qOffers 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.q1995 International Validation Forum. D. Process Documentation Most computer systems are capable of generating accurate and detailed documentation of the drug process under computer control. ... For example, at the conclusion of a run the computera#39;s memory may be downloaded and the controlling program reset.
|Title||:||Validation Compliance Annual|
|Author||:||International Validation Forum|
|Publisher||:||CRC Press - 1995-02-17|