ISPE 4GIS

$49.00

ISPE GAMP Good Practice Guide: Global Information Systems Control and ComplianceInternational Society for Pharmaceutical Engineering / 2005 / 92 pages ISBN: 1931879435

For processes that are conducted at multiple sites, there are clearly advantages to all participants using the same suite of software systems. The implementation of these multi-site computer systems can be very difficult, and for regulated systems, validation issues add an extra layer of complication. 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.




Add to Cart:

  • Model: FXEK49P0
  • 8888 Units in Stock


This product was added to our catalog on Thursday 01 January, 1970.

Your IP Address is: 54.224.166.141
Copyright © 2018 Buy Standards.