Regulatory Licensing
We are committed to providing unparalleled service for each doctor, patient, and clinical trials customer we serve. Our state-of-the-art laboratories adhere to the highest levels of regulatory standards in order to ensure the highest quality results. Our clinical laboratories are HIPAA-compliant, CLIA-certified, and CAP-accredited and hold licensure in several US states. Click below for more information about the licensure and quality assurance programs for each of our locations. [tabs] [tab title="Rutherford, NJ" active="active"] Our Rutherford, NJ laboratory is HIPAA compliant, CLIA-certified, CAP-accredited, and holds licensure in several US States.- CAP Accreditation – Lab Number – 7191582 AU-ID: 1434060
- CAP Certificate for Education Programs – 71915-82-03
- CLIA Certification – 31D1038733
- California License – COS 00800558
- Florida License – 800018142
- Maryland License – 1395
- New Jersey License – 0002299
- New York State License – PFI 8192
- Pennsylvania License – 031978
- Rhode Island – LCO01204


- CLIA Certified – 34D1009209
- CAP Accreditation – Lab Number – 8663918 AU-ID: 1658943
- CAP Accredited Biorepository
- 21 CFR 58 compliant (GLP)
- 21 CFR 11 compliant (Electronic Signatures)
- ISBER Best Practices
We pride ourselves on setting and maintaining a high standard of quality in the PGx industry. While regulatory guidelines for the PGx industry are evolving, through participation with the FDA, EMEA, Laboratory Standards Committee, and other regulatory bodies, we have adopted and implemented company-wide policies and procedures that meet and exceed regulatory guidelines. Quality Systems CGI’s clinical trial clients benefit in knowing that data used to support their ongoing clinical trials is robust and can be used directly in drug approval submissions. Quality control steps are incorporated throughout Gentris’ sample preparation, testing, and storage processes. Internal quality audits are conducted during all key phases of clinical sample processing and our Raleigh, NC facility complies with FDA guidelines 21 CFR Part 58 and Part 11 by:
- Assay Validation: Validation of assays for reproducibility and reliability.
- Equipment Validation: Validation of essential equipment, including installation, qualification, operational qualification, and performance qualification.
- SOP Implementation: Writing, reviewing and implementing SOPs.
- Training: Employee performance training and proficiency testing on all procedures prior to working on any contracted clinical project and prior to validating equipment or assays.
- Reporting: Procedures such as protocol and final report writing, chain-of-custody maintenance, and results reporting are in compliance with pertinent FDA guidelines.
- Chain of Custody: Complete sample tracking via LIMS
- Archive / Server Room: The on-site archive is equipped with an HFC-125 fire suppression system that is tested semi-annually.
- Disaster Recovery Program: Back-up systems, redundant hard-drive data storage, a redundant dual server system, tape back-ups and a long-term backup generator.


- CLIA Certification – 05D1066073
- CAP Accreditation – CAP#: 7209131; AU-ID: 1506668
- California – CDF00335062
- Florida – 800024084
- Maryland – 1471
- New York – PFI8384
- Pennsylvania – 030842
- Rhode Island – LCO00969

