MindCapture can support you in setting up, improving or reorienting your Quality Management System (QMS). We initially perform an as-is analysis, make a gap analysis, followed by the set-up of a fit for purpose QMS. Our QualityCapture team includes each aspect needed to reach this, such as validation of software according to GAMP5 methodology, instruments, reagent control, methods and processes. Next, we focus on data integrity in compliance with international standards, guidelines, regulations or GxP, as well as document control, training and personnel, complaint and CAPA handling. We offer also risk management support. We go for the solution that best matches your needs, in alignment with the available time, budget and resources.