Quality

Quality Assurance is a key system to provide high-quality services to fully satisfy our customer needs and expectations. Quality assurance is focused on providing confidence that quality requirements are fulfilled.

Our quality system meets the requirements from regulatory authorities and our Quality Assurance Department ensures that the facilities, equipment, personnel, methods, documents, practices, records, and controls are in conformance with the regulations.

Our employees understand and implement our Quality policy. They are responsible for ensuring that their work processes are efficient and continually improving.

GenoSafe is a Good Laboratory Practices (GLP) and  Good Clinical Practices (GCP) compliant facility.

With our quality assurance approach, our customers can be confident that all quality requirements are fulfilled.

”Focus

  • Documented change control and review program
  • Methods/assays validation as per ICH guidelines
  • Routine internal quality audits and in-process audits
  • Incident report, OOS (Out Of Specification) and  CAPA program (Corrective Actions Preventive Actions)
  • Employees accreditation program
  • Complete documentation of laboratory procedures
  • Project archive and storage procedures
  • Scheduled management reviews of the quality system
  • For GLP studies: QA statement reviewing a full audit process from raw data to the final report.