Data integrity is foundational to generating reliable bioanalytical data that supports regulatory submissions, informed development decisions, and study reproducibility.
The Alturas Analytics’s independent Quality Assurance Unit (QAU) provides oversight of bioanalytical activities conducted in support of regulated drug development programs worldwide. Through audits, inspections, quality systems management, and data integrity oversight, the QAU helps ensure studies are conducted in compliance with applicable GLP, GCP, and GxP requirements, most relevantly GLP and GCP.
Alturas Quality Assurance professionals remain up to date with evolving industry regulations, standards, and guidance through ongoing professional development and participation in relevant industry organizations. This commitment supports the continued effectiveness of quality systems and regulatory compliance programs across our bioanalytical operations.
Our QAU operates independently from laboratory operations to provide objective assessment of study activities, quality systems, and compliance processes. This independent oversight helps ensure that bioanalytical data are generated, reviewed, reported, and archived according to established procedures and regulatory expectations.
Quality Assurance personnel monitor critical processes, evaluate compliance with approved procedures, and support continuous improvement initiatives that strengthen study quality and regulatory readiness.
Strong quality systems help ensure consistency, traceability, and accountability throughout regulated bioanalytical studies. Alturas’s Quality Assurance oversight includes:
standard operating procedure (SOP) management
These activities help support compliant study execution and confidence in the resulting data.
Quality Assurance at Alturas plays an important role in preparing organizations for sponsor audits and regulatory inspections. Ongoing assessments help identify potential compliance risks and support inspection readiness throughout the study lifecycle.
Audit and inspection activities may include internal process audits, study-specific audits, facility inspections, data audits, quality systems reviews, and sponsor audit support.
We have an exemplary audit history with regulatory authorities. Please use the Speak With an Expert form below to discuss compliance inquiries or to schedule an audit.
Quality Assurance supports GLP compliance through audits, inspections, documentation reviews, training oversight, and monitoring of quality systems designed to maintain study integrity and regulatory compliance.
Independent oversight provides an objective assessment of study activities and quality systems, helping ensure that bioanalytical data are generated and reported according to established regulatory expectations.
As defined by the EMA*, GxP is a collective term for various Good x Practices, including GLP (good laboratory practice), GCP (good clinical practice), GMP (good manufacturing practice), and GDP (good documentation practice). As a best-in-class bioanalytical CRO, Alturas Analytics is especially proficient in GLP, GCP, and GDP.
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.
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