Water Activity Devices > HygroLab

NOTE: This features are only available with the Software Version 2.0.0.0 or higher.

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.

Activating FDA Mode

Step 1	To get to the FDA mode or the FDA settings go to "Settings" > "Device settings" > "Local settings"
Step 2	Then click on the top the register which is labeled as "FDA", which is on the right side of the "Local settings". See more about the different HygroLab Modes here: General Settings
Step 3	The FDA settings can be only changed when the HygroLab is in the FDA mode. For that "Use FDA mode" needs to be enabled. After that the user can put (only) numbers into the input window. The X is a placeholder for a number. NOTE: User with "Manage user accounts" rights are not affected by the FDA Mode settings and when using LDAP function (the boxes are gray and can't be configured).
Step 4	When everything is adjusted the way it should be click on the right side below the "Save" button to adopt the changes and to activate the FDA mode. The HygroLab shows on the top the FDA logo, when the device is in the FDA mode.

Password and access controls: An administrator can configure the minimum password length, required character types, password expiration, password reuse restrictions, account lockout after a defined number of failed login attempts, password confirmation before changing settings, and a mandatory reason for changing settings.

Audit trail: Failed login attempts are recorded in the audit trail. Audit-trail entries can include the date and time, action, user, reason for change, and previous and new values. The time-zone designation is not included in the audit-trail entry.

Simultaneous access: An administrator can access the same data while another user session is active.

Data handling: Reports can be stored or sent by email. Direct physical printing is not supported. Data and audit-trail records are stored in the internal database. Their storage paths cannot be selected or changed by the user.

FDA Mode

FDA Mode

Activating FDA Mode

The FDA settings can be only changed when the HygroLab is in the FDA mode. For that "Use FDA mode" needs to be enabled.

After that the user can put (only) numbers into the input window. The X is a placeholder for a number.

NOTE: User with "Manage user accounts" rights are not affected by the FDA Mode settings and when using LDAP function (the boxes are gray and can't be configured).

When everything is adjusted the way it should be click on the right side below the "Save" button to adopt the changes and to activate the FDA mode.

The HygroLab shows on the top the FDA logo, when the device is in the FDA mode.

Audit trail: Failed login attempts are recorded in the audit trail. Audit-trail entries can include the date and time, action, user, reason for change, and previous and new values. The time-zone designation is not included in the audit-trail entry.

Simultaneous access: An administrator can access the same data while another user session is active.

Data handling: Reports can be stored or sent by email. Direct physical printing is not supported. Data and audit-trail records are stored in the internal database. Their storage paths cannot be selected or changed by the user.