Quality Assurance Unit

The Quality Assurance (QA) Unit maintains formally approved standard operating procedures (SOPs), laboratory protocols, and animal protocols that define consistent practices followed by the branch. These documents are comparable to SOPs and protocols used in an industry laboratory. The QA process is managed by the program manager. The QA technician is responsible for day-to-day document control activities. Each formal document is independently reviewed for completeness prior to initiation and again at closure by the QA staff.

The purpose of the QA system is to provide continuous improvement to the operations of MVDB based on standard industry practices and the Code of Federal Regulations 21 Part 58. The QA system is part of the larger MVDB management program, which uses past and current information to forecast future developmental plans, study designs, FDA submissions, and clinical trials.