Quality Assurance & Regulatory Compliance

Quality Assurance

The QA department supports research teams by developing and enforcing policies and procedures to ensure quality across all stages of research. Comprised of three main components, the management of Standard Operating Procedures (SOPs), an Audit Program, and Continuous Quality Improvement – through a Corrective and Preventive Actions (CAPA) program, the QA team develops and centrally manages Quality Assurance policies for all functional areas at the PHRI.

QA provides direction in the creation and development of more than 100 Policies and Standard Operating Procedures and centrally manages their distribution and control. This includes defining the structure and format requirements, authorization and control, as well as content development.

Regulatory Compliance

Clinical trial teams at Population Health Research Institute conduct both regulated and non-regulated studies, and routinely submit the necessary documentation required to conduct research in numerous countries throughout the world.

Regulations within different regions and countries vary and undergo change and evolution constantly. With the assistance and collaboration of Quality Assurance, the clinical trial teams ensure that regulatory submissions are fully compliant with these regulations.

The audit function performed by the QA department provides the independent review of specific operational areas to review compliance of regulatory requirements. The audit program includes internal audits of all PHRI operations, vendor audits and Investigator Sites. In addition, the QA department hosts external parties (sponsors or regulatory agencies) when they conduct audits of the PHRI. Our CAPA program identifies opportunities for organization-wide process improvements.