SigmaTech is a software for achieving objectives of QbD. It is useful for Designing and building quality into the process using DOE technique.
The statistically planned experimental data will be analysed by this software to build the statistical/mathematical model and provide various simulation techniques for optimal design of the process. This software is useful for applications in Research & Development of API(active pharmaceutical ingredients), Pharmaceutical formulations, Biotechnology Process, Contract Research work, Chemical Process and Analytical Research work.
Some of the salient features of this software are:
Helps in screening for the vital few variables
Helps in Robust Process designwith cost optimized
Helps in process validation
Enables Six Sigma Processdevelopment
Regulatory compliance with21 CFR part 11
Screens cost effective alternative materials
Identifies thekey factors affecting a process consistency
Balances multiple output characteristicsto achieve desirable out comes
Significantlyreduces the rejections to improve the bottom line of an organization