Hard Copy Documents not in Fireproof Cabinets - Document Storage Questions...

We're 13485 certified, and we store hard copies of all of our documents on-site, and they are not in fireproof cabinets. We also scan most of our critical documents DMR, DHF, Purchasing and inspection docs, etc., and store them on-site on a server. We have a back-up protocol for all files on our server, and back-up media is maintained off-site, but the media is overwritten after one year. My understanding is that this presents a major concern. Which leads me to a few questions:
1. Am I correct in assuming that since our file cabinets are not fireproof, that our electronic back-up files must be available for the life of the medical devices that these records pertain to?
2. If so, can anybody offer cost effective solutions that you may be using for such document storage (for either hard or soft copies)?
3. If I order material from someone like 3M, and they send a C of C (Not the actual data), and I file that cert along with my docs, and 10 years later, an FDA investigation ensues, and we need to provide data, would 3M still have their actual lab results, if we didn't specify in our PO that it would need to be retained? (I'm just using 3M as an example, but the question would apply to all of our suppliers).
Any answers to any of these questions would be greatly appreciated.
THANKS!

Good day, as it is the beginning of the weekend in the U.S., for now let me please refer you to a thread titled Retention of records - Original Order Form vs. Computer Entry record - ISO 13485 and I invite you to explore the related discussions viewable as links at the bottom of the web page you are viewing. If this is not satisfactory we can certainly continue the discussion.

As you mentioned, you already keep copies of your records off-site. Why is there a need to overwrite that data on a yearly basis? Your ability to scan all documents means that a continual record of all documentation is possible and more than likely inexpensive.

Of course there will be sensitive material that could be held in as simple a place as a "bank deposit box".

Keep it simple, sane, effective and accessible.

Al...

cubix rube said:

We're 13485 certified, and we store hard copies of all of our documents on-site, and they are not in fireproof cabinets. We also scan most of our critical documents DMR, DHF, Purchasing and inspection docs, etc., and store them on-site on a server. We have a back-up protocol for all files on our server, and back-up media is maintained off-site, but the media is overwritten after one year. My understanding is that this presents a major concern. Which leads me to a few questions:
1. Am I correct in assuming that since our file cabinets are not fireproof, that our electronic back-up files must be available for the life of the medical devices that these records pertain to?
2. If so, can anybody offer cost effective solutions that you may be using for such document storage (for either hard or soft copies)?
3. If I order material from someone like 3M, and they send a C of C (Not the actual data), and I file that cert along with my docs, and 10 years later, an FDA investigation ensues, and we need to provide data, would 3M still have their actual lab results, if we didn't specify in our PO that it would need to be retained? (I'm just using 3M as an example, but the question would apply to all of our suppliers).
Any answers to any of these questions would be greatly appreciated.
THANKS!

Click to expand...

You write: My understanding is that this presents a major concern.
Who gave you this understanding? I'm not aware of a definitive citation to a regulation or Standard which says this.

1. Am I correct in assuming that since our file cabinets are not fireproof, that our electronic back-up files must be available for the life of the medical devices that these records pertain to?

Click to expand...

That would be keeping duplicate electronic records - no requirement for that.

3. If I order material from someone like 3M, and they send a C of C (Not the actual data), and I file that cert along with my docs, and 10 years later, an FDA investigation ensues, and we need to provide data, would 3M still have their actual lab results, if we didn't specify in our PO that it would need to be retained? (I'm just using 3M as an example, but the question would apply to all of our suppliers).
Any answers to any of these questions would be greatly appreciated.
THANKS

Click to expand...

If you think you need the actual data, request it when you order! Otherwise, specs on material can be done on the suspect material ten years in the future with lab tests to see if it does, indeed, match the C of C.

the essence of record keeping is to ask some of these questions

1. will I ever need this record in the future?
2. if I need it and don't have it, can it be reconstructed? (this would be in the area of performing a chemical/physical analysis in lieu of a record.) In legal fact, this might be necessary anyway since there are a number of cases where the supplier gave faulty data (on purpose or accident) at the time of delivery