EU Annex 11 guide to computer validation compliance for the Worldwide Health Agency GMP / Orlando López ; contributors, R.D. McDowall [and three others].
Publication Info.
Boca Raton, FL : CRC Press is an imprint of the Taylor & Francis Group, an informa business, [2015]
Online resource; title from title screen (Books24x7.com, viewed July 21, 2015).
Summary
The purpose of Annex 11 is to provide the EMA healthcare industry with consistent criteria for effective implementation, control, and use of computer systems. This book supplies practical information to facilitate compliance with computer system