To ensure quality and compliance are never compromised, uniform systems are integrated throughout every level of our organization.
Our quality management system consists of a comprehensive set of Standard Operating Procedures written to comply with provisions of applicable Food and Drug Administration (FDA), Good Laboratory Practice (GLP) regulations, and other global agencies. Alturas Analytics, Inc. has laboratory-wide quality control (QC) and quality assurance (QA) procedures designed to assess and monitor the ongoing integrity of the testing performed in its facilities.
Applicable Code of Federal Regulations (CFR) includes:
FDA GLP for Nonclinical Laboratory Studies, 21 CFR Part 58
FDA Electronic Records Electronic Signatures, 21 CFR Part 11
Speak with an Expert
Jera Kantz, LATG, RQAP-GLP
Quality Assurance Manager
Jera A. Kantz, MBA, LATG, RQAP-GLP, serves as the Quality Assurance Manager at Alturas Analytics, Inc. With over 16 years in the CRO industry, she has experience in the laboratory as a Research Associate, and after gaining her AALAS LATG certification, specializing in the Quality Assurance Auditor and Senior Quality Systems Auditor positions. Jera is incredibly passionate about quality assurance. Influencing others to be embrace compliance leading to intuitively generated quality data and ensuring patient safety is her ultimate goal.