Q2 Solutions Q2 Solutions Actionable Insights for Better Health and Lab Solutions

Quality

Get the most out of your data. 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:
  • Document Management
  • Quality Issue Investigation
  • Corrective Action Preventative Action (CAPA) Management
  • Validation – Method, Equipment, and Software
  • Personnel Training and Proficiency
  • Equipment Management
  • Process Testing Records
  • Information Management: Paper and Electronic
  • Data and Document Retention/Archival
  • Deviation Management
  • Process Control
  • Process Improvements
  • Services, Purchasing and Inventory
  • Facilities and Safety
  • Customer Service and Customer Feedback Management

Regulatory standards

Our QMS is based upon the standards set forth in Good Clinical Practices (GCP), and Clinical Laboratory Improvement Amendments (CLIA).
CLIA CLIA certified under 42 CFR Part 493. The provisions of this federal requirement allows for laboratory testing of human specimens in clinical and diagnostic applications.
GCP Q2 Solutions maintains a QMS that is compliant to the applicable Good Clinical Practices for clinical and genomic testing conducted.

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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