QUALITY
MANAGEMENT
MANAGEMENT
Standardized Processes and Systems Audit
Our team approach to quality management begins in the implementation phase and exists within all systems and processes throughout the lifecycle of a program or clinical trial. The approach includes the incorporation of standardization through education, written procedures, the establishment of defined metrics, and auditing.
Our Quality Management Systems
We offer the following Quality Management Services:
Quality Audits
| Quality Management Plans |
| Metrics for Performance and Compliance |
| Independent Data Auditing |
| 21 CFR Part 11 Compliance |
| Standard Operating Procedures |
| Regulatory Master File Review |
| Preparation and Facilitation of Third Party Audits |
| Site GPC Audits |
| Vendor Qualification Audits |
