Quality Control and Assurance
The Quality Group at WEP is essential for maintaining the integrity, compliance, and efficiency of the clinical trials we manage. By managing Quality Control (QC) and Quality Assurance (QA) activities, they ensure trials meet regulatory standards, minimize risks, and improve overall data quality. Their role directly contributes to trial success, regulatory approval, and the advancement of new medical treatments.
Key Quality Control and Quality Assurance Services at WEP include the following:
Risk-Based Quality Management (RBQM)
- Identification of high-risk areas for focused quality control.
- Proactive issue detection and corrective action planning.
SOP Compliance & Audit Readiness
- Strict adherence to Standard Operating Procedures (SOPs) and global regulatory guidelines.
- Regular internal audits and inspection readiness training.
- Comprehensive Corrective and Preventive Actions (CAPA) plans.
Regulatory & Ethical Compliance
- GCP, ICH, FDA, EMA, and local regulatory adherence.
- Ethics Committee (EC) and Institutional Review Board (IRB) coordination.
- Continuous regulatory updates and compliance tracking.