cloud is a tale of caution. How do you protect your data, and how likely or available is the data when retrieved.
As part of the older workforce, it makes me nervous, but I am not a tech wizard with all the answers. Coming from a government contracting business, aerospace, it is hard to feel confident that the level of protection is adequate. Security and protection of data is huge for competitive business as well. I am not a firm believer in the cloud but I am sure it can be set up correctly and the data should be compliant.
 

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#4
Actually a strong defense is that companies with cloud services have a business interest in keeping the data secure and you probably cant say that about other methods. For example, I worked for the government. The government has no business interest in keeping data safe. Its merely a requirement so if they have a failure they lose NO BUSINESS. Google on the other hand....
 
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