Compliance
We, like many of our clients, work in regulated businesses where federal and international laws and regulations govern our conduct. In addition, we abide by other international standards because these have been shown to systematically improve quality. We take these various aspects of compliance seriously at all levels within our organization, and our clients can see it in our communications and deliverables.
cGLP:
The Code of Federal Regulations section 21 part 58 speaks to any processes which generate data or information from your samples, ensuring that data we deliver to a client are a true reflection of the results we obtain, and therefore can be relied upon when making risk or safety assessments.
ISO-9001:2000
In addition, Asuragen has chosen to adopt the ISO-9001:2000 standard to ensure that the business practices surrounding our laboratory methods are constantly improving and quality-oriented.
CLIA
The objective of the CLIA program is to ensure quality laboratory testing of human samples in clinical and diagnostic applications. By complying with the CLIA regulations, Asuragen offers clients a clear regulatory path to expedite the transition of a biomarker from "probable valid" to "known valid" and broader use in clinical practice.
Various specific FDA Guidelines:
Interpretation of these laws and regulations can be complex, particularly in cutting-edge areas like gene expression and miRNA profiling. We work with our clients to ensure compliance with existing guildelines, but further by actively participating in studies such as the MAQCII we can help ensure future studies are in line with future guidelines. Learn more about Asuragen Leadership