Each time that this titrator is switched on it carries out a self-diagnosis, and if programmed accordingly it will also provide reminders about any validation or service work that is due
Compatibility and traceability GLP, GMP, 21 CFR Part 11 are becoming increasingly important in day-to-day laboratory life.
Metrohm says its Titrando system is entirely oriented towards Quality Management, and each time that it is switched on it carries out a self-diagnosis.
If it has been programmed accordingly then the instrument will provide reminders about any validation or service work that is due.
Users can enter limits for results; their observance will be checked for each determination.
The titer of the titrant can be monitored as a function of time in both tabular form or as a graph, similar to a control card.
The calibration history of the sensors can be called up.
This means, for example, that alterations to the sensor caused by aging can be recognised before they affect the results.
All changes to the methods are documented; traceability is guaranteed.
The Titrando allows strict control of rights of access using login and password.
The requirements defined in FDA Regulation 21 CFR Part 11 regarding electronic signature and electronic record are fulfilled in the stand-alone system using Touch Control as well as in the version controlled via PC, says Metrohm.
This also applies to the other points contained in this regulation, namely the protection of electronic records against accidental or intentional alteration and complete traceability.
The Titrando with Touch Control is said to be the only stand-alone titration system with Audit Trail.
For long-term archiving a machine-readable PC/Lims report is available.
