Quality Assurance
Comprehensive quality management and compliance oversight throughout the clinical development lifecycle.
Implementation of the Quality Management System
- QMS framework development:
Quality policy establishment and organizational structure design - Documentation system:
SOPs, work instructions, and quality manual creation
- QMS framework development:
Inspection readiness
- Regulatory preparation:
Documentation review and compliance gap analysis - Mock inspections:
Internal audit simulations and readiness assessments - Staff training:
Inspection procedures and regulatory interaction preparation - Documentation organization:
File preparation and regulatory submission readiness
- Regulatory preparation:
Audits / MOC inspections
- Internal audits:
Systematic quality assessments and compliance verification - MOC inspections:
Support and coordination during Management of Change-related regulatory inspections - Audit follow-up:
Finding resolution, CAPA implementation, and corrective action tracking
- Internal audits:
Regular Quality Control
- Ongoing monitoring:
Continuous compliance assessment and process evaluation - Quality metrics:
KPI tracking and performance indicator analysis - Risk management:
Quality risk identification and mitigation strategies - Corrective actions:
Non-conformance management and preventive measure implementation
- Ongoing monitoring:
