21 CFR Part 11 : complete guide to international computer validation compliance for the pharmaceutical industry /: complete guide to international computer validation compliance for the pharmaceutical industry. (©2004)

• Record Type: Book
• Other Titles: Twenty-one CFR Part Eleven
• Further Information: Note: Orlando López.
• Other Names: López, Orlando
• Contents: 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
• Publisher Details: Boca Raton : Interpharm/CRC Sue Horwood Pub
• Publication Date: 2004
• Copyright Date: 2004
• Extent: 1 online resource (xv, 243 pages), illustrations
• Subjects: 338.4/76151; Pharmaceutical industry; Computer software -- Validation; Computer programs -- Verification; BUSINESS & ECONOMICS -- Industries -- Pharmaceutical & Biotechnology; Computer programs -- Verification; Computer software -- Validation; Pharmaceutical industry; Electronic books
• Languages: English
• ISBNs: 0203026772; 9780203026779
• Related ISBNs: 084932243X
• Notes: Note: Includes bibliographical references and index.; Note: Print version record.
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.