Quality Assurance

Quality Assurance (QA) is the systematic monitoring and evaluation of the various aspects of a project, service or facility to maximize the probability that minimum standards of quality are being attained by the given process.

OCR Quality Assurance Services

The UF Office of Clinical Research (OCR) Quality Assurance (QA) team specializes in ensuring the quality of the data related to multiple clinical research processes and workflows, including:

  • OCR intake submissions
  • OnCore and Epic research protocol records
  • OnCore and Epic subject records, including study visit documentation
  • Research billing compliance

CTSI Quality Assurance Services

The Clinical and Translational Science Institute (CTSI) Quality Assurance Services was set up in 2009 and specializes in providing Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) Quality Assurance services to investigators. Services include:

  • Consultation: General advice and assistance with GMP and GLP compliance issues.
  • Auditing: Quality system audits.
  • SOP Development: Assistance in development of Standard Operation Procedures (SOP) to meet regulatory and project-specific requirements.
  • Batch Releases: Audit of batch manufacturing records and batch disposition for clinical trial materials.
  • Training: Introductory presentations about GLP and GMP regulations.