Quality-by-Design (QbD) is a modern approach to impurity control supported by pharmaceutical industry regulators. Pharmaceutical development groups need support from their informatics infrastructure to implement this strategy. Effective leveraging of QbD in risk mitigation requires an informatics platform that does not rely on data abstraction, simplifies data assembly, and reduces the need for human data preparation.
Luminata is CMC decision support software for impurity control that enables users to construct ‘process maps.’ The platform allows the user to visualize a range of analytical data, including spectroscopic and chromatographic data, in a single environment. These are organized by stage and substance, allowing for efficient and informed decision-making.
Learn How Luminata Supports Impurity Control:
- Easily input synthetic and visually track impurities using the process map
- Access all the relevant analytical data from within the software
- Compare the performance of impurity control strategies