GENEWIZ Quality Management System

Developed to support GENEWIZ operations, the GENEWIZ Quality Management System ensures quality throughout all aspects of our GLP-compliant services. For customers, the GENEWIZ Quality Management System confirms strict FDA and EPA regulatory adherence and consistency in all of your data.

GENEWIZ quality philosophy ensures that quality is built into all aspects of our services. As a trusted partner for advancing research and product development, GENEWIZ constantly strives to meet the needs and expectations of our customers.

Designed in accordance with the FDA and EPA Code of Federal Regulations (CFR), the GENEWIZ Quality System is compliant with 21CFR, Part 58 as well as 40CFR, Part 160.

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Quality by Design

  • GLP regulatory-compliant laboratories
  • Regulatory compliance and SOP education
  • Method and Assay Validation procedures
  • Custom Study Protocol Preparation and Reporting for your specific project requirements
  • Vendor Qualification Program ensures all vendors meet GENEWIZ Quality System standards of excellence

Quality by Infrastructure

  • Sample Handling and Tracking System: Controls sample check-in, processing, storage, and disposal
  • Restricted-access laboratory compliant with GLP regulations
  • Installation, Operational, and Performance Qualification (IQ/OQ/PQ) Program: Qualifies all key instruments used for GLP projects
  • On-site fire-resistant data archiving
  • Off-site data back-up storage

Quality by Assurance

  • Corrective Action/Preventative Action (CAPA) System: Identification of problem, the root cause, and continuous improvements in quality
  • Out of Specification (OOS) Investigation System: Investigation of any unexpected and/or abnormal results
  • Quality Trending System: Identification of variations or trends in data
  • Regular internal audits and management reviews