CLIA, GLP and CAP Sequencing Projects

Overview

GLP-Compliant Confirmatory Sequencing

Sequence confirmation by primer walking or by PCR amplification and sequencing.

Sequence confirmation is critical in preclinical and production pipelines, especially if you plan for a FDA and/or EPA submission. GLP-compliant sequencing offers an added layer of documentation, quality control, and process control to support regulated and non-regulated industries confirm their sequences with confidence. It combines Sanger sequencing, which is already the gold standard for sequence confirmation with a 99.9999% accuracy rate, with the quality standards of a preclinical lab. Our GLP-compliant sequencing services include:

Quality control of incoming DNA
Design and synthesis of required primers
Double strand sequence confirmation (2fold or 4fold coverage) by primer walking or by PCR amplification and sequencing
Guaranteed accuracy of final data: 2fold coverage: > 99.999% and 4fold coverage: > 99.99999%
Nucleic acid extraction, reverse transcriptase or DNA cloning are available on demand.

Benefits

Established quality management system that is compliant with GLP guidelines set by the FDA.
Established leader in Sanger sequencing with experience, equipment, and expertise in this field.
Dedicated Study Director and resources.
Outstanding support throughout the process.
Complete report the covers every aspect of the process, reagents, methods, and results.

To ensure the quality of our GLP certified sequencing service, we are routinely assessed by first and second external auditors. Additionally we perform regularly facility and process audits.

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Licenses & Accreditation

Eurofins Genomics US meets or exceeds the FDA guidelines for GLP regulations, as set forth in the FDA compliance standards 21CFR58. The United States FDA does not administer a formal licensure, accreditation or registration process or requirement for GLP laboratories. Eurofins Genomics maintains the required quality management systems, functional positions, and documentation standards to adhere with FDA GLP standards. In addition, Eurofins Genomics carries the highest quality standards for both clinical and non-clinical samples, including CLIA, CAP, GMP (FDA), ISO 9001, and ISO 13485. ISO 17025 is also available from our European faculty if necessary for your project.

Our expertise and experience is just one of the reasons why our GLP certified sequencing service is excellent for non-clinical laboratory studies. Our GLP sequencing service includes the following features:

Fully validated procedures and equipment
Regularly equipment calibrations
Continuous personnel training on SOP's and procedures
Restricted laboratory access
Established SOP's and program procedures
Complete study documentation
Complete sample tracking for uncompromised sample and data integrity (chain of custody)
All studies are inspected by our independent quality assurance department
Comprehensive reporting including study plan and final study report

ISO 17025 and OECD

Our QM and QA system for DNA sequencing is based on regulatory requirements, (OECD-GLP, acknowledged standards (ISO 9001 / ISO 17025) and best practices (CLSI).

If your project requires ISO 17025, Eurofins Genomics is the perfect partner. Our European division is certified in ISO 17025 and meets the OECD-GLP, acknowledged standards and best practices (CLSI). Sequencing is performed according to standard methods and in compliance with:

CLSI Guideline MM9-A; Vol. 24 Nr. 40, 2005; Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine, Approved Guideline, 2005

Conduct of sequencing studies is performed according to

OECD Guideline ENV/MC/CHEM(98)17 (rev.1999): The Principles of Good Laboratory Praxis (Monograph No. 01) and OECD Guideline ENV/JM/MONO(1999)23 (rev. 2002): Short Term Study and GLP (Monograph No. 07)

Quality assurance (QA) activities related to sequencing studies (review of the study plan, inspection of study, study report and raw data) are conducted according to