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Located at Cardiff University’s School of Medicine on the site it shares with the University Hospital of Wales Cardiff, the Wales Research & Diagnostic Positron & Emission Tomography (PET) Imaging Centre has chosen a compliance management solution from Gael Ltd to improve the efficiency and effectiveness of the company’s internal Document and Audit Management system. A partnership project between Cardiff University and Cardiff & Vale NHS Trust, the Centre will be the first of its type in Wales. It will provide the focus for cutting edge research and teaching in PET for a network of higher education institutions across Wales and the UK, as well as delivering a local clinical service for NHS Wales patients. The Imaging Centre’s requirement for an efficient Quality Management System (QMS) is crucial to help them prepare for a license from the Medicines and Healthcare products Regulatory Agency (MHRA). Current European regulatory bodies including the MHRA, require effective Document Control, Audit Management, and Corrective/Preventive Action Management, for organisations to achieve compliance. The award winning compliance management solution from Gael, Q-Pulse, will help the Centre establish a framework to maintain and improve how defined quality processes and procedures are managed, helping them achieve and maintain compliance with EU Good Manufacturing Practice (GMP). Ian Davies, Technical Director at the Wales Research & Diagnostic PET Imaging Centre said: ‘Q-Pulse will be of substantial help to us in managing our regulated actions and activities in line with EU GMP requirements. An extremely important part of EU GMP regulations is documentation: we will be inspected by the MHRA and every aspect of our processes, activities, and operations must be documented. ‘Managing the requirements of EU GMP with an electronic system such as Q-Pulse will also assist us in maintaining and improving both our procedures and the processes on which they are built - Q-Pulse will help ensure the Wales Research & Diagnostic Positron PET Imaging Centre consistently maintains compliance with existing and evolving regulatory expectations.’ For further information please contact:
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