Quality Assurance
HCRI’s Quality System
A team of dedicated professionals oversees a comprehensive, enterprise-wide system designed to comply with applicable GCP regulations including 21 CFR Part 11. HCRI proactively focuses on continuous improvement to assure the highest quality research. The Quality System also prevents, detects, investigates, assesses and corrects errors and violations associated with the conduct of clinical trials.
HCRI’s Quality System requires the active involvement of all functions within the organization.
Four Elements of Our Quality System:
Capture all customer feedback
The Quality System begins with the active process of documenting all relevant customer comments and feedback.
Provide relevant and integrated training
Learning and quality go hand-in-hand. HCRI’s learning management system tracks and documents all employee training requirements. Compliance seminars include good clinical practice (GCP) training.
Connect feedback to corrective action
HCRI’s CAPA (Corrective And Preventive Action) system performs root cause analysis and assigns appropriate issue-solving steps.
Conduct internal audits
Self-policing affirms adherence to the Institute’s own SOPs. HCRI regularly conducts internal audits and data quality control reviews to support compliance with regulatory and industry standards.
