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.’
Contact Gael now to find out how Q-Pulse can support your organisation in saving time, resources and expenditure in achieving regulatory compliance. END
Notes to Editors
Gael Ltd is a market leader in the design, development and delivery of compliance management software.
Q-Pulse from Gael Ltd is a fully integrated compliance management solution that covers key regulatory functions such as Auditing, Document Control and CA/PA Management, in compliance environments including GxP, ISO standards and 21 CFR 820.
Designed for organisations operating in strict regulatory compliance environments in the healthcare, life science and aviation marketplace, the product has been specifically developed to support the operational activities of a company’s compliance management system.
From implementing and maintaining processes and procedures, to improving and growing your management system, Q-Pulse is an all round market leading solution for Quality Management.
Contact Details
Lorna Elmslie, Online Marketing Executive, lornae@gaelquality.com
Gael Ltd, Orion House, Scottish Enterprise Technology Park, East Kilbride, G75 0RD
T: +44 (0)1355 593400
F: +44 (0)1355 579191
E: info@gaelquality.com
W: www.gaelquality.com
