Thermo Elemental announces an automated system validation package, the Validatorplus, to enhance the efficiency of the new Solaar AA range of instruments
The Solaar Validatorplus generates substantial time and cost savings for analysts working in a regulated environment, by providing fast and proven validation of the Solaar AA systems. The Validatorplus package includes comprehensive documentation and accessories for spectrometer performance validation and system qualification; including installation (IQ), operation (OQ) and performance (PQ) qualification.
Solaar Validatorplus provides all the necessary protocols to ensure proper use and performance of Solaar AA spectrometers and documentary evidence for demonstrating total compliance to regulatory bodies, including the pharmaceutical 21 CFR Part II standard.
The validation process is simplified through automation of the OQ procedure using the new calibration and validation unit (CVU), while the performance qualification user is guided through the wizard-based user interface.
Each step is supported with full working SOPs. All validation results are documented and stored in database format for future inspection and can be printed in the logbook format provided.
In order to protect and qualify validation results, a complete software audit trail and password security system is also provided.
This ensures regulatory tracking from the start of the installation to the retrieval of the data.
