L
Laura Halper
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.
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.