Quality Management System
Voxtur Quality Assurance consists of highly qualified and experienced professionals.
Quality Assurance operates based on Quality Management System (QMS) comprising of mechanisms for ensuring that all our services perform to the highest ethical standards, conform to all relevant regulatory requirements and satisfy contractual obligations. The Quality Management System QMS is based on continual improvement, with ongoing measurement of process performance to determine the effectiveness of the QMS.
Quality Assurance systems and processes include review of documents, conduct of Facility (Hospital ) and study-based inspections to maintain high standards of quality and monitor studies for compliance to global regulatory requirements through well planned independent audits and reporting.
We collaborate with our clients and ensure compliance with the protocol, SOPs, and regulatory guidelines, emphasizing subject safety and data quality/integrity.
Our experienced staff offers a comprehensive Quality Assurance service programs including:
- Clinical Trial Site Audit
- Designing Study Documents Formats
- Systems and process audits
- Computer system validation documentation compliance
- Clinical study report and regulatory submission document