Recently, an increasing amount of application software has become available that is neither internally developed nor “off-the-shelf.” Rather, many packages allow varying degrees of customization without compromising the integrity of the system kernel. In order to be used successfully in the pharmaceutical industry, such systems must be maintainable as well as hold their own under regulatory scrutiny. In brief, they must be documented and controlled. A software configuration specification (SCS) can be used to document and control purchased systems that require this special type of treatment.
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