Storage Cabinets for Quality Documentation (Procedures and Records)

L

Laura Halper

#1
Hello all,
I have advised a small start-up device company that they should store quality documentation (procedures and records) in fire-and-water-proof cabinets. They are balking at the cost of the cabinets, which apparently run about $5,000 apiece (they need two at this time, more later.)

I believe that medical device manufacturers routinely use such cabinets. But have any of you had actual experience with the FDA either requiring such cabinets, or specifically saying that it's OK to store paper records in non-fire/water-proof cabinets? What about storing in binders in a book shelf?

I know that NOT using fire-and-water-proof cabinets is a risk. But my question is whether the FDA specifically requires (e.g., has given 483's or Warning Letters) such cabinets be used.

The company cannot afford an electronic system, although procedures are scanned and kept on computer. But the original hardcopy is the official version.

Thanks for your input.
 
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Wes Bucey

Prophet of Profit
#2
Re: Storage Cabinets

Hello all,
I have advised a small start-up device company that they should store quality documentation (procedures and records) in fire-and-water-proof cabinets. They are balking at the cost of the cabinets, which apparently run about $5,000 apiece (they need two at this time, more later.)

I believe that medical device manufacturers routinely use such cabinets. But have any of you had actual experience with the FDA either requiring such cabinets, or specifically saying that it's OK to store paper records in non-fire/water-proof cabinets? What about storing in binders in a book shelf?

I know that NOT using fire-and-water-proof cabinets is a risk. But my question is whether the FDA specifically requires (e.g., has given 483's or Warning Letters) such cabinets be used.

The company cannot afford an electronic system, although procedures are scanned and kept on computer. But the original hardcopy is the official version.

Thanks for your input.
Then:
For years, organizations kept backup hard copies offsite to guard against accidental destruction. When I first started doing it back in 1972, I invested in a small rubber stamp that said something like:
"Certified true copy of the original.

Date _______________________

Attest: _____________________"

and had it affixed, dated, and signed in red ink to copies we kept in an offsite storage facility.

Now:
It seems to me a computer, scanner, and cloud storage is a whole lot cheaper and simpler today than investing in fireproof cabinets and certainly a lot easier and simpler than what I did 40 years ago. Certainly, simple security measures are available to prevent alteration or loss of important documents.
 

Statistical Steven

Statistician
Leader
Super Moderator
#3
Hello all,
I have advised a small start-up device company that they should store quality documentation (procedures and records) in fire-and-water-proof cabinets. They are balking at the cost of the cabinets, which apparently run about $5,000 apiece (they need two at this time, more later.)

I believe that medical device manufacturers routinely use such cabinets. But have any of you had actual experience with the FDA either requiring such cabinets, or specifically saying that it's OK to store paper records in non-fire/water-proof cabinets? What about storing in binders in a book shelf?

I know that NOT using fire-and-water-proof cabinets is a risk. But my question is whether the FDA specifically requires (e.g., has given 483's or Warning Letters) such cabinets be used.

The company cannot afford an electronic system, although procedures are scanned and kept on computer. But the original hardcopy is the official version.

Thanks for your input.
Most companies use an off-site storage facility such as Iron Mountain to store originals. As Wes mentioed a true copy can be kept on site. For a small company I would think such cabinets are overkill versus using an off-site storage facility.
 
L

Laura Halper

#4
Thanks for your suggestions.

Wes, does scanning and then cloud-storing require validation to Part 11 with time stamped audit trails, etc?
 

Wes Bucey

Prophet of Profit
#5
Thanks for your suggestions.

Wes, does scanning and then cloud-storing require validation to Part 11 with time stamped audit trails, etc?
I'm not currently aware of such requirement for anything other than pharmaceuticals, and maybe with devices involving nuclear radiation.

At the point your client wishes to proceed, it would be well to request a guidance letter from FDA to confirm this. I am not prepared to state this backed up by formal citations and interpretations to FDA regulations unless retained as a consultant. I offer this merely as an anecdotal comment based on my memory.
 
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