960 x 350_41


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.


Related Thought Leaders Insights

Validation of a Stem Cell Assay Used as a Key Efficacy Marker for FDA Approval

Presented at CYTO 2024, the 37th annual Congress of the International Society for the Advancement of Cytometry, May 5-8, 2024 The recent announcement by BiolineRx of the FDA approval of APHEXDA™...

Anti-Drug Antibody (ADA) Assay for Xpro 1595, A Self-Assembling Trimer: Alternative to Standard Bridging Approach

Presented at WRIB 2024 by Jing Liu, Principle Scientist, this poster looks at the challenges posed by XPro1595, a pegylated, engineered form of soluble human Tumor Necrosis Factor alpha (TNF alpha)...

Development of a Multi-biomarker Assay for Serum Proteins by the Prognostic Lung Fibrosis Consortium (PROLIFIC)

Rules-Based Medicine, a Q2 Solutions company, was featured in a posted presented at the American Thoracic Society’s annual meeting in May 2024. The poster—Development of a Multi-biomarker Assay for...