Computer control records, retention

Note Procedural controls for computer applications may include development, use, and support of systems, data handling, storage and retrieval, maintenance, repair, calibration of equipment, management and personnel responsibilities, record retention, training. 

Narrowly focused, the tenets of 21 CFR 11 are indisputable that firms must establish and maintain the integrity of their electronic information. What has been lost is the clear indication of which electronic information the requirements apply to. In my opinion, data generated outside a computerized system, that are manipulated by that system and are ultimately available in hard copy should not be subject to this ruling. Validation of the computerized system should be more than sufficient to establish that the final documentation accurately reflects the input information. In that instance, the computerized system is little more than a tool whose functionality can be readily established, yet firms are endeavoring to assure 21 CFR 11 compliance for numerous systems in which the computer is little more than an adjunct to the cGMP activity and corresponding hard copy. Batch record preparation, SOP and test method archives, and many process equipment control systems are examples of systems in which requirements for 21 CFR 11 compliance appear excessive. A system that processes or communicates data or records and subsequently retains and stores hard copies should not be subject to the 21 CFR 11 requirements. Far too many systems are being unnecessarily held to the very restrictive portions of 21 CFR 11. Electronic record retention as defined in 21 CFR 11 has its place, but not necessarily in every computerized system used within the industry. 

Document tracking CRF correction Data entry Data coding Quality control system Computer system, software Data reporting Record keeping Record retention Training initiatives... 

Audit trails must be available for the duration of a record s retention period and protected from any form of alteration. It should be possible to establish the current value and all previous values of a record by using the audit trail. Normal working practices (procedural and built-in computer controls) should prevent audit trail content being altered without definitive authorization by a second documented supporting party. Audit trails need to be available with their electroruc records in human readable form for purpose of inspection. 

To get around these limitations, the FID, BCD or TCD can be replaced with a mass spectrometer equipped with an electron impact ionization source. In most cases, the mass spectrometer is of the quadrupole variety (see Chapter 3 for further details). The instrument works by recording a whole series of mass spectra, one after the other, as the analyte elutes through the column. In this way, important analytical information is obtained from both the retention time and the mass spectrum. The mass spectrum recorded for a particular GC peak can be compared with those stored in a library on the control computer, which usually allows compound identification. GC-MS is an extremely valuable analytical tool, but it suffers from a lower detection sensitivity than GC-FID because of the scanning time of the mass spectrometer, and so for air analysis it is often used more for compound identification than for quantification. 

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