Quality Management System - Resources

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href='/en/Public/Services/Next-Generation-Sequencing/RNA-Seq' style='color:#585F69;font-size:14px'>RNA-Seq</a></li><li><a href='/en/Public/Services/Next-Generation-Sequencing/Proteomics' style='color:#585F69;font-size:14px'>Proteomics</a></li><li><a href='/en/Public/Services/Next-Generation-Sequencing/High-Throughput-Gene-Expression-Screening' style='color:#585F69;font-size:14px'>High-Throughput Gene Expression Screening <sup style="color:#826ec3; font-weight: bold;">NEW</sup></a></li><li><a href='/en/Public/Services/Next-Generation-Sequencing/Single-Cell-Sequencing' style='color:#585F69;font-size:14px'>Single-Cell Sequencing</a></li><li><a href='/en/Public/Services/Next-Generation-Sequencing/Exome-Sequencing' style='color:#585F69;font-size:14px'>Exome Sequencing</a></li><li><a href='/en/Public/Services/Next-Generation-Sequencing/Amplicon-Sequencing-Services' style='color:#585F69;font-size:14px'>Amplicon Sequencing Services</a></li><li><a href='/en/Public/Services/Next-Generation-Sequencing/Standalone-NGS-Solutions' style='color:#585F69;font-size:14px'>Sequencing Only<br></a></li><li><a href='/en/Public/Services/Next-Generation-Sequencing/Whole-Genome-Sequencing' style='color:#585F69;font-size:14px'>Whole Genome Sequencing</a></li><li><a href='/en/Public/Services/Next-Generation-Sequencing/High-Throughput-Genotyping' style='color:#585F69;font-size:14px'>CRISPR Validation</a></li><li><a href='/en/Public/Services/Next-Generation-Sequencing/Targeted-Resequencing-Panels' style='color:#585F69;font-size:14px'>Targeted Sequencing</a></li><li><a href='/en/Public/Services/Next-Generation-Sequencing/Metagenomics-Solutions' style='color:#585F69;font-size:14px'>Metagenomics </a></li><li><a href='/en/Public/Services/Next-Generation-Sequencing/Epigenomics' style='color:#585F69;font-size:14px'>Epigenomics</a></li><li><a href='/en/Public/Services/Next-Generation-Sequencing/Antibody-Discovery' style='color:#585F69;font-size:14px'>Antibody Discovery <sup style="color:#826ec3; font-weight: bold;">NEW</sup></a></li><li><a href='/en/Public/Services/Next-Generation-Sequencing/Immunogenomics' style='color:#585F69;font-size:14px'>Immunogenomics</a></li><li><a href='/en/Public/Services/Next-Generation-Sequencing/Digital-Spatial-Profiling' style='color:#585F69;font-size:14px'>Digital Spatial Profiling</a></li><li><a href='/en/Public/Services/Next-Generation-Sequencing/AAV-Genome-Sequencing' style='color:#585F69;font-size:14px'>AAV Genome Sequencing</a></li><li><a href='/en/Public/Services/Next-Generation-Sequencing/Whole-Plasmid-Sequencing-Plasmid-EZ' style='color:#585F69;font-size:14px'>Whole Plasmid Sequencing: Plasmid-EZ <sup style="color:#826ec3; font-weight: bold;">NEW</sup></a></li></ul></div><div class='col-md-3 '><ul class='list-unstyled'><li><a class='GColor' href='/en/Public/Services/Sanger-Sequencing' style='color:#826ec3;font-size:17px'>Sanger Sequencing</a></li><li><a href='/en/Public/Services/Sanger-Sequencing/Sanger-EZ' style='color:#585F69;font-size:14px'>Sanger-EZ <sup style="color:#826ec3; font-weight: bold;">NEW</sup></a></li><li><a href='/en/Public/Services/Sanger-Sequencing/AAV-ITR' style='color:#585F69;font-size:14px'>AAV-ITR Sanger Sequencing</a></li><li><a href='/en/Public/Services/Sanger-Sequencing/Purified-Templates' style='color:#585F69;font-size:14px'>Purified Templates</a></li><li><a href='/en/Public/Services/Sanger-Sequencing/Difficult-Template-Sequencing' style='color:#585F69;font-size:14px'>Difficult Template Sequencing</a></li><li><a