Handbook of Computer and Computerized System Validation for the Pharmaceutical Industry

Handbook of Computer and Computerized System Validation for the Pharmaceutical Industry
Author: Stephen Robert Goldman
Publisher: 1st Book Library
Total Pages: 480
Release: 2003
Genre: Business & Economics
ISBN:

Download Handbook of Computer and Computerized System Validation for the Pharmaceutical Industry Book in PDF, Epub and Kindle

This handbook details methods for sustainable compliance with GxPs and 21 CFR Part 11 validation requirements regarding computerized systems in the pharmaceutical, biotechnology, and medical device industry. The handbook follows FDA guidelines and best industry practices in defining roles, responsib


Handbook of Computer and Computerized System Validation for the Pharmaceutical Industry
Language: en
Pages: 480
Authors: Stephen Robert Goldman
Categories: Business & Economics
Type: BOOK - Published: 2003 - Publisher: 1st Book Library

GET EBOOK

This handbook details methods for sustainable compliance with GxPs and 21 CFR Part 11 validation requirements regarding computerized systems in the pharmaceutic
Pharmaceutical Computer Systems Validation
Language: en
Pages: 773
Authors: Guy Wingate
Categories: Medical
Type: BOOK - Published: 2016-04-19 - Publisher: CRC Press

GET EBOOK

Thoroughly revised to include the latest industry developments, the Second Edition presents a comprehensive overview of computer validation and verification pri
21 CFR Part 11
Language: en
Pages: 287
Authors: Orlando López
Categories: Medical
Type: BOOK - Published: 2004-01-15 - Publisher: CRC Press

GET EBOOK

Covering regulatory requirements stipulated by the FDA, this book delineates the organization, planning, verification, and documentation activities and procedur
Computer Systems Validation
Language: en
Pages: 1032
Authors: Guy Wingate
Categories: Medical
Type: BOOK - Published: 2003-12-18 - Publisher: CRC Press

GET EBOOK

Both pervasive and ubiquitous, computerized systems are now an integral component of every corporate strategy in pharmaceutical and healthcare companies. Howeve
Pharmaceutical Computer Validation Introduction Guidebook
Language: en
Pages: 116
Authors: Daniel Farb
Categories: Medical
Type: BOOK - Published: 2005 - Publisher: UniversityOfHealthCare

GET EBOOK

Pharmaceutical Computer Validation Introduction gives you a comprehensive introduction to computer systems validation as the computers come to life while the he