Quality

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

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).

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.