href='/en/Public/Services/Sanger-Sequencing/Direct-Colony-Sequencing' style='color:#585F69;font-size:14px'>Direct Colony Sequencing</a></li><li><a href='/en/Public/Services/Sanger-Sequencing/PCR-Purification' style='color:#585F69;font-size:14px'>PCR Purification</a></li><li><a href='/en/Public/Services/Sanger-Sequencing/Primer-Walking' style='color:#585F69;font-size:14px'>Primer Walking</a></li><br><li><a class='GColor' href='/en/Public/Services/Molecular-Genetics' style='color:#826ec3;font-size:17px'>PCR + Sanger Services</a></li><li><a href='/en/Public/Services/Molecular-Genetics/Bacterial-and-Fungal-Identification' style='color:#585F69;font-size:14px'>Bacterial and Fungal Identification</a></li><li><a href='/en/Public/Services/Molecular-Genetics/Mutation-Analysis' style='color:#585F69;font-size:14px'>Mutation Analysis</a></li><li><a href='/en/Public/Services/Molecular-Genetics/SNP-Genotyping' style='color:#585F69;font-size:14px'>SNP Genotyping</a></li><li><a href='/en/Public/Services/Molecular-Genetics/PCR-Plus-Sequencing-CRISPR-Analysis-Package' style='color:#585F69;font-size:14px'>PCR Plus Sequencing CRISPR Analysis Package</a></li><li><a href='/en/Public/Services/Molecular-Genetics/cDNA-Verification' style='color:#585F69;font-size:14px'>Confirmatory Sequencing & Cell Bank Characterization</a></li><li><a href='/en/Public/Services/Molecular-Genetics/Yeast-Colony-Sequencing' style='color:#585F69;font-size:14px'>Yeast Colony Sequencing</a></li><li><a href='/en/Public/Services/Molecular-Genetics/Fragment-Analysis' style='color:#585F69;font-size:14px'>Fragment Analysis</a></li><li><a href='/en/Public/Services/Molecular-Genetics/PCR-Solutions' style='color:#585F69;font-size:14px'>Quantitative PCR & Digital PCR <sup style="color:#826ec3;"><strong>NEW </strong></sup></a></li><li><a href='/en/Public/Services/Molecular-Genetics/Nucleic-Acid-Extraction' style='color:#585F69;font-size:14px'>Nucleic Acid Extraction</a></li></ul></div><div class='col-md-3 '><ul class='list-unstyled'><li><a class='GColor' href='/en/Public/Services/Gene-Synthesis' style='color:#826ec3;font-size:17px'>DNA & RNA Synthesis</a></li><li><a href='/en/Public/Services/Gene-Synthesis/Gene-Synthesis' style='color:#585F69;font-size:14px'>Gene Synthesis</a></li><li><a href='/en/Public/Services/Gene-Synthesis/Antibody-DNA-Synthesis' style='color:#585F69;font-size:14px'>Antibody Synthesis</a></li><li><a href='/en/Public/Services/Gene-Synthesis/AAV-Plasmid-Synthesis' style='color:#585F69;font-size:14px'>AAV Plasmid Synthesis</a></li><li><a href='/en/Public/Services/Gene-Synthesis/Gene-Fragments' style='color:#585F69;font-size:14px'>Gene Fragments</a></li><li><a href='/en/Public/Services/Gene-Synthesis/CRISPR-Construct-Synthesis' style='color:#585F69;font-size:14px'>CRISPR Construct Synthesis</a></li><li><a href='/en/Public/Services/Gene-Synthesis/Synthetic-DNA-Libraries' style='color:#585F69;font-size:14px'>Synthetic DNA Libraries</a></li><li><a href='/en/Public/Services/Gene-Synthesis/Single-Stranded-DNA-Synthesis' style='color:#585F69;font-size:14px'>ssDNA Synthesis</a></li><li><a href='/en/Public/Services/Gene-Synthesis/DNA-Cloning' style='color:#585F69;font-size:14px'>DNA Cloning</a></li><li><a href='/en/Public/Services/Gene-Synthesis/Site-Directed-Mutagenesis' style='color:#585F69;font-size:14px'>Site-Directed Mutagenesis<br></a></li><li><a href='/en/Public/Services/Gene-Synthesis/Viral-Package' style='color:#585F69;font-size:14px'>Viral Packaging <sup style="color:#826ec3;"><strong>NEW </strong></sup></a></li><li><a