Origins of the computer-validation concept and approach
Although the concept of good manufacturing practices (GMPs) dates back to the early 1900s, current GMP regulations are mostly
based on the practices that were revised in the mid-1970s, when the medical-device regulation amendments were introduced.
It was during this time period that the manufacturing-validation concept (now known as process validation) was first discussed
by FDA officials Bud Loftus and Ted Byers (3). In the late 1980s, the manufacturing-validation concept and approach of conducting
IQ, OQ, and PQ were applied to computer validation. This approach was selected in part for the benefit of the relationship
between industry and FDA. It was hoped that FDA would accept the computer-validation approach because it was already familiar
with and accepting of the IO, OQ, PQ concept. Within the industry, applying IQ, OQ, PQ to computer validation was challenging
at first. This was at a time when validation concepts such as unit testing, module testing, and integration testing in information
technology and software engineering already were being practiced. Interestingly, this IQ, OQ, PQ concept has withstood the
test of time and is still prominent today, although some may have substituted and intertwined other types of testing into
the fold, including unit and integration testing, as well as other variations of testing (e.g., site-acceptance testing and
factory-acceptance testing).
Perspective on regulations and regulatory guidance
Related FDA documents
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Some believe computer validation has been mandatory for only a few years. Most computer validation practitioners believe it
started in 1983 with FDA's publication of Guide to Inspection of Computerized Systems in Drug Processing (known simply as "The Blue Book") (4). FDA documents related to computer systems were published as early as 1976 and 1977,
however (see sidebar, "Related FDA documents") (5–7). The 1976 FDA Inspector's Technical Guide provided inspectors with the following guidance (6):
An understanding of computer operation, and the ability to use a computer, does not require a detailed knowledge of either
electronics or the physical hardware construction. An overall view of the computer organization with emphasis on function
is sufficient.
Computer-validation articles published
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Additional guidance was provided in the 1977 FDA Inspection Technical Guide Part II: "The accuracy and validation of the program is one of the most important aspects of computer control" (7).
Clearly, FDA regulations and expectations have changed since the late 1980s. More detailed documentation is now required to
support and verify a system's quality. FDA publications also have become increasingly specific (e.g., in clinical system guidances
and those governing the food-processing industry) (8, 9). FDA has a better understanding of the technology and its capabilities
as a result of its body of national experts on computer systems, as well as the proliferation of computer and automated systems
in the industry. Several other countries also have computer-validation requirements in their GMP regulations (10, 11).
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