Since results generated in DNAVision may be submitted to authorities controlling the pharmaceutical and agro-alimentary 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.
DNAVision is the first contract research laboratory in Belgium to be GLP certified for pharmacogenomic and toxicogenomic studies. DNAVision succeeded GLP certification audits for pharmacogenomic/toxicogenomic studies on medicinal products according OECD and EU guidelines. The GLP Compliance Program includes Pre-inspections, Test Facility Inspections, Study Audits and Re-inspections. During the Test Facility Inspection, not only organization of the test facility but also on-going and completed studies were verified.
View our GLP compliance certificate (# D01)
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 included pharmacogenetics and pharmacogenomics activities for which DNAVision is proud of being the first European laboratory to be ISO 17025 accredited (SNP genotyping (e.g. CYP450 genotyping, Affymetrix genotyping) and expression profiling).
Belac Accreditation number : 293-TEST (351-T BELTEST)
View our accreditation certificate (EN - FR -NL - D)
Our scope can be viewed on the Belac website.
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.
View our CAP certificate (LAP Number 7205911)
DNAVision SA is registered with the United States Federal Government's clinical laboratory oversight program (CLIA).
DNAVision has been recognised GMP by the "Agence Fédérale des Médicaments et des Produits de Santé" in the field of biopharmaceutical analyses (DNA sequencing, PCR, ...)
DNAVision is member of Eurogentest. The mission of Eurogentest is to harmonize genetic testing across Europe.
Eurogentest number : EUGTBE81273
DNAVision SA is certified by the Agence Fédérale de la Sécurité de la Chaîne Alimentaire (AFSCA) until 2010.
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.
DNAVision SA has been acknowledged by French authorities (ministère de l'enseignement supérieur et de la recherche) as an "agreed CRO". So, DNAVision' invoices for service are now eligible to CIR (Crédit d'Impôt Recherche), up to of 30% of the total amount.