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The University of Edinburgh has chosen Gael Ltd to support the Quality Management System (QMS) at a new Clinical Research Imaging Centre (CRIC), to help them prepare for a license from the Medicines and Healthcare products Regulatory Agency (MHRA). Established as a partnership between the University of Edinburgh's Queen's Medical Research Institute (QMRI) and the University Hospitals Division of Lothian NHS Board, the new centre will hold state-of-the art equipment to give patients access to one of the world's most advanced diagnostic facilities, increasing access and capacity to more clinical research projects. As Document Control and Audit Management are key requirements to comply with industry regulations, the award winning compliance management software from Gael - Q-Pulse, will not only improve the efficiency and effectiveness of the centre's internal document management system, but also help establish a framework to maintain and improve how quality activities are managed, enabling CRIC to obtain and maintain an MHRA license. Dr Sharon Hannah, Project Manager at CRIC said, ‘We anticipate that Q-Pulse will be of substantial help to us in managing our regulated actions and activities in line with European Union Good Manufacturing Practice (EU GMP) requirements. ‘An extremely important part of EU GMP regulations is documentation: we are inspected by the Medicines and Healthcare products Regulatory Agency (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.’ For further information please contact:
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