Metrohm^® 841 Volumetric Karl Fischer Titrando^®

Traceability and security

GLP, GMP and 21 CFR Part 11 are becoming increasingly important in day-to-day laboratory life. Titrando allows strict control of rights of access using login and password. The FDA 21 CFR Part 11 requirements regarding «electronic signature» and «electronic record» are fulfilled, and electronic records are protected against accidental or intentional alteration for complete traceability. For long-term archiving, a machine-readable PC/LIMS report is available (Lab Link is required for a Touch Control system).

The Titrando system is entirely oriented toward quality management in the laboratory, and it offers the following possibilities:

• If the instrument has been programmed accordingly, it will remind you about any validation or service work that is due
• You can enter limits for results, which will be checked and noted after each determination
• The standardization value of the titrant can be monitored as a function of time in both tabular form or as a graph
• The «calibration history» of the sensors can be called up; alterations to the sensor caused by aging can be recognized before they affect the results
• All changes to the methods and results are documented and versioned; traceability is ensured
• A full audit trail is available on Titrando
• A self-diagnosis each time Titrando is switched on