href='/en/Public/Services/Gene-Synthesis/Recombinant-Antibody-Production' style='color:#585F69;font-size:14px'>Recombinant Antibody Production <sup style="color:#826ec3;"><strong>NEW </strong></sup></a></li><li><a href='/en/Public/Services/Gene-Synthesis/Custom-mRNA-Synthesis' style='color:#585F69;font-size:14px'>Custom mRNA Synthesis <sup style="color:#826ec3; font-weight: bold;">NEW</sup></a></li><br><li><a class='GColor' href='/en/Public/Services/Oligo' style='color:#826ec3;font-size:17px'>Oligo Synthesis Services</a></li><li><a href='/en/Public/Services/Oligo/Overnight-DNA-Oligos' style='color:#585F69;font-size:14px'>Overnight DNA Oligos</a></li><li><a href='/en/Public/Services/Oligo/Custom-DNA-and-RNA-Oligos' style='color:#585F69;font-size:14px'>Custom DNA and RNA Oligos</a></li><li><a href='/en/Public/Services/Oligo/Oligo-Retained-for-Sanger-Sequencing' style='color:#585F69;font-size:14px'>Oligo Retained for Sanger Sequencing</a></li></ul></div><div class='col-md-3 '><ul class='list-unstyled'><li><a class='GColor' href='/en/Public/Services/Plasmid-DNA-Prep' style='color:#826ec3;font-size:17px'>Plasmid DNA Preparation</a></li><li><a href='/en/Public/Services/Plasmid-DNA-Prep/Standard' style='color:#585F69;font-size:14px'>Standard Plasmid DNA Prep</a></li><li><a href='/en/Public/Services/Plasmid-DNA-Prep/Targeted-Yield' style='color:#585F69;font-size:14px'>Targeted Yield Plasmid DNA Prep</a></li><li><a href='/en/Public/Services/Plasmid-DNA-Prep/AAV-Plasmid-Preparation' style='color:#585F69;font-size:14px'>AAV Plasmid Preparation</a></li><br><li><a class='GColor' href='/en/Public/Services/Clinical-Services' style='color:#826ec3;font-size:17px'>PreClinical and Clinical Services</a></li><li><a href='/en/Public/Services/Clinical-Services/Clinical-Services-Overview' style='color:#585F69;font-size:14px'>Clinical Services</a></li><li><a href='/en/Public/Services/Clinical-Services/Microarray-Solutions' style='color:#585F69;font-size:14px'>Microarray Solutions <sup style="color:#826ec3; font-weight: bold;">NEW</sup></a></li><li><a href='/en/Public/Services/Clinical-Services/CLIA-Variant-Confirmation' style='color:#585F69;font-size:14px'>CLIA Variant Confirmation (PCR + Sanger)</a></li><li><a href='/en/Public/Services/Clinical-Services/CLIA-Sanger-Sequencing' style='color:#585F69;font-size:14px'>CLIA Sanger Sequencing</a></li><li><a href='/en/Public/Services/Clinical-Services/CLIA-Whole-Exome-Sequencing' style='color:#585F69;font-size:14px'>CLIA Whole Exome Sequencing</a></li><li><a href='/en/Public/Services/Clinical-Services/CLIA-Whole-Genome-Sequencing' style='color:#585F69;font-size:14px'>CLIA Whole Genome Sequencing</a></li><li><a href='/en/Public/Services/Clinical-Services/Regulatory' style='color:#585F69;font-size:14px'>GLP-Compliant Overview</a></li><li><a href='/en/Public/Services/Clinical-Services/GLP-compliant-Confirmatory-Sequencing' style='color:#585F69;font-size:14px'>GLP Confirmatory Sequencing</a></li><li><a href='/en/Public/Services/Clinical-Services/GLP-compliant-SNP-Mutation-Analysis' style='color:#585F69;font-size:14px'>GLP SNP Mutation Analysis</a></li><li><a href='/en/Public/Services/Clinical-Services/GLP-compliant-Plasmid-Prep' style='color:#585F69;font-size:14px'>GLP Plasmid Prep</a></li><li><a href='/en/Public/Services/Clinical-Services/Nucleic-Acid-Extraction' style='color:#585F69;font-size:14px'>GLP Nucleic Acid Extraction</a></li><li><a href='/en/Public/Services/Clinical-Services/Biofluid-Processing-Overview' style='color:#585F69;font-size:14px'>Biofluid Processing</a></li><li><a href='/en/Public/Services/Clinical-Services/CLIA-Integration-Site-Analysis' style='color:#585F69;font-size:14px'>CLIA