How does your organization store documents for Class I and Class II Medical Devices?

J

jt1507

#1
Looking for thoughts on Class I and Class II docs (DHR, DMR): How is your organization storing these? Waterproof folders? Sprinkler-free room? Water-tight file cabinet, etc.?
 
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SteveK

Trusted Information Resource
#2
Re: How does your organization store documents for Class I and Class II Medical Devic

All my Technical Files (EU class I, IIa & IIb) etc are stored electronically (pdfs) on our server, these are backed up every 24 hours both on-site by ourselves and off-site by our IT provider. I do keep paper copies, but these are getting essentially redundant, especially where the file size is getting rather high e.g. 400+ pages.

I hope this helps.

Steve
 
I

isoalchemist

#3
Re: How does your organization store documents for Class I and Class II Medical Devic

Although I think the move should be to electronic with Steve's dual back-up policy past practice has been Fire proof cabinets. I also was involved with one organization that basically had a large bank vault built into their facility solely for Engineering drawings and DHF.
 
M

maaquilino

#4
Re: How does your organization store documents for Class I and Class II Medical Devic

The majority of companies I've worked for stored the original paper hard copies in fireproof cabinets in locked rooms. There were sign out sheets if anyone needed to take the documents out for any reason. The paper documents were also converted into pdfs; the file folder containing these pdfs was held on a secure network drive and access was handled by permissions. CDs were also made of these pdfs (one CD would stay with the original hard copies, and one or two other copies would be held by quality and management. After a few months the paper copies with their CD would be packed up and sent to Iron Mountain for storage. Might sound like overkill, but when you're trying to find documents from a past project and can't, you learn to ensure you won't have that problem in the future.
 
S

SuperGirl

#5
Re: How does your organization store documents for Class I and Class II Medical Devic

We use a fire proof cabinet. (at least I believe it's fire proof :confused:) And we are slowly moving to electronic file by scanning everything in to pdf.
 
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