Offers an overview of validation and the regulatory climate and provides a compendium of the regulations, guidance documents, issues, terminology, and literature involved in computer systems validation. This title examines regulations issued by the US Food and Drug Administration, the US Environmental Protection Agency, and the European Union.

"Offers an overview of validation and the current regulatory climate and provides a compendium of the regulations, guidance documents, issues, compliance tools, terminology, and literature involved in computer systems validation. Thoroughly examines regulations issued by the U.S. Food and Drug Administration, the U.S. Environmental Protection Agency, and the European Union. Furnishes case studies of real-world situations."