The Quality Management Systems (QMS) Office provides training, document management, and auditing expertise for studies that require Good Laboratory Practices (GLP) or Good Manufacturing Practices (GMP) certification.

These federal regulations apply to safety studies and, in some cases, efficacy studies on devices, pharmaceuticals, and cell-based therapies. The QMS Office is independent of all laboratories. 

Services and Responsibilities

The Quality Management Systems Office is responsible for maintaining GLP/GMP standards on campus; this includes:

• Document and database management using the MasterControl content server
• Standard operating procedure preparation, review, approval and storage
• Quality assurance auditing, reviews, inspections, and lab walk-throughs
• Study protocol, data and report reviews, and auditing
• GLP/GMP training
• Equipment management and change control
• Corrective and preventive action
• Archiving GLP/GMP materials at study completion

Katherine E. Kight, PhD
Research Administrator

410.706.5149
kkight@som.umaryland.edu