Quality assurance unit manager

Quality assurance unit Any person or organizational element, except the study director, designated by testing facility management to perform the duties relating to quality assurance of the (non-clinical laboratory) studies. 

Testing facility management Study director Quality assurance unit General... 

Not surprisingly, many comments objected to the requirement for a quality assurance unit on the basis of increased costs, administrative burden, and interference with management prerogatives and informed scientific judgment of study directors. An alternative solution for study monitoring was not suggested, however. 

The quality assurance unit (QAU), the duties of which are described in Part 58.35, presents a special challenge to the FDA investigators. By evaluating QAU activities, the agency is able to assess the mechanisms by which the facihty management assures itself that the nonclinical laboratory... 

Approved by Each page of the quality manual has a space to provide the name, title, and department of the person in the quality assurance unit or the management representative approving the manual with signatures and the date. 

Management has both directive and supportive responsibilities for the operations of the quality assurance unit to fully achieve compliance with Good Laboratory Practice regulations (1,2). The tone for the entire testing facility is set by management since it is their ultimate responsibility to establish and endorse procedures and policies which ensure a commitment to quality. 

Quality Assurance, the responsibility of the quality assurance unit, is the nitpicking, but totally necessary, job of determining the quality of conformance to regulations established by managers and their chemists and is done via audits and inspections. To develop a thorough quality program both quality control... 

The first step is for someone in management to recognize the need for computer systems validation and to gather the other management expertise necessary to address the issue. This person is usually someone in the Quality Assurance Unit (QAU) or the computer operations, Management Information Systems - MIS, group. While these two departments need to be involved, computer systems users such as laboratory leaders, study directors, and other affected department managers need to be included in the development of a computer systems validation plan. 

For each nonclinical laboratory study, testing facility management shall...(c) assure that there is a quality assurance unit. (e) ensure that personnel, resources, equipment, materials, and methodologies are available as scheduled, (f) assure that personnel clearly understand the functions they are to perform, (g) assure that any deviations from these regulations reported by the quality assurance unit are communicated.. . and corrective actions are taken and documented. 

The quality assurance unit is responsible for monitoring each study to assure management that... 

Management must designate a Study Director, who establishes a Quality Assurance Unit and is responsible for validating results. 

The Quality Assurance Unit is mandatory and separate from study management. 

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