Quality Assurance Program
Mission Statement
The Tulane University Quality Assurance Program is dedicated to the achievement of institutional academic excellence by the provision of services essential for the attainment of rigorous and reproducible data across all research activities.
Overview
The Tulane University Quality Assurance (QA) Program was founded in 2018 and is a pioneering initiative designed to enhance best practices in research laboratories, resulting in the generation of meticulous quality data. The Quality Assurance Unit (QAU) oversees the implementation of the QA program providing the infrastructure to support both regulated and non-regulated nonclinical studies.
Research Services
The QA program uniquely supports the development of quality management systems in laboratories that are not subject to regulatory QA standards and therefore are typically out with the scope of conventional QA coverage. Subsequently, the QA Program aims to bridge this gap and bring best practices to research laboratories to ensure traceability of process, reduction of error, and internal and external reproducibility of data.
The QA program is implemented through a standard quality Plan-Do-Check-Act cycle which focuses on risk identification and continuous improvement. Quality standards are implemented in a stakeholder-driven manner ensuring that rather than acting as a regulatory body, QA personnel work directly and collaboratively with laboratories with emphasis on continuous improvement rather than punitive approaches to nonconformance. Once the working relationship between the laboratory and QA is established, laboratories participating in the program have consistently advanced to a higher standard of QA practices in a data-driven manner to maximize the impact of the program, while successfully minimizing resistance to change.
In addition to providing services to laboratory personnel, the QA program works directly with a variety of support services, including Facilities Services, Biosafety, Occupational and Environmental Health and Safety, and Institutional Management, to ensure facility-level concerns do not impact the integrity of data generated.
Regulated Nonclinical Studies
The QAU is independent of the performance of any research studies and is under the oversight of the Executive Director of Biosafety, Biocontainment Operations, and Quality Assurance and Vice President of Research. This provides the necessary infrastructure to support compliance with regulatory standards for a quality management system utilizing 21 CFR Part 58 Good Laboratory Practice for Nonclinical Studies as a reference standard. In addition, the QAU provides support to regulated high consequence research ensuring compliance with applicable national and international quality management standards.
QAU Services
External Services
The QAU provides consulting and training services to internal and external clients through the Tulane University Biocontainment Institute. For further information on services offered, upcoming trainings, and pricing, contact tubi@tulane.edu
Contact Us:
Phone: (504) 988-0372 (New Orleans Campuses) / (985) 871-6202 (TNBRC)
Email: quality.assurance@tulane.edu
