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Edinburgh-based research organisation Roslin Cells Ltd has chosen a compliance management solution from Gael Ltd to improve the efficiency and effectiveness of the company’s internal document management system. Current European and US regulatory bodies including the Human Fertilisation and Embryology Authority (HFEA), Human Tissue Authority (HTA), Medicines and Healthcare products Regulatory Agency (MHRA) and US Food & Drug Agency (FDA), require effective Document Control and Corrective/Preventive Action Management for organisations to achieve compliance. Established in 2006 by the international research centre, Roslin Institute, Roslin Cells is a leader in delivering clinical grade human stem cells for research and therapy – their requirement for an efficient Quality Management System (QMS) was crucial to meet these regulatory requirements. The award-winning compliance management solution from Gael, Q-Pulse, will help the company establish a framework to maintain and improve how defined quality processes and procedures are managed. In compliance with EU Good Manufacturing Practice (GMP), Q-Pulse will also help maintain a document management system for GMP documents including Standard Operating Procedures (SOPs) and Validation Documentation. Kevin Bruce, Quality Manager at Roslin Cells said: ‘Q-Pulse will be of substantial help to us in managing our regulated actions and activities in line with key regulations within the stem cell sector. ‘An extremely important part of these regulations is documentation, and every aspect of our processes, activities and operations must be documented. Managing these requirements with an electronic system such as Q-Pulse is invaluable for us, whilst also helping us maintain and improve both our procedures and the processes on which they are built – Q-Pulse will ensure Roslin Cells consistently maintains compliance with existing and evolving regulatory expectations.’ For further information please contact:
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