Quality Systems
It is the policy of Expression Analysis to implement a Quality Management System based on regulatory requirements, industry standards and best practices. Our Quality Management System incorporates a set of coordinated activities that function to direct and control the organization with regard to quality. These activities are based on CLSI guidelines and are referred to as Quality System Essentials (QSEs). Each QSE is listed below.
- Documents and Records
- Organization and Business Operations
- Personnel
- Equipment
- Services, Purchasing and Inventory
- Process Control
- Information Management/ Paper and Electronic
- Occurrence Management
- Assessments
- Process Improvements
- Customer Service
- Facilities and Safety
- Process Testing Records
Expression Analysis has developed comprehensive and robust QSEs that standardize and coordinate a variety of activities focused on continuously improving business and operational activities while fostering a safe and rewarding work environment within the bounds of ethical behavior and regulatory requirements.
All the company’s employees participate in the QSEs. Employees are trained on applicable QSE activities related to their job responsibilities. This includes their responsibility to actively communicate to appropriate staff when they suspect nonconformance with policies and procedures or recognize an opportunity for improvement. Expression Analysis has a no-retaliation policy that provides a welcoming venue for constructive criticism and self-reporting.
Expression Analysis is compliant with Good Laboratory Practices (GLP), Good Clinical Practices (GCP), and Clinical Laboratory Improvement Amendments of 1988 (CLIA).
GLP
In 2004, Expression Analysis became the first company capable of providing gene expression services with microarrays in compliance with Good Laboratory Practices, 21 CFR Part 58. We maintain a robust quality system to support these regulations, including detailed SOPs, equipment and process validations, training, audits and document control measures.
CLIA
Expression Analysis is 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
Expression Analysis adheres to any applicable guidance on good clinical practice and the conduct of clinical trials.
Quality Control (QC) Metrics & Standards
To ensure data quality, Expression Analysis monitors several QC metrics and incorporates nucleic acid standards during sample processing. These practices are required as part of our GLP and CLIA compliant programs. They are also recommended in voluntary genomic data submissions to the FDA. Our efforts promote standardization initiatives for microarray quality, including the ERCC and MAQC.
Proficiency Testing for Microarray Labs
Expression Analysis developed the first Proficiency Testing Program for microarray laboratories. Such inter-laboratory comparisons are required as part of CLIA compliant system and support the goals of the FDA-led Microarray Quality Control Project.
Links:
CLMA – Clinical Laboratory Management Association
CLIA – Clinical Laboratory Improvement Amendments
CLSI – Clinical and Laboratory Standards Institute