GENEWIZ Quality Management System

The GENEWIZ Regulatory Quality Management System ensures GLP, GCP and CLIA compliance throughout our preclinical and clinical projects. Quality oversight confirms strict FDA and EPA regulatory adherence for our regulatory services customers and consistency in all of your data.

As a trusted partner for research advancements and product development, we constantly strive to meet the needs and expectations of our customers. Our philosophy is to ensure that quality is built into all aspects of our regulatory services.

The Quality Management System for regulatory services is designed in accordance with CAP standards, FDA, EPA Code of Federal Regulations (CFR), and guidelines under European Medicines Agency (EMA). Our offers:

  • CLIA-compliant services in accordance with Clinical Laboratory Improvement Amendments (CLIA) 42CFR, Part 493 and College of American Pathologists (CAP) standards
  • GLP-compliant services in accordance with Good Laboratory Practice (GLP) for both FDA 21CFR, Part 58 as well as EPA 40CFR, Part 160. Our GLP services are compliant with select relevant sections of:
    • FDA 21CFR, Part 210
    • FDA 21CFR, Part 211
    • FDA 21CFR, Part 820
  • GCP-compliant (as applicable) services in accordance with FDA 21CFR Part 11 and 58 as well as adherence to the guidelines mentioned by the European Medicines Agency (EMA)
  • GMP-compliant (as applicable) services in accordance with FDA 21CFR 211.180(e)

Our regulatory services lab at our South Plainfield, NJ headquarters is CLIA-licensed and CAP-accredited.


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. To request an audit for regulatory services:

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Quality by Design

  • GLP and CLIA regulatory-compliant laboratory with adherence to GCP guidelines
  • 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 GLP and CLIA compliant laboratory with adherence to GCP guidelines
  • Instrument Qualification (IQ/OQ/PQ) Program for key equipment used for regulatory services
  • On-site restricted access document archive with fireproof storage
  • Electronic data back-up and 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
  • Quality management is overseen by an independent quality assurance department