Quality Assurance: GMP, ISO17025, CLIA, CAP
Since results generated in DNAVision may be submitted to authorities controlling the pharmaceutical and agrifood industries, we have set up a Quality System to ensure our services meet the quality standards required by regulatory bodies and by our customers.
The accuracy and reproducibility of data are crucial. Strict Quality Assurance procedures and monitoring by internal audits and external authorities are important features of the DNAVision Quality Management System.
ISO 17025 is an international standard that assesses the technical competency of analytical laboratories and helps to ensure accurate data generation, controlled test methods and procedures, and properly trained personnel. ISO 17025 covers every aspect of laboratory management, including sample preparation, analytical testing proficiency, report generation and record keeping.
This accreditation includes pharmacogenetics and pharmacogenomics activities and DNAVision is proud to be the first European laboratory to be ISO 17025 accredited for SNP genotyping and for expression profiling.
Belac Accreditation number : 293-TEST (351-T BELTEST)
DNAVision has been awarded an accreditation by the Commission on Laboratory Accreditation of the College of American Pathologists (CAP) to provide pharmacogenomic and pharmacogenetic testing.
The CAP Laboratory Accreditation Program is an internationally recognized program and the only one of its kind that utilizes teams of practicing laboratory professionals as inspectors. Designed to go well beyond regulatory compliance, the program helps laboratories achieve the highest standards of excellence to positively impact patient care.
The program is based on rigorous accreditation standards that are translated into detailed and focused checklist questions. The checklists, which provide a quality practice blueprint for laboratories to follow, are used by the inspection teams as a guide to assess the overall management and operation of the laboratory.
The CAP Laboratory Accreditation Program meets the needs of a variety of laboratory settings from complex university medical centers to physician office laboratories. The program also covers a complete array of disciplines and testing procedures. Because of its comprehensive nature, CAP accreditation can help achieve a consistently high level of service throughout an institution or healthcare system.
The Centers for Medicare and Medicaid Services (CMS) has granted the CAP Laboratory Accreditation Program deeming authority. It is also recognized by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), and can be used to meet many state certification requirements. The CAP also provides laboratory accreditation to forensic urine drug testing and reproductive laboratories, co-sponsored with the American Society for Reproductive Medicine (ASRM).
DNAVision SA is certified within the United States Federal Government's clinical laboratory oversight program (CLIA).
DNAVision is member of Eurogentest. The mission of Eurogentest is to harmonize genetic testing across Europe.
MicroArray Quality (MAQC) Project
The MicroArray Quality Consortium (MAQC) project (http://www.fda.gov/nctr/science/centers/toxicoinformatics/maqc/), is a community-wide effort that aims to provide quality control tools to the microarray community in order to avoid procedural failures and to develop guidelines for microarray data analysis by providing the public with large reference datasets along with readily accessible reference RNA samples.The results of phase 1 of the MAQC project, published in the September 2006 Nature Biotechnology special issue (http://www.nature.com/nbt/focus/maqc/index.html) have shown, between other things, that gene expression measurements showed inter- and intraplatform reproducibility.
The second phase of the MAQC project is primarily focused on predictive classifiers (signatures) for health outcomes based on microarray data. DNAVision has used its in-house developed tools (http://www.dnavision.com/pharmacogenomics/custom_bioinformatics.php) for the quality control analyses of phase 2 datasets.
CIR (Credit Impot Recherche)
DNAVision SA has been acknowledged by French authorities (Ministère de l'enseignement supérieur et de la recherche) as a recognized CRO. This means that DNAVision invoices for services provided are now eligible for a reduction of up to of 30% of the total amount via the CIR (Crédit d'Impôt Recherche).