Validation of Computerized Analytical Systems - Ludwig Huber - Bog

Covering the entire validation process, from writing a validation plan through implementation, testing, and installation qualification, to ongoing calibration, performance qualification, and change control, this book provides readers with complete validation details. It discusses international and FDA regulations with numerous practical examples that show readers how to accomplish validation acceptable to FDA GCP/GLP/GMP, NAMAS, and EN45001 standards both cost effectively and efficiently. The templates included supply documentation examples and the checklists assure readers that all aspects of their validation are covered in logical sequence.