System Suitability Testing

Validation is a key GLP/GMP requirement in analytical laboratories nowadays. This requirement is divided into the validation of equipment (chromatograph and PC) and the validation of methods. SST verifies the parameters achieved by measuring on a validated instrument using a validated method.

The most frequent parameter monitored is Analysis Reproducibility, where the standard deviation of monitored parameters must not exceed the specified range.

SST Extension provides tools for the Performance Qualification (PQ) and, together with the Validator, also for the Operational Qualification (OQ).