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