When operating according to quality management systems (e.g. according to GxP or ISO guidelines), statistical assessment of the analytical procedures used is very important. This includes for instance validation of analytical methods, analytical stability studies, method robustness studies, estimation of measurement uncertainty, method transfer and many other assessment steps during the whole life cycle of the analytical method. NeoLiCy® software project is designed to fulfill the requirements of all these steps according to proven and established recommendations and regulations.
- Software for comprehensive statistical assessment of analytical methods
- Powerful project management
- Easy data input and automatic calculation
- Automatic report compilation
- Validated and fully FDA 21CFR part 11 and EU GMP Annex 11 compliant
NeoLiCy® is a configurable software designed for statistical assessment of any kind of analytical method. It contains ready to use templates related to the configuration of the statistical tests and associated calculations. These templates comply with the guidelines and recommendations for pharmaceutical, cosmetic, agro-foodstuff, environmental and chemical industry. For ease of use these templates are pre-configured and additionally the user may create and save own templates. This high degree of versatility enables NeoLiCy® Release 1 to be used for the validation of all analytical procedures in any kind of industrial activity.
Certificazioni: NeoLiCy® is developed with regard to international recommendations and regulations on assessment of analytical methods. It is based on the ICH recommendations (ICH Q2(R1) on method validation, ICH Q8 on Quality by Design, …), EMA, FDA, USP, EP guidelines and ISO standards related to the subject.