Integration Site Analysis <sup style="color:#826ec3; font-weight: bold;">NEW</sup></a></li></ul></div></div></div></li></ul></li><li class='dropdown'><a href='/en/Public/Research-Areas' data-toggle='dropdown' class='dropdown-toggle' style='color:white;height:52px;top:47px;padding-top:0;background-color:transparent;font-size:17px;font-weight:bold;'>RESEARCH AREAS</a><ul class='dropdown-menu'><li class='dropdown'><a class='GColor' href='/en/Public/Research-Areas/AAV' style='font-size:17px'>AAV Services</a><ul class='dropdown-menu'></ul></li><li class='dropdown'><a class='GColor' href='/en/Public/Research-Areas/Agriculture-Food-Science' style='font-size:17px'>Agriculture and Food Science</a><ul class='dropdown-menu'></ul></li><li class='dropdown'><a class='GColor' href='https://web.azenta.com/cell-and-gene-therapy' style='font-size:17px'>Cell and Gene Therapy Solutions 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CLIA Integration Site Analysis <sup style="color:#826ec3; font-weight: bold;">NEW</sup> </div> </div> </div> </div> </div> </li> </ul> </li> </ul> </div> </div> </div> </div>  </div>  <br /><br /> <div class="headline-center Rich-Text-Edit-Area"> <br /> <br /> <div class="container text-left Component-BackGround-Default"> <h2 class="text-center">GENEWIZ Quality Management System</h2> <p>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.</p> <p>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.</p> <p>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: </p> <ul> <li>CLIA-compliant services in accordance with Clinical Laboratory Improvement Amendments (CLIA) 42CFR, Part 493 and College of American Pathologists (CAP) standards</li> <li> 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: <ul> <li>FDA 21CFR, Part 210</li> <li>FDA 21CFR, Part 211</li> <li>FDA 21CFR, Part 820</li> </ul> </li> <li>GCP-compliant (as applicable) services in accordance with FDA 21CFR Part 11 and 58 as well as adherence to the guidelines mentioned by the <a rel="noopener noreferrer" rel="noopener noreferrer" href="https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/reflection-paper-laboratories-perform-analysis-evaluation-clinical-trial-samples_en.pdf" target="_blank" style="color: #826ec3;">European Medicines Agency (EMA)</a></li> <li>GMP-compliant (as applicable) services in accordance with FDA 21CFR 211.180(e) </li> </ul> <p>Our regulatory services lab at our South Plainfield, NJ headquarters is CLIA-licensed and CAP-accredited.</p> <p> </p> <p>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:</p> <p class="text-center"><a href="mailto:quality@genewiz.com" class="btn-u btn-u-lg rounded btn-u-purple">Click here</a></p> <p> <br /> <br /> </p> </div> </div> <script type="text/javascript" src="/assets/plugins/counter/jquery.counterup.min.js"></script> <div class="whiteBg bg-image-v1 parallaxBg headline-center Parallax-Block-2"> <div class="container"> <div class="col-md-4"><h3>Quality by Design</h3> <ul class="list-unstyled lists-v1 text-left"> <li>GLP and CLIA regulatory-compliant laboratory with adherence to GCP guidelines</li> <li>Regulatory compliance and SOP education</li> <li>Method and Assay Validation procedures</li> <li>Custom Study Protocol Preparation and Reporting for your specific project requirements</li> <li>Vendor Qualification Program ensures all vendors meet GENEWIZ Quality System standards of excellence</li> </ul> <br /> <br /></div> <div class="col-md-4"><h3>Quality by Infrastructure</h3> <ul class="list-unstyled 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