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Quality Assurance

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.

Our Rutherford, NJ laboratory is HIPAA compliant, CLIA-certified, CAP-accredited, and holds licensure in several US States.

CGI is committed to providing reliable and accurate diagnostic services to our clients. Patient safety, in the form of accurate specimen identification and timely communication of life-altering diagnoses is paramount in everything we do. We monitor and improve our performance through a variety of methods, including performance improvement indicators, proficiency testing, external audits, and satisfaction surveys.

All quality concerns and incidents are subject to root cause analysis, and our procedures are all put through periodic evaluation via the Plan-Do-Check-Act model of continuous improvement, to ensure that we are providing the best services possible to our patients and clients. Protection of patient results from misuse or poor access is imperative and thus electronic and paper results are strictly guarded via password-protection and ID cards according to HIPAA guidelines.

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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.

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CGI’s laboratory in Zhangjiang Hi-Tech Park, Shanghai, China meets or exceeds all local regulatory compliance expectations and is both CLIA and CAP compliant.