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 ...
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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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Add this copy of 21 Cfr Part 11: Complete Guide to International to cart. $75.69, very good condition, Sold by Goodbookscafe rated 5.0 out of 5 stars, ships from Macon, GA, UNITED STATES, published 2004 by CRC Press.
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Some corner dings. The cover shows normal wear and tear. This book is in VERY GOOD condition. The cover and spine are solid, with minimal wear associated with shelved books. The interior pages are excellent, with no markings or highlighting. Page edges should be clean. No additional materials such as disks or codes are included, unless otherwise stated. Fast Shipping-Safe and Secure Bubble Mailer!
Add this copy of 21 Cfr Part 11: Complete Guide to International to cart. $75.69, very good condition, Sold by ThriftBooks-Dallas rated 4.0 out of 5 stars, ships from Dallas, TX, UNITED STATES, published 2004 by CRC Press.
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