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 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 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).
- Streamlined their previous time consuming, impractical and labour intensive quality process
- Eased compliance with GMP regulations and adherence to HTA, HFEA and MHRA
- Improved audit and incident reporting procedures
- Multiple document types – such as SOPs, policies, standards forms and agreements – managed electronically
- Reduced the need for paper documents in GMP accredited clean rooms
Working within a GMP environment, we create a lot of paper work and so had to find a way to reduce that paper work but at the same time maintain quality.Kevin Bruce, Head of Development Operations, Roslin Cells