Computerised systems 21 CFR part

Many regulatory agencies and consultants to the pharmaceutical industry throughout the world have put out some sort of guidance in the past concerning the use of computer systems. It is only within the last six years that this guidance has been given the force of law in the USA in the form of 21 CFR part 11 [20]. 

Guidance on the use of computerised systems within the pharmaceutical industry was given in the 1992 inspection guide discussed in the previous section. This concentrated on computerised laboratory data acquisition systems and was concerned with system security, audit trails of changes/deletions and procedures to ensure validity of the data. Since the mid-1990s it has been a US FDA expectation that major computer systems would be validated to ensure these concerns would be addressed. Occasionally the pharmaceutical news-sheets would be full of serious adverse findings with respect to the computer systems of major pharmaceutical companies. 

The following requirements will concentrate only on closed systems. 

The system must be validated to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records. The system must have the ability to generate accurate and complete copies of records in both human readable and electronic form. 

Records must be protected to enable their accurate and ready retrieval through the record s retention period. 

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