GxP Compliance Services:

  • Compliance oversight and collaboration with Research Information Technology on the validation of computerized systems used in FDA-regulated research
  • Point of contact for information related to FDA's Part 11 regulation
  • Training on FDA's 21 CFR Part 11 regulation
  • Quality Assurance services
  • Creation of institutional policies for clinical research
  • Compliance liaison with UM's GMP manufacturing facilities

Contact the GxP Compliance Director for questions related to:

  • FDA’s regulation on Electronic Records & Electronic Signatures (21 CFR 11)- aka “Part 11”
  • Determining if an electronic system used in clinical research is, or needs to be, Part 11 compliant
  • Computer system validation records
  • Inquiries from external auditors, including federal agencies and industry sponsors, related to Part 11 or computer system validation records 
GxP Compliance Director 
Helen Miletic hmiletic@med.miami.edu

Please email all Sponsor or CRO-provided Electronic Medical Record Assessment Questionnaires to Helen Miletic for completion