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Legal Implications of Software Validation

Drug Information Journal, 1987
The computerization of the pharmaceutical industry has been progressing at a rapid pace and no end to these advances is in sight. The proliferation of this technology has required the Food and Drug Administration (FDA) to focus more closely on the Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) implications of the use of computer ...
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Legal validity and decided cases

Legal Studies, 1981
This paper is divided into two sections. In the first section I examine the central role played by the concept of ‘legal validity’ in positivist theories of law. I suggest that this concept is capable of varying interpretations, of which some are wholly inapplicable to case law, while others are inappropriate, suggesting a misleading model of case law ...
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