Introduction

Roslin Cells, based in Edinburgh, collaborates with universities, blood transfusion services and private companies on projects ranging from developing new cell therapies to advancing new technologies. They play a pivotal role in the regenerative medicine sector, adhering to strict regulatory standards to ensure quality and safety. 

The challenge

  • Inefficient, paper-based quality management system
  • High volume of paperwork required for compliance with GMP, HTA, HFEA and MHRA regulations
  • Need to improve audit and incident reporting procedures

The solution

Roslin Cells selected Ideagen Quality Management for its:

  • Ability to manage various document types electronically
  • Tools for simplifying compliance with multiple regulatory standards
  • User-friendly interface suitable for regulated environments

Implementation and impact

Before, Roslin Cells struggled with managing quality processes through a paper-based system, leading to inefficiencies and compliance risks. The transition to Ideagen Quality Management provided a centralized, electronic solution that improved operational control and compliance.

This transformation enabled Roslin Cells to maintain high standards and effectively manage their quality management system:

  • Streamlined their previously time-consuming and labor-intensive quality processes
  • Improved document management by controlling and managing multiple document types electronically
  • Enhanced compliance with GMP regulations and adherence to HTA, HFEA and MHRA
  • Improved audit and incident reporting procedures, linking subsequent actions to the CA/PA module
  • Reduced the need for paper documents in GMP clean rooms, allowing controlled electronic access to approved procedures

[Ideagen Quality Management] 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.

Kevin Bruce, Head of Development Operations, Roslin Cells

Real results 

Ideagen Quality Management enhanced Roslin Cells’ quality management processes, ensuring better efficiency, control and compliance with GMP and other regulatory standards: 

Managed multiple document types electronically, including SOPs, policies, and agreements

Eased adherence to GMP regulations and compliance with HTA, HFEA and MHRA

Minimized the need for paper documents in GMP clean rooms, improving efficiency

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