ISBN: 9780849318719 - computer systems validation: quality assurance, risk management, and regulatory compliance for pharmaceutical and healthcare companies (9 risultati)

Gebunden. Condizione: New. Guy WingateBoth pervasive and ubiquitous, computerized systems are now an integral component of every corporate strategy in pharmaceutical and healthcare companies. However, when technology is combined with high-risk public safety projects or the pro.

Condizione: New.

Condizione: As New. Unread book in perfect condition.

Condizione: As New. Unread book in perfect condition.

Condizione: New.

Buch. Condizione: Neu. Neuware - The most comprehensive guide to computer validation currently available, this invaluable reference discusses good laboratory, clinical, manufacturing, and distribution practices and explains the latest regulatory developments for the US, European and other regulatory authorities. Practical examples and checklists appear throughout the book and the authors explores the role of quality assurance and risk management as key components of pragmatic regulatory compliance. He reviews over twenty case studies of different types of computer systems. Latest FDA and PIC/S developments concerning computer validation, electronic records and signatures, and process analytical technologies are included.…

Condizione: New. pp. 1032 1st Edition.

Condizione: New. pp. 1032.

Condizione: New. pp. 1032 Illus. This item is printed on demand.