R
Hi,
Here's an interesting question:
My company is changing over to a new computer system and we are trying to eliminate as much paper use and storage as possible. We have customers fill out an order form and mail it to us which defines the customer requirements for the product. My question is; if we enter all of the information from the order form into the computer system, do we still need to keep the original order form (definition of customer requirements) for the lifetime of the medical device?
I have taken the stance that we do need to retain the original order form. The plan now is to scan each order form and store it electronically to save storage space. The scanners required to do this are quite expensive. Before we go out and spend a lot of money on a fancy scanner, I was wondering if anyone can confirm that we have the correct understanding of the requirements of ISO 13485:2003.
Any help would be much appreciated!
Here's an interesting question:
My company is changing over to a new computer system and we are trying to eliminate as much paper use and storage as possible. We have customers fill out an order form and mail it to us which defines the customer requirements for the product. My question is; if we enter all of the information from the order form into the computer system, do we still need to keep the original order form (definition of customer requirements) for the lifetime of the medical device?
I have taken the stance that we do need to retain the original order form. The plan now is to scan each order form and store it electronically to save storage space. The scanners required to do this are quite expensive. Before we go out and spend a lot of money on a fancy scanner, I was wondering if anyone can confirm that we have the correct understanding of the requirements of ISO 13485:2003.
Any help would be much appreciated!