Gentris prides itself on setting and maintaining a high standard of quality in the PGx industry. While regulatory guidelines for the PGx industry are evolving, Gentris, through participation with the FDA, EMEA, Laboratory Standards Committee, and other regulatory bodies, has adopted and implemented company-wide policies and procedures that meet and exceed regulatory guidelines.
Gentris Quality Systems
Gentris’ clients benefit in knowing that data used to support their ongoing clinical trials is robust and can be used directly in drug approval submissions, as detailed in the FDA Guidance Document Pharmacogenomic Data Submissions (U.S. Department of Health and Human Services, FDA, March 2005) and FDA Draft Guidance Document Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase Clinical Studies (U.S. Department of Health and Human Services, FDA, February 2011)
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. Gentris 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.
Gentris welcomes sponsors to conduct site visits and vendor audits.