EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP
Orlando LopezThis book provides practical information to enable compliance with computer system validation requirements, while highlighting and integrating the Annex 11 guidelines into the computer validation program. The ideas presented in the book are based the author’s experience in the US Department of Defense and regulated industries in various computer systems development, maintenance, and quality functions. A practical approach is presented to increase efficiency and to ensure that software development and maintenance is achieved correctly.
Thể loại:
Năm:
2015
Nhà xuát bản:
CRC Press
Ngôn ngữ:
english
Trang:
280
ISBN 10:
1482243628
ISBN 13:
9781482243628
File:
PDF, 4.52 MB
IPFS:
,
english, 2015