The Quality Control unit is responsible for guiding and coaching system teams in validating computerized systems used in clinical research trials to FDA standards. The main duties include directing validation projects and documentation packages for multiple clinical trial and medical management systems, ensuring system compliance to UM Quality Assurance standards, FDA regulations, and other related external and internal requirements, and developing departmental standard operating procedures and work instructions as needed for performing system validation work. This unit supervises the document creation, approval, and dissemination process, development of standard operating procedures, reports, system quality reviews, identifying deficiencies, completing traceability matrices, preparing CAPA (Corrective and Preventive Action) documents, test scripts, change control or change management, process and strategy planning with computer systems validation of clinical research systems and laboratory applications in regulatory scope for FDA part 11 and other compliance frameworks such as HIPAA, FISMA.

21 CFR Part 11 Compliance If you are conducting clinical research or any other activity that is mandated by Title 21 Code of Federal Regulations and are using computerized systems to carry out those activities, then these systems require validation to meet FDA requirements. Non-compliance with 21 CFR Part 11 may result in FDA sanctions, including exclusion of clinical investigator’s research. Please contact the Quality Control group for guidance on system validation and ways to comply with regulation.

Reference Material:
  • Guidance for Industry: Part 11 Electronic Records and Signatures - Scope and Application
  • Guidance for Industry: Computerized Systems Used in Clinical Investigations
  • General Principles of Software Validation; Final Guidance for Industry and FDA Staff