Quality Management System (QMS)

Overview

The Quality Systems Office is independent of individual laboratories and has been established to provide training, document management and auditing expertise for studies that require Good Laboratory Practices (GLP) to adhere to governmental regulations described in 21 CFR Part 58. The Quality Systems Office assists organizational units or individual laboratories with establishing and maintaining compliance with the GLP regulations. Each research group conducting GLP-compliant research or providing services to GLP-compliant studies must be approved prior to organizational commitment. The Quality Systems Office will assist and ensure the requirements can be met by the investigator’s organization. If your unit or laboratory is interested in conducting GLP-compliant studies, the Quality Systems Office highly recommends scheduling a consult as early as practically feasible.

In addition to establishing a GLP-compliant quality system, the Quality Systems Office can also help laboratories conducting basic or translational research that does not require strict compliance with the FDA regulations with establishing a rigorous and robust quality system. This includes study protocol and standard operating procedure development, critical phase, process, and facility audits, as well as training and performance monitoring.

Leadership

  • Karen Hughes, Test Facility Manager
  • Michelle Ross, Director of Quality Assurance
  • Susan Messics, Manager of Document Control

Learn more about the team here.

Contacts

Name Role Phone Email Location
Michelle Ross, BS
Director of Quality Assurance
 
410.706.5450
 
maross@som.umaryland.edu