The MIRM-CPCS is a Pitt service center operating under the guidance of an internal Quality Management Systems (QMS) program implementing elements based on the Food and Drug Administration’s Good Laboratory Practices Regulations (21CFR58) as the general reference standard for quality and data integrity.
The CPCS QAU Program emphasizes an approach of continual process improvement by the implementation of a “tiered system” of standard operating procedures (SOPs) supporting ongoing personnel training, stringent documentation standards, data collection practices, and equipment maintenance and calibration schedules. These documents are controlled in our electronic Quality Management System (eQMS), Q-Pulse. These efforts are monitored by active internal QA inspections/audits resulting in reports to McGowan Executive Management providing the platform for overall process and data/systems integrity.
Though the University of Pittsburgh, McGowan Institute and the CPCS does not provide assurances to the FDA GLPs regulations, all CPCS personnel are trained from a range of basic to advanced knowledge in GLP principles; recurring training is provided on a yearly basis.