About the Quality Systems Office
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 either Good Laboratory Practices (GLP) or Good Manufacturing Practices (GMP) certification to adhere to governmental regulations. These federal regulations apply when conducting safety studies and, in some cases, efficacy studies on products including devices, pharmaceuticals and cell-based therapies.
How the Quality System Office Can Help You
The Quality Systems Office is equipped to provide training, document management, auditing, and advising in accordance with the GLP/GMP regulations. This office is also responsible for quality assurance preparation and review of reports. Other services include continuous training for the GLP and GMP community on campus and for individual laboratories when needed. The Quality Systems Office is composed of both Document Management and Quality Assurance units. The Document Management unit can provide document control solutions including development of SOPs, their storage and dissemination. The Quality Assurance unit can assist with protocol and report reviews, data audits, critical phase inspections, facility audits and vendor audits in order to assist in maintaining the integrity of a nonclinical study. The Quality Systems Office is also responsible for archiving GLP/GMP materials at the completion of a study.
Responsibilities of the Quality Systems Office
The office is charged with maintaining GLP/GMP standards on campus. This includes:
Document and Database Management
Currently MasterControl is the content server being used to develop, store, collate, communicate and archive critical documents in a secure and confidential manner. This system is a 21CFR Part 11 compliant system. The office is responsible to maintain this system for users. Training for document management skills using MasterControl document management system is provided as needed.
Standard Operating Procedures (SOP)
The office will assist with the preparation of SOPs, assure that they are uploaded to our document management system and monthly updates of SOPs are provided.
Quality Assurance Unit (QAU)
The QAU unit will provide audits and inspections (facilities, equipment, personnel, methods, practices, records and controls) that conform with GLP/GMP best practices. This includes audits (critical phase, facility reporting and vendors), reviews (for protocols, data, training records and reports), laboratory walk-throughs and maintaining a master schedule.
The QAU will set up annual GLP or GMP training on campus. The office will assist in providing training to laboratories beginning GLP/GMP studies. The office is eager to provide one-on-one QA and SOP-related training for new individuals working in GLP laboratories. The office can also provide advanced GLP/GMP training.
The responsibility of the Quality Systems Office is to archive GLP/GMP related materials after the completion of the study. The archived materials will be returned to the Study Director for their records or to return to the funding agency a year after completion of the study.