Quality Management System
Everest’s Quality Management System supports project teams to collaborate with pharmaceutical, biotechnology, and medical device companies in developing and commercializing their products with high quality and cost-effectiveness.
Everest’s Quality Management System consists of 6 major components, which have been identified through our experience as a Contract Research Organization (CRO) as the most fundamental and key elements for success. We have become and continue to develop as a center of excellence in clinical research by maintaining our sound operating principles, quality and customer-focused approach, strong culture and values, benchmarking and continuous improvement, fact-based method for decision making, and a process- and system-approach to management.
Clinical research services performed at Everest are governed by policies, controlled processes, and standard operating procedures that are compliant with laws, regulatory requirements, and industry standards.
These governing documents form the foundation for Everest's success:
- Code of Conduct
- Quality Management System Manual
- Process Maps
- Standard Operating Procedures (SOPs)
- Working Instructions, including QC/QA Checklists
- Training Materials
Everest believes that good practices and a process-driven approach are beneficial to achieving high quality, shorter timelines, lower costs, and consistent and predictable results.
Quality and Compliance Focus
Our Quality Assurance and Compliance independent oversight is based on the requirements as specified in the Everest Quality Management System Manual and includes the following responsibilities:
- Control and maintain Everest's corporate governing documents.
- Monitor and audit adherence to policies, controlled processes, and standard operating procedures; follow up on all adherence issues through to resolution.
- Monitor and assess compliance to defined mandatory training requirements.
- Plan and perform internal audits, follow up on audit findings until resolved.
- Prepare for and coordinate client and regulatory agency audits, follow up on audit findings until resolved.
- Perform vendor audits, follow up on audit findings until resolved.
- Plan and lead teams to perform Corrective and Preventive Action (CAPA).