Hygrolab 2 in a validated RMS cloud, possible?
Hi All
Is it possible to implement the Hygrolab 2 into RMS, and still be compliant? (GxP)
Is it possible to implement the Hygrolab 2 into RMS, and still be compliant? (GxP)
Hi Emil,
The HygroLab C1 is integrated into RMS via the RMS-CONVERTER-100 (you can see it in the Rotronic Monitoring System cloud: https://rms.rotronic.com/RMS/Login.aspx. User name: guest. Password: 12345678).
The HygroLab 2 can be integrated into RMS if it has a TCP/IP connection (with the RMS-CONVERTER-100).
The software is FDA CFR 21 Part 11/EU Annex 11 conform, nothing to do with the hardware.
The software is developed based upon the GAMP5 guidelines.
If you wish to validate the HygroLab, this is possible, however, the documents will need to be adapted accordingly (this has not been done from our side).
Hope this helps.
Regards,
James
The HygroLab C1 is integrated into RMS via the RMS-CONVERTER-100 (you can see it in the Rotronic Monitoring System cloud: https://rms.rotronic.com/RMS/Login.aspx. User name: guest. Password: 12345678).
The HygroLab 2 can be integrated into RMS if it has a TCP/IP connection (with the RMS-CONVERTER-100).
The software is FDA CFR 21 Part 11/EU Annex 11 conform, nothing to do with the hardware.
The software is developed based upon the GAMP5 guidelines.
If you wish to validate the HygroLab, this is possible, however, the documents will need to be adapted accordingly (this has not been done from our side).
Hope this helps.
Regards,
James
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