M00001417
New product
ISPE GAMP Good Practice Guide: Global Information Systems Control and Compliance
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 11/01/2005
The GAMP Good Practice Guide: Global Information Systems Control and Compliance considers major issues that confront companies validating a multi-site computerized system. This Guide aims to assist in the efficient and effective development, implementation, and maintenance of these systems and addresses compliance with international pharmaceutical regulations and guidelines. It covers:
new systems and extensions to existing onesexisting validated systems to be maintained The main body of the GAMP Good Practice Guide: Global Information Systems Control and Compliance is divided into four main sections:
Project Management Validation and Implementation Global Systems Management Data Management The appendices provide additional material and guidance to assist in the identification of regulations, issues, and topics that should be considered.
References are provided to supporting information available in other GAMP guidance. This Guide is intended as a supplement to GAMP 4, and provides more specific detail where additional information is not already available in GAMP 4. Product Details
Published: 11/01/2005 ISBN(s): 1931879435 Number of Pages: 92
In stock
Warning: Last items in stock!
Availability date: 03/29/2022