Whether it comes to dose or weigh systems, manufacturing devices, track and trace systems or electronic signatures – companies in the pharmaceutical industry can benefit from automation of their production environments. However, these automation projects always need to be validated to guarantee they comply with the industry’s strict guidelines and legislations.
QbD is the expert in validation for the pharmaceutical industry. With help of the GAMP 5 ® (ISPE) methodology – a structured and project-based way to validate automated systems – we guide you through the whole process of automation validation. It’s good to know that we always make use of a risk-based approach. In other words, we specifically focus on the aspects of your automation validation that bring along the most risks. This pragmatic, efficient way of testing and validating guarantees you spend your budget in the right way.
Interested in automation validation? We support you throughout the whole process. From writing a validation plan to the formulation of user requirements and their translation to functional and technical specifications, and testing and validating your system. Feel free to contact us.
QbD, your automation validation partner, cooperates closely with Reditech. If you’re looking for a partner for the implementation of automation projects, then Reditech is your expert, not only for the pharmaceutical industry, but also the clean tech, water, (petro) chemical and food industries.