Navigating the complex regulatory landscape can be tricky for life science organisations. Compliance with standards set out by regulatory bodies including Medicines and Healthcare Products Regulatory Agency (MHRA), the US Department of Food and Drug Administration (FDA), and the European Medicines Agency (EMEA) require robust processes, management and systems.
A strong Quality System protects patients while driving operational excellence. Regulators have long recognised the importance of a quality culture and an effective quality management system which assures a state of control, upholds regulatory compliance and drives improvement.
Q-Pulse is a quality management system which is used by hundreds of life science organisations worldwide to meet international standards and regulations, including ISO 13485, GxP, ISO 9001 and FDA 21 CFR Part 11.
Q-Pulse not only supports organisations in their compliance processes and management but provides tangible business insights and improvement opportunities for sustained commercial success.