- 21 CFR 58 compliant (GLP).
- Expanding implementation of 21 CFR 210/211 (cGMP) regarding testing.
- CLIA certified.
- Validated systems and processes.
- QA approved Standard Operating Procedures (SOP) in place or created for all procedures.
- QA maintained records of personnel training on applicable SOP’s.
- Complete sample tracking via a custom LIMS.
- Project reports reviewed & signed by the Quality Assurance Unit (QAU).
SeqWright’s regulatory compliance (GLP compliance), QA program, personnel and the facility are always open to review by outside auditors (with a formal NDA/CDA in place). We also gladly accept and review all advice regarding improvements and additions to our pre-existing QA program. SeqWright’s strict adherence to the relevant FDA guidelines, compliant laboratory environment and our associated QA program allow our worldwide Pharmaceutical, Government, Biotech and Academic clients to be fully confident that all GLP compliant data is accurate, consistent and surpasses government submission requirements.
Regulatory Compliance Services
- Sanger DNA Sequencing
- SNP/Biomarker Discovery
- Expression Analysis
- Real-Time, Absolute and Allelic Discrimination
- Genetic Stability Testing
- Residual DNA Analysis
- Custom Molecular Biology
Regulatory (GLP) Project Features
Customizable to client requirements.
- Up-Front consultation on study requirements, design, and QA.
- Complete sample anonymity.
- Sample chain-of-custody.
- Continuous real-time sample / data tracking via a customs LIMS.
- Employment of all practicable automation for:
- Rapid high-throughput.
- Consistent performance.
- Complete sample and data security.
- Limited access laboratories and servers.
- Secure website (FTP) data transfer.
- Data back-up on- and off-site
- Immediate and continuous power back-up.
- Project specific BioInformatics.
- Complete project documentation.
- Project specific laboratory notebooks.
- Data archiving.
- QA oversight, deviation and audit reports.
- All materials archived by QA department.
- Accurate reporting with a rapid turn-around time.
- A GLP compliant Final Report is provided at project completion for inclusion in FDA submissions.
- QA Reviewed and signed.
- Formatted for inclusion in FDA submissions.
- Includes details on all SOP’s, materials, equipment and results.