960 x 350_41

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.

medical-data-on-screen

Related Thought Leaders Insights

White Paper

Ensemble-based method for detecting differential expression in RNA datasets provides greater sensitivity and less biased p-values than existing methods

In examining two-group differential analysis, it is apparent that different statistical methods can yield very different results even given the same RNA-Seq input data. In particular, we have...

White Paper

Assay development, validation, and manufacturing with built-in quality controls

With more than 25 years of experience, Rules-Based Medicine, a Q2 Solutions company develops, validates and manufactures its assays with integrity and commitment for the most reliable, reproducible...

Scientific Poster

Unleashing the power of MHC Associated Peptide Proteomics: Immunogenicity Assessment of Oncology Drugs

By Chloe Ackaert, Jana Schockaert, Aurelie Mazy, Martijn Vlaming, and Sofie PattynPresented at the American Association for Cancer Research (AACR) Annual Meeting, April 5-10, 2024 Bispecifics...