Our Quality Management System (QMS) underpins every engagement. It defines how we design SOPs, train staff, conduct internal audits, manage deviations and CAPAs, and prepare for sponsor and regulatory inspections. The result is a continuous, documented chain of quality from protocol to database lock.
A system, not a checklist
Quality at Clinitec is a system, not a checklist. Every role carries quality responsibilities, every process has an owner, and every deviation is logged, investigated, and resolved through CAPA. Our QMS is built to ICH E6(R3) expectations and is continually refined against regulator feedback and audit findings.
Inspection readiness
We maintain continuous inspection readiness. Trial Master Files are complete, QC-reviewed, and version-controlled. Personnel training records are current. Quality events are tracked to closure. Sponsors and authorities can audit at any time and find a system that holds up.
- ICH E6(R3) GCP-compliant QMS
- Continuous TMF completeness and QC
- Deviation-to-CAPA tracking with audit trail
- Sponsor and regulatory audit-ready, always
Audit history
We maintain a flawless audit history with major international health authorities, including USFDA, EMA, and national bodies — with zero critical observations to date.