Clinical/GLP FDA Standard Sequencing Service Overview

To meet FDA regulatory requirements, the industry standard for Clinical/GLP DNA sequencing is only 4x bidirectional sequencing coverage of a given template. These minimal criteria can not always guarantee high quality, accurate sequencing information. To exceed regulatory requirements and client/sponsor expectations, SeqWright maintains a steadfast dedication to quality, rapid project turn-around, and client satisfaction which are complemented by an established, independent Quality Assurance Program which includes:

Complete Clinical/GLP regulatory compliance and CLIA Certification.
Fully validated procedures.
Regularly schedule equipment calibrations.
Quality inspections.
Established SOP’s and program procedures.
Assay transfer capabilities.
Ongoing personnel training on SOP’s and procedures.
Restricted laboratory access.
Complete project documentation maintained throughout.
All regulatory projects audited by a Quality Assurance staff.

SeqWright takes great pride in its experience in, and understanding of, the science and regulatory requirements necessary for the characterization and reporting of Clinical/GLP sequencing data. We encourage all potential clients to schedule an on-site audit to inspect our Quality Assurance Program. Read about our client's recent FDA successes.

Regulated Sequencing Service Features

Regulatory Compliance:
- 21 CFR 58 (GLP)
- 21 CFR 11 (Electronic Signatures)
CLIA certification.
Minimum 4x sequencing coverage.
Stringent Phred quality scoring of sequence trace data and consensus data.
Sequence variation reporting.
Gene Transfer Vector Characterization (more info).

Additional Regulatory Sequencing Services Available

Nucleic Acid Extraction (DNA, RNA) and amplification (PCR, RT-PCR).
Primer Walking.
Shotgun Sequencing.
SNP re-sequencing.
Viral RNA Sequencing (experienced with influenza, WNV, rotavirus & more) (more info).
Custom Molecular Biology

Contact a sales representative about these services.