21 Cfr Part 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry

ISBN-13: 9780849322433 / Angielski / Twarda / 2004 / 244 str.

Orlando Lopez; Josefa Lopez Lopez

Opis

Covering regulatory requirements stipulated by the FDA, this book delineates the organization, planning, verification, and documentation activities and procedural controls required for compliance.

Spis treści

Covering regulatory requirements stipulated by the FDA, this book delineates the organization, planning, verification, and documentation activities and procedural controls required for compliance. The author introduces appropriate 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. The material is presented through practical applications of quality assurance and engineering techniques as they relate to the development of systems fit to meet user and regulatory requirements.

O autorze

López, Orlando