We are a 13485 certified contract manufacturer, and some of the devices we make components for, have a lifetime of over 30 years. All of our records for the past 4 years or so, are both scanned, and stored in hard copy format, however, not in fireproof cabinets. My understanding is that if no electronic files are stored and backed up, paper files must be maintained in fireproof cabinets. If electronic records are maintained, they must be backed up, and retrievable for at least the lifespan of the medical device, which in some of our cases, is over 30 years.
Our current backup system can retrieve documents only for a rolling 24 month period. If you have similar requirements, how does your company handle backups, etc., so that these records can be retrieved so far into the future? Do you save one tape from each year? What if I file a record today, it somehow gets deleted 6 months from now, but we don't realize it until we try to retrieve it 5 years from now?
I have a meeting scheduled with my company president, and our IT service provider next Tuesday, and would like to be able to propose some ideas, based upon what others in our industry are doing.
As always, thank you so much for your input!
Our current backup system can retrieve documents only for a rolling 24 month period. If you have similar requirements, how does your company handle backups, etc., so that these records can be retrieved so far into the future? Do you save one tape from each year? What if I file a record today, it somehow gets deleted 6 months from now, but we don't realize it until we try to retrieve it 5 years from now?
I have a meeting scheduled with my company president, and our IT service provider next Tuesday, and would like to be able to propose some ideas, based upon what others in our industry are doing.
As always, thank you so much for your input!