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Clinical/GLP Sequencing Service Overview
The industry standard for Clinical/GLP DNA sequencing is only 4x sequencing coverage of a given template under FDA regulatory standards. 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 Quality Assurance Program including:
- Complete Clinical/GLP regulatory compliance and CLIA Certification.
- Fully validated procedures.
- 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 documentation maintained throughout.
- All projects audited by a Quality Assurance staff.
SeqWright takes great pride in its experience in, and understanding of, the science and regulatory conditions 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
Additional Regulatory Sequencing Services Available
Contact a sales representative about these services.
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