This Book is in Good Condition. Clean Copy With Light Amount of Wear. 100% Guaranteed. Summary: Introduction. Validation Overview. USA Regulatory Requirements for Computer Systems. New Computer Systems Validation Model. Computer Validation Management Cycle. Computer Validation Program Organization. The Computer Systems Validation Process. Validation Project Plans and Schedules. Inspections and Testing. Qualifications. SLC Documentation. Relevant Procedural Controls. Change Management. Training. Security. Source Code. All Together. The Future. Appendices. Buchnummer des Verkäufers
Inhaltsangabe: 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.
Buchbeschreibung Buchzustand: New. Our Ranking is Your Confidence! This is a brand new book! Fast Shipping - Safe and Secure Mailer - Our goal is to deliver a better item than what you are hoping for! If not we will make it right!. Buchnummer des Verkäufers 1XGDJP00184Z
Buchbeschreibung CRC Press, 2016. Hardback. Buchzustand: 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 15 working days. Buchnummer des Verkäufers HTANDREE0248763
Buchbeschreibung Informa Healthcare, 2004. Hardcover. Buchzustand: Brand New. 1st edition. 264 pages. 9.75x7.50x0.75 inches. In Stock. Buchnummer des Verkäufers __084932243X
Buchbeschreibung Informa Healthcare 2004-01-15, 2004. Hardcover. Buchzustand: New. 1. 084932243X. Buchnummer des Verkäufers 532878
Buchbeschreibung CRC Press, 2004. Hardcover. Buchzustand: New. book. Buchnummer des Verkäufers 084932243X