V
Viki N.
Hello,
Does anyone out there use IQMS for their ERP system? We switched over to this system almost 3 years ago. At the time, the quality module was not functional. We opted not to get it when it was finally offered due to the "bugs" that would need to be worked out, but now we are considering it again.
The main question I have (if someone is familiar with IQMS) is if the quality module seems to adequately address ISO 13485 & FDA 820 requirements regarding document and record control (4.2.3/4 & 820.40) when dealing with CAR's, Deviations, ECO's, Part Approvals, Calibration, FMEA, etc.
We were given very short notice to check this out so I am looking for opinions from user experience, if possible.
Thanks
Viki
Does anyone out there use IQMS for their ERP system? We switched over to this system almost 3 years ago. At the time, the quality module was not functional. We opted not to get it when it was finally offered due to the "bugs" that would need to be worked out, but now we are considering it again.
The main question I have (if someone is familiar with IQMS) is if the quality module seems to adequately address ISO 13485 & FDA 820 requirements regarding document and record control (4.2.3/4 & 820.40) when dealing with CAR's, Deviations, ECO's, Part Approvals, Calibration, FMEA, etc.
We were given very short notice to check this out so I am looking for opinions from user experience, if possible.
Thanks
Viki