assayModelle

AssayModelle is a software tool designed to facilitate the development and validation of analytical methods, particularly in the field of pharmaceutical analysis. It is developed by the German company Merck KGaA, Darmstadt, Germany. The software is used to create, manage, and execute analytical methods, ensuring that they meet regulatory requirements and industry standards.

AssayModelle supports a wide range of analytical techniques, including high-performance liquid chromatography (HPLC), gas chromatography (GC), and mass spectrometry (MS). It provides a user-friendly interface for method development, allowing users to define sample preparation, separation, and detection conditions. The software also includes tools for method validation, such as linearity, accuracy, precision, and robustness testing.

One of the key features of AssayModelle is its ability to generate comprehensive documentation for analytical methods. This includes standard operating procedures (SOPs), validation reports, and method transfer protocols. The software also supports data management and compliance with regulatory requirements, such as those outlined in the International Conference on Harmonisation (ICH) guidelines.

AssayModelle is used by pharmaceutical companies, contract research organizations (CROs), and academic institutions for the development and validation of analytical methods. It is available as a standalone software or as part of a larger analytical data management system. The software is regularly updated to incorporate new analytical techniques and regulatory requirements.