(1999; 168 pages) [Spanish]
6.3 Batch production records
Computer systems are increasingly used to initiate, monitor, adjust and otherwise control manufacturing processes. These operations may be accompanied by recording charts that show key parameters (e.g. temperature) at suitable intervals, or even continuously, throughout the process. In other cases, key measurements (e.g. pH) may be displayed temporarily on a monitor screen, but are not available in hard copy.
Records showing addition of ingredients, actual performance of operations by identifiable individuals, and other information usually seen in conventional records, may be missing. When computers and other sophisticated equipment are employed, the emphasis must change from conventional, hand-written records to:
- systems and procedures that show the equipment and software is in fact performing as intended;
- checking and calibration of the equipment at appropriate intervals;
- retention of suitable back-up systems such as copies of the program and files, duplicate tapes or microfilm;
- assurance that changes in the program are made only by authorized personnel and that they are clearly documented and validated.