Q
QUALITYTRAINER
Hi,
Basic question. I can't find anything in ISO 13485 or FDA QSR that requires a signature or initials on a vaulted hard copy of a mgt review minutes (which contains all of the slides, CAPAs etc ... from the meeting). I can see an auditor asking 'how do you approve your quality records'. Even with these records not viewable to FDA inspectors, I'm surprised that this isn't specifically stated (even in a guidance document).
I've looked at ISO 14969 (the guidance for ISO 13485). Not the FDA QSR Preamble.
Does anyone have any thoughts on this?
Thanks
Basic question. I can't find anything in ISO 13485 or FDA QSR that requires a signature or initials on a vaulted hard copy of a mgt review minutes (which contains all of the slides, CAPAs etc ... from the meeting). I can see an auditor asking 'how do you approve your quality records'. Even with these records not viewable to FDA inspectors, I'm surprised that this isn't specifically stated (even in a guidance document).
I've looked at ISO 14969 (the guidance for ISO 13485). Not the FDA QSR Preamble.
Does anyone have any thoughts on this?
Thanks