Quality Assurance & Training
Symyoo operates an independent Quality Assurance & Training (QA & Training) team to ensure the successful delivery of Symyoo’s quality clinical operation and outcomes.
Symyoo QA & Training team organizes and provides the continuous internal/ external trainings for all Symyoo employees to be fully qualified for their roles and responsibilities in clinical studies.
The team also provides guidance and key inputs to clinical study teams for consultation and interpretation of regulations, guidelines, internal SOPs and policies to be compliant with ICH-GCP, regulations, internal SOPs, ISO14155 and other applicable guidelines.
Symyoo’s Quality Management System (QMS) comprises our mechanisms for ensuring that all our services are performed at the highest level of ethical standards, while satisfying the relevant regulatory requirements and contractual obligations.
CLINICAL QUALITY ASSURANCE &
- Standard Operation Procedures (SOPs) and Working Document Management
- Training and Preparation of Authority Inspection and Sponsor/ External Audit
- Internal Audits: Project Audit, Process Audit, Vendor Audit, For-cause Audit
- Implementation and Management of Corrective and Preventive Actions (CAPA)
- Employee Training Program Management: Newcomer/ Advanced Training Courses, GCP, etc.
- Training Materials Development and Delivery
- Site Monitoring Quality Control: Site Co-visit
- Clinical Computer System Validation Oversight
- Vendor Qualification and Management