As world leaders in delivering clinical grade stem cells for research and therapy, Edinburgh-based Roslin Cells required an electronic quality management system (QMS) to help them successfully manage their
Document Control processes, SOPs and CA/PAs.

Roslin Cells currently collaborate with Universities, Blood Transfusion Services and private companies, working on projects ranging from the development of new cell therapies, to the development of new technologies. Roslin Cells expect to play a pivotal role in the regenerative medicine sector in coming years.

The Challenge

Roslin Cells had previously been using a paper-based system to manage their quality processes. Due to expansion and prospective growth, it was quickly realised that their previous methods were going to be time consuming, unpractical and extremely labour intensive. They were also under pressure to continue to conform to strict regulations – including GMPs - set out by bodies such as the Human Tissue Authority (HTA), Human Fertilisation and Embryology Authority (HFEA) and Medicines and Healthcare products Regulatory Agency (MHRA).

Kevin Bruce, Quality Manager at Roslin Cells, said: “Working within a GMP environment, we were creating a lot of paper work and so had to find a way to reduce that paper work but at the same time maintain quality. Roslin Cells has grown over the last few years and this has meant an increase in requirements for generating documents which must be administered, controlled and distributed amongst staff. We needed to find a solution which retained this control but reduced the labour involved with the administration. Additionally, as we operate a GMP clean room facility, we are always looking at ways to improve our environmental controls.”

The Solution

Q-Pulse, an electronic Quality Management Solution (eQMS) developed by Gael Ltd, was chosen by the company to help them ease the pains of working to their previous methods. Q-Pulse has helped streamline and manage their quality processes, ensuring compliance with GMP regulations and adherence to HTA, HFEA and MHRA regulatory bodies.

Kevin said: “We were aware of the fact that Q-Pulse had been successfully implemented in other regulated sectors including healthcare and aviation. We also examined Gael Ltd and Q-Pulse through our Quality Assurance and validation procedures to check that both the company and the product would meet our needs - both customer service and regulatory – over the anticipated life cycle of the product. These things together provided us with confidence that Q-Pulse would be a suitable solution for ourselves.

“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.”

The Result

Kevin added: “Q-Pulse is a user friendly electronic QMS solution which is suitable for use in regulated environments. It has increased awareness and engagement from staff with documents in terms of their awareness, ability to review, update and control their documents. The ability to access multiple pieces of information in one place should mean staff are better prepared to carry out their duties efficiently.”

Kevin continued: “We currently use Q-Pulse to manage multiple document types such as Standard Operating Procedures (SOPs), policies, standard forms and agreements. We also utilise the Assets module to manage our equipment inventory and plan/schedule and re-qualification. Internal and external inspections are critical to our activities, and the Q-Pulse Audit module helps us manage these activities and link any subsequent actions to the CA/PA module. This in itself will help manage our change control and quality related incident reporting procedures. Finally we use the Suppliers module to manage our suppliers
and their approval status. As we operate a GMP clean room facility, Q-Pulse allowed us to have controlled access to approved procedures in the clean rooms electronically, and so reduced the need for paper ocuments in the facility.

“I would thoroughly recommend the solution for use at other companies working to GMP standards.”