Cardiff University Quality Assurance

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Cardiff University Quality Assurance

Quality assurance and regulatory affairs

To meet regulatory expectations and ensure best practice, we have quality systems with specific standards for each trial and study process.

Regulatory framework

Our quality management system includes:

  • personnel roles and responsibilities
  • training, policies and procedures
  • risk management
  • quality assurance and auditing
  • document management
  • record retention and reporting
  • Corrective And Preventive Actions (CAPA)
  • a procedure for investigating suspected fraud and misconduct.
Electronic quality management system (Q-Pulse)

We use Q-Pulse to effectively manage the Centre-wide quality management system. Q-Pulse is an electronic quality management system that helps organisations manage quality, safety and risk effectively. It provides employees with a central focal point for all compliance data, materials and activities. In addition, Q-Pulse makes management aware of areas in need of attention to ensure ongoing and current compliance status.

Q-Pulse provides a suite of integrated modules to manage business functions effectively and efficiently including:

  • document control
  • issues and CAPAs
  • audits and findings
  • mandatory reporting system
  • staff competency and development
  • other specialised modules, including asset, customer and supplier management.

We have a qualified and responsible management team to provide governance for the whole study process.

We are committed to staff education, learning and development. Our aspiration is to help each other to be the best and to do our best, recognising the different needs and aspirations of every individual. We help and support staff to manage their own learning so that they maximise their potential, develop their skills, improve their performance and contribute to the knowledge and performance of their teams.

Audit

Our audit programme is determined by applying the principles of quality risk management.

Our Internal Audit Group meets at least biennially to monitor and review the audit function in terms of independence, objectivity and effectiveness of internal audit. The Audit Group recommends the audit programme based on the level of risk.

Independence

Audit is performed by individuals independent of those conducting the activity i.e. not involved in the day to day activities and/or separate line management. Our auditor performs audits which are designed to determine whether the quality control (QC) activities have been implemented effectively, and to assure management of compliance with the principles of good practice. Audit involves review of a sample of data to test the system.