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
Dave Schumacher, RQAP-GLP
Quality Assurance Director
With over 20 years in Quality Assurance, David Schumacher, RQAP-GLP since 2004, oversees the Alturas Analytics Quality Assurance Program. David is an experienced Quality Assurance Professional in FDA regulated environments and auditor in numerous analytical techniques. His emphasis is in bioanalytical (LC−MS/MS and ligand binding) and formulation assays.