AAV Gene Therapy
R&D quality management system on global level
An independent Quality Assurance unit is strongly in operation, inspecting and assuring our research quality system to comply with the global standards. Our QA unit carries out internal audits routinely on data integrity including lab notebook, equipment use, preventive maintenance log, and employee training files, etc. We also go through supplier qualification assessment for the external contract service providers to ensure their work-quality system to perform our outsourced studies.
SOPs
Developing and
managing SOPs
- Study process managing system
- Routine inspection
Document
Control
Documentation and
amendment control
- Protocol
- Report
- Test Methods
- SOPs
Quality Record
& Archiving
Record retention
Internal compliance
- Laboratory notebook
- Test data
- Training records
- Equipment use/PM log
- QA audit records
Internal Audit
Independent
QA unit
- Independent QA team inspecting
- employee training records
- lab notebook
- equipment use log
- research process, etc
CSP Audit
CSP Quality
Management
- QA audit on service providers including GxP
SOP : Standard Operating Procedure
CSP : Contract Service Provider