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QUALITY

 

Expression Analysis has developed comprehensive and robust quality procedures.  The main component of is a Quality System Program (QSP) that standardizes and coordinates a variety of activities focused on continuously improving business and operational activities within the bounds of ethical behavior and regulatory requirements.  The objective of the QSP is to foster a work environment that promotes a safe and rewarding place to do business and build a career. 

All employees participate in the QSP.  Employees are trained on applicable QSP 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. 

The backbone of the QSP is the workflow of business and operational activities.  The ribs attached to the backbone are the QSE listed below.  Each QSE has associated policies and/or procedures that describe activities related to the assurance of quality.

Corporate Compliance                                            Information management/Paper and Electronic

Documents and Records                                       Occurrence Management

Organization and Business Operations                 Assessments

Personnel                                                               Process Improvements

Equipment                                                              Customer Service

Services, Purchasing and Inventory                     Facilities and Safety

Process Control


GLP QC Metrics & Standards
CLIA Proficiency Testing
 
     
 

Good Laboratory Practices (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.

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Clinical Laboratory Improvement Amendments of 1988 (CLIA)
In response to client requests, Expression Analysis has registered to obtain CLIA certification under 42 CFR Part 493. The provisions of this federal requirement allows for laboratory testing of human samples in clinical and diagnostic applications. These efforts are supported by Anne Pontius, our Senior Director of Quality Systems.


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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.

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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.

Click here for the product description, Human Proficiency Testing Program for Microarray Laboratories

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