The quality assurance department is independent from operations and reports directly to our Managing Director. The QA personnel provides supervision and work closely with each department to ensure the same level of quality and consistency across all our central lab facilities. We continually monitor both data quality and our laboratory operations to assure that the highest standards are maintained.
We have established our Quality System on the well-recognized international quality standards and regulatory guidelines: ISO 15189:2007, ISO 17025:2005, Good Clinical Practicies (GCP), and Good Clinical Laboratory Practicies (GCLP). Additionally, our databases are compliant with the Code of Federal Regulations Title 21 Part 11 (21CFR Part11), which applies to electronic records.
We also invest significant time and resources in our employee training and operations improvement programs.
Our complete quality system includes:
- Standard Operating Procedures
- Internal Audits
- Quality Metrics Programs
- Employee Training
- Analytical Proficiency Programs
- External Independent Audits