In accordance with applicable Good Laboratory Practice/ Good Clinical Laboratory Practice (GLP/GCLP) regulations and guidelines, the PGx Centre’s Quality Management System is dedicated to offering to clients and stakeholders fact-based confidence that the Centre’s services meet their needs, expectations, quality and other requirements.
The PGx Centre’s quality assurance relies on a set of policies, processes and procedures encompassing the control of documentation and changes; deviation, incident, investigation, audit, corrective and preventive action reporting; assay/method qualification and validation; computerized systems validation, and training of personnel.
Documented processes and procedures are used for all activities related to the handling, storage and analyses of biological samples and scientific data. These activities are performed by highly qualified and trained personnel.
Quality Control strives to prevent errors in sample handling, analytical, and data-related activities by performing a series of checks and controls at critical points in the process chain, from data generation, to handling and reporting. All checks are based on current GLP/GCLP requirements, and controls are chosen and established based on recognized scientific data.
Analytical equipment, instruments and laboratory support systems are managed according to current GLP/GCLP requirements for instrument calibration and preventive and emergency maintenance, in order to prevent quality issues related to equipment performance or failure.
The PGx Centre’s activities rely heavily on computerized systems for the analytical and scientific data it generates and stores. Thus, the utmost care is taken to protect and maintain the installation’s Information Technologies infrastructure and the data it contains.
Additionally, the confidential nature of some of the information gathered on patients and subjects makes access and exchange of data a critical priority of the PGx Centre. Special IT security processes have been implemented to address this.