Covering regulatory requirements stipulated by the FDA, this book delineates the organization, planning, verification, and documentation activities and procedural controls required for compliance with worldwide computer systems validation regulations. The author introduces supporting technologies such as encryption and digital signatures and places regulatory compliance within the context of quality assurance. He demonstrates the importance of integrating validation activities into the system lifecycle using a structured top-down approach. He covers practical applications of quality assurance and engineering techniques as they relate to the development of systems fit to meet user and regulatory requirements.
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Book Description CRC Press, 2017. Hardback. Book Condition: NEW. 9780849322433 This listing is a new book, a title currently in-print which we order directly and immediately from the publisher. Print on Demand title, produced to the highest standard, and there would be a delay in dispatch of around 10 working days. For all enquiries, please contact Herb Tandree Philosophy Books directly - customer service is our primary goal. Bookseller Inventory # HTANDREE0248763
Book Description Informa Healthcare, 2004. Hardcover. Book Condition: Brand New. 1st edition. 264 pages. 9.75x7.50x0.75 inches. In Stock. Bookseller Inventory # __084932243X
Book Description CRC Press, 2004. Hardcover. Book Condition: New. Never used!. Bookseller Inventory # P11084932243X
Book Description CRC Press. Hardcover. Book Condition: New. 084932243X New Condition. Bookseller Inventory # NEW7.1844707