<< Click to Display Table of Contents >> Navigation:  FAQ > Water Activity > Devices > HygroLab FAQ > 3. I already bought a HygroLab. Can I also use the HygroLab validation documents (HYGROLAB-VAL-DOC) for my HygroLab?

Yes, you can.

 

For that you need to update your HygroLab to the newest software version, because the validation document (HYGROLAB-VAL-DOC) is normally only available for the newest HygroLab software version. So please follow the steps in the Update Software to make sure you have the newest software version.

 

From the Software Version 2.7.0.0 the HygroLab is FDA 21 CFR Part 11 and EU Annex 11 compliant. To be fully FDA 21 CFR Part 11 and EU Annex 11 compliant the user must carry out a validation, which can be done with the help of the IQ/OQ template (included in order code HYGROLAB-VAL-DOC), which can be purchased separately from Rotronic.

 

Warning: Once the HygroLab has been validated, the device cannot be updated. Otherwise, the entire device must be revalidated with the new version and with a new validation document (IQ/OQ template) suitable to the new HygroLab Software version.