Description:
The validity of computer-entered and computer-generated toxicology data is currently of concern to the quality assurance professional. In order to insure this validity, a suitable quality assurance program must be devised. This program should include (1) maintenance of standard operational procedures for both system maintenance and operation, (2) documentation of program changes, (3) inspection of automated data collection, (4) audit of acquired data, (5) establishment of the data trail, including the use of intermediate printouts and inspection of edit procedures, (6) validation of security procedures, and (7) documentation of system failure.