Evidence data integrity

Once data have been appropriately and accurately entered in the system, processed, and stored, they are presumably available for later comparison, analysis, or combination. That presumption is based on the confidence that the system does not in any way corrupt or modify the data, however. Validation requires evidence of continued data integrity. 

Second, disaster situations represent real and potential threats to data integrity. Evidence of appropriate preventive action and recovery strategies must be presented, generally in the form of a disaster recovery plan with an annual practice drill. The disaster recovery plan is usually organized aroimd likely problems (flood from broken pipes, fire, electrical failure, etc.) and includes appropriate notifications, substitute activities, and recovery actions. The disaster recovery plan generally interacts with system backup, recovery, and archive SOPs. 

Defining and adhering to a validation plan to control the application and system operation, including GMP risk and validation rationale Documenting the validation life-cycle steps to provide evidence of system accuracy, reliability, repeatability, and data integrity... 

Therefore, not only are security measures to be developed which should provide for an optimal protection of data integrity, but the full documentation on, and validation of, these measures will provide the necessary evidence for the effectiveness of the security provisions, which, in turn, will again enhance the confidence in the integrity of the data. 

An important issue for regulatory authorities is the reconstruction of conclusions and reported results. Evidence of data integrity can often he based on the chronological sequence of events. The U.S. Food and Drug Administration (FDA) regulation 21 CFR 11, dealing with electronic records and electronic signatures, mentions in 11.10(e) one of the controls that must be used ... 

Two empirical parameters are evident in equation 7, the heat of vaporization and the integration constant, I. Experimental data indicate that the linear relationship suggested by Clausius-Clapeyron may not be followed over a large temperature range (4) therefore additional adjustable parameters have been added to equation 7 to improve its correlating abiUty. The most prominent of these is the Antoine equation ... 

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