Written by experts, this book provides authoritative information and practical advice on validating corporate computer systems. It covers good it practice and validation principles and presents case studies on edmss, eam systems, limbs and MRP II systems. Topics include the increasing role of it systems within the modern pharmaceutical manufacturing plant and the move toward Paper less manufacturing, how to develop an information strategy, the importance of demonstrating regulatory compliance, how to maintain validated systems, conduct supplier audits for software packages, hardware manufacturers and software integrators, the practical