Quality Assurance (QA) Team
The purpose of the QA team is
- To assure that all clinical trials sample analysis and associated activities (such as method validation) are conducted in accordance with GCP, EU and UK Clinical Trials Regulations, Directives and Amendments
- To promote and support a culture of quality leading to scientific excellence within the GCP team of CEP
The Quality Assurance team are routinely involved in the following activities:
Project Activation Reviews
To ensure compliance with GCP, regulatory and contractual requirements and local CEP procedures
Document Reviews
To ensure compliance with GCP, regulatory requirements, relevant guidance and local CEP procedures
Compliance Advice
To promote and support a culture of compliance via guidance in the interpretation of GCP, regulatory and contractual requirements and local CEP procedures
Auditing
Internal auditing is conducted to confirm compliance, minimise any risks of non-compliance, identify any procedural gaps and maintain continuous improvement in a systematic way
Data Audits
To ensure the validity and accuracy of laboratory data prior to release to sponsor(s)
Non-Conformance Support
To correct the consequences of errors that have the potential to impact integrity or reliability of trial data, patient confidentiality, patient consent or patient safety and to minimise the likelihood of reoccurrence
Document Control
To ensure documents are reviewed, approved and distributed appropriately and that superseded and withdrawn/suspended documents are retained, but are secured to prevent unintended use
Archiving
To prevent unauthorised access and changes to, or loss of, retained records and materials. Access to the archive is controlled by, and restricted to, the archivist and a deputy archivist
Quality Management System (QMS) Development Projects
Current projects include the introduction of a new non-conformance process, a new change control process and assessing the impact of the new EU clinical trials regulation on the CEP QMS