Quality Assurance (QA)
The QA department supports research teams by developing and implementing policies and procedures to ensure quality across all stages of research. The QA objectives are focused on three main components:
- Management of Quality Documents (SOPs, policies, organizational plans, strategies and interpretation documents)
- Audit program
- Continuous quality improvement. Through a Corrective and Preventive Actions (CAPA) program, opportunities for organization-wide process improvements are identified.
QA provides direction in the creation and development of more than 100 policies and quality documents, and centrally manages their distribution and control. This includes defining the structure and format requirements, authorization and control, as well as content development.
Clinical research teams at PHRI conduct both regulated and non-regulated studies, with regulations varying between countries, even within regions. With the assistance and collaboration of our QA department, these teams ensure compliance with regularly changing regulations.
The audit function performed by QA provides independent review of specific operational areas to comply with regulatory requirements. Internal audits of all PHRI operations, vendor audits, and investigator site audits are included
In addition, the QA department supports study teams for regulatory inspection-readiness, and hosts external parties (sponsors or regulatory agencies) when they conduct audits/inspections of PHRI.