UAMS.EDU

Quality Assurance

The Quality Assurance Unit (QAU) of The Office of Research Regulatory Affairs at UAMS focuses on six key systems of good practice regulations for research and non-research entities in order to provide the most comprehensive support services to UAMS investigators and also to UAMS affiliates.  Those key systems include:

  • Quality Assurance
  • Facilities and Equipment
  • Materials
  • Manufacturing and Processing
  • Packaging and Labeling
  • Laboratory Controls (Systems and SOPs)

The QAU personnel are committed to providing the best in essential support to investigators in navigating the federal regulations leading to the development of well-designed, and innovative ethical studies in a continuously changing research environment.

The services we provide are:

  • Consultation Regarding Applicable Regulations
  • Standard Operating Procedure Development
  • Performance of Manufacturing Analysis
  • Determination of Facility Requirements
  • Drug Manufacturing Project Management
  • Review of Drug Substance
  • Planning and Establishment of Manufacturing Process Controls
  • Establishment of Packaging and Labeling Controls
  • Determination of Analytical and Documentation Requirements
  • Qualification/Validation Services
  • Record Review and Quality Auditing Services
  • Environmental Monitoring Consultation

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