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Quality

Our Quality Management System (QMS), based on regulatory requirements, industry standards and best practices gives you confidence in the data we deliver

Overview of quality activities

Our QMS enables continuous organizational and process improvement by incorporating a set of coordinated activities designed to direct and control quality operations. These activities include:

  • Laboratory Quality
  • Process and Document Management
  • Data and Document Retention/Archival
  • Change Management
  • Quality Issue Management
  • Equipment and Facilities Management
  • Training and Competency Management
  • Computerized Systems
  • Vendor Management
  • Audit Management
  • Purchasing and Inventory
  • Customer Service and Customer Feedback Management

Regulatory standards

Our QMS is based upon the standards set forth in Good Clinical Practices (GCP), College of American Pathologists (CAP) and Clinical Laboratory Improvement Amendments (CLIA).

 
CAP CAP Accreditation in 2017
CLIA CLIA Certified since 2010
GCP Q2 Solutions maintains a QMS that is compliant to the applicable Good Clinical Practices for clinical and genomic testing conducted.
NYS NYS Certified in 2018

Quality Control (QC) metrics & standards

To ensure data quality, we monitor several QC metrics and incorporate controls during sample processing. These practices are required as part of our CLIA compliant programs. They are also recommended in voluntary genomic data submissions to the FDA and are recognized best practices. Our efforts promote standardization initiatives including the External RNA Control Consortium (ERCC), MicroArray Quality Control (MAQC) and Sequencing Quality Control (SEQC) Consortiums.

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