Quality Assurance & Auditing
GxP quality assurance and clinical quality auditing performed directly by our in-house quality professional.
The challenge
Quality issues are often found late, when they are hardest to correct, and risks are known but not owned. Sponsors need independent assurance that systems, partners and documentation meet GxP expectations before an inspection asks the question.
Scope of support
- GxP quality assurance
- Clinical quality auditing: audit planning and execution
- Quality system assessment
- Compliance assessment
- Inspection readiness
- Quality risk management, aligned with risk-based quality management principles
- Issue management and corrective and preventive action tracking
Key deliverables
- Audit plans and audit reports
- Quality system and compliance assessment findings
- Inspection readiness assessment
- Quality risk assessment and mitigation plan
- Issue and CAPA log
Expected operational benefits
- Quality risks with named owners and agreed responses
- Attention focused on what matters for participant safety and data integrity
- Documentation that supports inspection readiness