Developed to support GENEWIZ operations, the GENEWIZ Quality System ensures that quality is built into all aspects of our services. For the customer, the GENEWIZ Quality System means strict regulatory adherence and consistency in all of your data.
The GENEWIZ Quality System ensures quality through initiatives in design, assurance, and infrastructure.
| Quality by Design |
- GENEWIZ GLP-compliant laboratories in New Jersey
- Regulatory compliance and SOP training
- Method and Assay Validation procedures
- Customized Test Study Protocol Preparation and Reporting to each customer’s requirements
- Vendor Qualification Program to ensure use of vendors that meet GENEWIZ Quality System standards
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| Quality by Assurance |
- GENEWIZ Out of Specification (OOS) Investigation System: primed to investigate unexpected and abnormal results
- Corrective Action/Preventive Action (CAPA) System: to identify problem root cause and continuously improve quality
- Quality Trending System: to identify variations or trends in data
- Regular internal audit and management reviews
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| Quality by Infrastructure |
- GENEWIZ Sample Handling and Tracking System: to control sample check in, processing, storage, and disposal
- Laboratory with restricted access
- Installation, Operational, and Performance Qualification (IQ/OQ/PQ) Program
for all instruments used for GLP projects
- On-site fire-resistant data archiving
- Offsite data backup storage
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