Quality is at the heart of all activities within Colibri Scientific and is assured through our internal Quality Management System which is audited by an independent QA inspector. Our QMS is compliant with the ICH Harmonised Tripartite Guideline for Good Clinical Practice (GCP), the MHRA guidance for Good Clinical Practices Laboratories and the FDA principles for quality systems.
Detailed standard operating procedures (SOPs) governing all critical paths are in effect. All staff have documented training records and curriculum vitaes demonstrating training received, qualifications, education and work experience. All record keeping practices are fully compliant with GCP and our Laboratory Information Management System complies with FDA 21 CFR Part 11.
- Sample tracking/chain of custody throughout sample lifetime
- Sample logistics
- Clinical kit production and distribution
- Laboratory manual writing
- Site training – investigator meeting or on site
- Project management
- Short and long term storage via our specialist partner