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.qThe documentation which has been prepared in the earlier phases of the life cycle is now ready to be provided to the ... that the software developers must also concern themselves with documenting the program which they are writing andanbsp;...
|Title||:||Validation Compliance Annual|
|Author||:||International Validation Forum|
|Publisher||:||CRC Press - 1995-02-17|