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.
By:
Orlando López
Imprint: CRC Press
Country of Publication: United Kingdom
Dimensions:
Height: 254mm,
Width: 178mm,
Weight: 453g
ISBN: 9780367394592
ISBN 10: 0367394596
Pages: 260
Publication Date: 23 September 2019
Audience:
Professional and scholarly
,
Undergraduate
Format: Paperback
Publisher's Status: Active
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.
