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Pharmaceutical Manufacturing
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The U. S. Food and Drug Administration (PDA), in recent years, has been exerting increasing pressure on manufac­turers of pharmaceuticals and medical devices to validate the quality and reliability of computer systems that are used to manage regulatory data. Such companies are well acquainted with FDA requirements for manufacturing process validation. Most are also familiar with the require­ment to validate systems traditionally owned by Quality Assurance (QA), such as in-process inspection systems and laboratory systems. But some companies have been sur­prised to learn that their production and inventory control (P&IC) systems also must be validated when those systems are used for regulatory compliance functions, such as production batch control, lot tracing, serial number track­ing, and product recall.

This paper will provide an introductory overview to the basic concepts of system validation, with a focus on soft­ware validation. It will describe the elements of a success­ful software validation and will briefly outline the steps required to plan and organize the validation effort.

Overview of System Validation

For purposes of this paper, system validation can be defined as follows:
System validation is a quality assurance process, applied to a computer system, which satisfies management that the total system is operating and will continue to operate as required.

There are several key points contained in this definition. First, it is a quality assurance process. Just as the QA process applied to products and manufacturing processes provides assurance of product quality and reliability, sys­tem validation provides assurance of system quality and reliability.

Second, this definition focuses on management. Validation responsibility cannot be delegated to the MIS department or the software vendor. Ultimately, it is the responsibility of company management and the users of the system to ensure that their system operates and will continue to operate as required.
Third, system validation must be the validation of the total system, that is the software, hardware, and associated human procedures. However, because software validation is typically the most complex part of system validation, this paper will focus primarily on software validation.

Finally, system validation ensures the system operates as required, that is, in terms of its requirements. Ultimately, system validation does not merely ensure that the system performs as designed or programmed, but that it performs according to its requirements. In software development, as in manufacturing, there are often differences between what was designed or built and what the customer wanted.

As a quality assurance process, system validation matches the final product against the true requirements.


The concepts of system validation were developed and applied in the early 1970s by the U.S. Army, with help from academic and industry scholars, as part of the development of the Safeguard Anti-Ballistic Missile System [1]. Since then, it has been an important requirement for aerospace and defense contractors. System validation has also been an integral part of the development of air-traffic control systems, nuclear power plant control systems, and other applications where human safety is at risk.

In the 1980s, as software began to play an increasingly important role in the control of medical devices (e.g., pacemakers, radiation therapy systems), the FDA looked to software validation techniques as a way of ensuring their operational reliability. Several well publicized problems with medical devices have given a sense of urgency to the need for validation.

Recently, the difficulty of some manufacturers in recalling defective products has focused FDA attention on software used in batch control and product recall. This has brought FDA attention, in some companies, to the heart of the company P&IC system, which may have been implemented and maintained for years without any thought of formal validation. In some cases, the FDA has blocked production or sale of certain products until the P&IC system is validated. This usually works to focus management atten­tion on the issue.

To Be Continued


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