Quality Assurance is a key component of our commitment to providing our customers with high-quality services. The objective of the Quality Assurance department is to ensure that we meet the quality requirements and meet the regulatory requirements.
Our Quality Assurance Department ensures that the facilities, equipment, staff, methods, documents, practices, records, and controls comply with the regulations.
Our employees are involved in the implementation of our Quality Policy. They ensure that their work processes are efficient and continually improving.
GenoSafe is in compliance with the “Good Laboratory Practices” (GLP) and “Good Clinical Practices” (GCP) standards.
Focus : Quality System
- Documented change control
- Methods/assays validation as per ICH guidelines
- Internal quality audits in Routine and in-process audits
- Incident report, OOS (Out Of Specification) and CAPA program (Corrective Actions Preventive Actions)
- Accreditation program of operators
- Complete documentation of laboratory procedures
- Procedures for archiving and storing projects
- Scheduled management reviews of the quality system
- For GLP studies: QA statement reviewing a full audit process from raw data to the final report.