We believe data integrity is the single most important component of our bioanalytical services. The Alturas Analytics’ independent Quality Assurance Unit (QAU) provides the vision, scope and strategies that assure a high standard for all projects conducted in support of registrations worldwide. 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. The QAU is responsible for review of all specific quality policies and procedures through every phase of development and implementation. 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
Quality Assurance professionals at Alturas are active members of the Society of Quality Assurance (SQA). The Bioanalytical Specialty Section of SQA serves as a network resource addressing regulatory compliance questions as applied to GxP bioanalytical testing. The QA staff remains current with industry regulations, standards, and guidance documents by attending national and regional meetings, workshops, and webinars sponsored by SQA and other relevant organizations.
- Bioanalytical Method Validation, Guidance for Industry (FDA)
- Society of Quality Assurance (SQA)
- Canadian Forum for Analytical and Bioanalytical Sciences (CFABS)
- Global CRO Council (GCC)