The Master Validation Plan provides a roadmap to management for on-time start-up of facility operations, and validation of existing facilities, in compliance with GMP requirements. The lack of a... This description may be from another edition of this product.
I have reviewed this excellent book. This book guides you through all process required for validation from FDA. In new edition, the author should give more details and technical guidance for control systems and software validation. Also to help in 21 CFR 11 approval. CD-ROM with the book is a help to cut down all the time wasted in formatting information and make templtes for crtical forms. Congratulations for writing this exceelent book.
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