Cellular Therapy Regulatory Compliance

National and international quality standards and regulations including MHRA, FDA, HTA, HFEA, JACIE, ISO 9001 and GMP all require stem cell organisations to demonstrate compliance to their requirements. Using manual paper based systems to manage compliance activities is often time consuming, impractical and labour intensive. As a result, many stem cell organisations find themselves unable to manage quality and compliance effectively, and are unprepared when an internal or external audit is announced.

To help organisations improve their processes and procedures around quality and compliance, and to ensure those strict regulatory requirements and standards are met, many organisations across the stem cell sector use Q-Pulse to help them achieve and maintain regulatory compliance.

Q-Pulse, from Gael, is a fully integrated electronic Quality Management Solution that will help stem cell organisations significantly decrease the time spent on day-to-day compliance activities including; Document Control, Auditing, Corrective and Preventive Actions (CA/PA), Incident and Risk Investigations, Suppliers, Staff Competencies and Training and Assets. Q-Pulse improves the internal processes around managing these, and also helps to reduce costs and increase productivity.

Organisations such as Roslin Cells, Future Health, University of Sheffield, University of Utah and Central Manchester University Hospitals Foundation Trust, are all using Q-Pulse to help improve the management of their compliance requirements. Kevin Bruce, Quality Manager at Roslin Cells, said: "Q-Pulse makes it easier to achieve compliance with our standards and regulations, providing us with the tools to implement simpler methods and processes to manage quality…a user friendly electronic QMS solution which is suitable for use in regulated environments, I would thoroughly recommend the solution for use at other companies working to GMP standards.”

Contact us now to find out how Q-Pulse can help you efficiently and effectively manage your compliance activities.