Lepore, P.D., 1992. FDA's good laboratory practice regulations and computerized data acquisition systems. Chemometrics and Intelligent Laboratory Systems: Laboratory Information Management Systems, 17: 283–287. The Food and Drug Administration's good laboratory practice regulations apply to computerized systems that are used to collect and process data deriving from a non-clinical laboratory study. Such systems are considered to be ‘equipment’ and are regulated similarly to other equipment used in a laboratory. In this regard, computerized systems are to be of appropriate design and adequate capacity to accomplish protocol directions, and their fitness for use in a study is to be documented. Written, approved standard operating procedures are to cover system testing, calibration, standardization, inspection, and maintenance, and a historical file is to contain a listing of versions and dates of implementation. The system is to accommodate the identification of each individual responsible for direct data entry at the time of entry. Data entries may be changed but an audit trail must preserve the original entry and identify the person making the change, list the date of the change, and provide a reason for the change. In view of the forgoing, FDA's inspections of computerized systems are designed to determine whether the systems operated properly in the past, whether they are currently operating properly, and whether they will continue to operate properly in the future. A satisfactory outcome can best be achieved through the development, installation, use, and maintenance of systems comporting with high quality standards.
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