The total osmolality of aqueous solutions is determined by comparative measurements of the freezing points of pure water and of solutions. Whereas water has a freezing point of 0°C, a solution with saline concentration of 1 Osmol/kg has a freezing point of -1.858°C.
OsmoXpert comply with 21CFR part 11 norms
Desktop based GUI application to interface osmometer and capture live test results in a non-networked environment
Display and store the recorded data and save it securely
Capability of Data Logging, Data Management, Statistical Calculations, Data Storage - Retrieval and Quality Control & Calibration data records retention
Has multiple system access controls, such as User Authentication, password controls, and role-based access, defined as per privileges. Example: Operator, Reviewer, Approver and Administrator
Secure and time-stamped Traceability and Audit Trail for actions undertaken on the application
Printing of reports with e-records and digital e-signatures (Reviewer/Approver)
Any error codes generated during testing are also logged and displayed on screen to review. (No delete or edit possible)
All data and settings can be backed up in encrypted form. And possible to restore software using this backed up data securely