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 the 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 the MasterControl document management system is provided as needed.
Standard Operating Procedures (SOP)
The Quality Systems Office assists with the preparation, review, and approval of SOPs and assures that they are uploaded to and maintained in our document management system.
Quality Assurance Unit (QAU)
The QAU unit conducts audits and inspections (facilities, equipment, personnel, methods, practices, records, and controls) that conform with GLP/GMP best practices. This includes audits (critical phase, process and facility reporting and vendors), reviews (for protocols, data, training records, and reports), laboratory walk-throughs, and maintaining a master schedule. Audit reports are prepared and sent to the Study Director and Testing Facility Management (TFM) for each audit conducted. Any findings are addressed and approved by the Study Director before the audit is closed out by QAU.
Protocol, Data and Report Review and Auditing
QAU reviews and maintains copies of all study protocols and refers to them when preparing for an audit. QAU reviews interim and final reports for studies as well as reports received from contributing scientists to assure the reported results accurately reflect the raw data. QAU audits the raw data for each study after it has completed the internal quality control (QC) process. QAU prepares a Quality Statement, which is included with final study reports for GLP studies.
The QAU conducts annual GLP or GMP training on campus. The office assists in providing training to laboratories initiating/conducting GLP/GMP studies. The office provides one-on-one QA and SOP-related training for new individuals working in GLP laboratories. The office can also provide advanced GLP/GMP training.
Equipment Management and Change Control
The Quality Systems Office maintains a system for the management of equipment and computer systems and ensures that any changes to equipment, computerized systems, and facilities are identified, evaluated, and documented. The need for calibration, qualification, and/or validation of each piece of equipment is determined by the risk level classification and is defined in the Validation Master Plan. Records of equipment/system calibration, qualification, and/or validation are maintained in equipment files.
Corrective and Preventive Action (CAPA)
The Quality Systems Office establishes, implements, and administers a system to manage and track corrective and preventive actions. The CAPA program leverages metrics from quality control reviews, QA audit findings, and deviations to identify possible trends and address risk areas in order to prevent errors and/or future deviations.
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 or funding agency following completion of the required retention period.