Orlando López

21 CFR Part 11

Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry

• Broschiertes Buch

Produktbeschreibung

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

---

Hinweis: Dieser Artikel kann nur an eine deutsche Lieferadresse ausgeliefert werden.

Produktdetails

• Verlag: Taylor & Francis Ltd (Sales)
• Seitenzahl: 260
• Erscheinungstermin: 23. September 2019
• Englisch
• Abmessung: 251mm x 175mm x 15mm
• Gewicht: 431g
• ISBN-13: 9780367394592
• ISBN-10: 0367394596
• Artikelnr.: 57816175

Autorenporträt

López, Orlando

Inhaltsangabe

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.