Technical File Locations - Class I and Class IIa Medical Devices

M

medic61

I need your feedback for a few questions relating to our technical files (Class I and Class IIa devices)
1. can technical files be in an electronic format? I have kept hardcopies since the beginning but space is beginning to be an issue.
2. do the technical files, if retained in hardcopy, have to be onsite? We have several locations and managment is considering one location to hold the files.
Thanks!
 
S

SuperGirl

Yes, technical file can be kept in an electronic format as long as they are secure and you have a reliable back up system. (I would hate to have the system go down and have no access to the file or have the files lost). If you do keep a hard copy, to my knowledge they don't have to be kept on site, but have to be readily available. What we do is have hard copy kept and maintained but also scanned electronic copies as well. We are trying to move to just electronic...
 
K

KaCey1

Are specific SOPs required for the retention of documentation etc.?

Thanks!
 
Top Bottom