InTouch
March / April 2017

Over of NEW ISPE GAMP® Good Practice Guide: Global Info Systems Control & Compliance

Article - ISPE Pharmaceutical Engineering

ISPE GAMP® Good Practice Guide: Global Information Systems Control and Compliance (Second Edition)

The ISPE GAMP® Good Practice Guide: Global Information Systems Control and Compliance (Second Edition) covers major issues related to multisite computerized systems, and provides guidance on effective and efficient control, and compliance of globally deployed IT systems throughout their life cycle.

In particular, this guide aims to assist in the following aspects of widely used, regulated, global information systems:

  • Development
  • Management
  • Validation
  • Implementation
  • Maintenance
ISPE GAMP® Good Practice Guide: Global Information Systems Control and Compliance (Second Edition)

This revised guide is intended to be used in conjunction with ISPE GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems and other ISPE GAMP® guidance documents. Item reflects changes in typical system architecture since the First Edition, and also covers Software as a Service (SaaS) and other cloud solutions.

Thank you to all guide contributors:

Winnie Cappucci, Bayer Healthcare (retired), US Chris Clark, TenTenTen Consulting, United Kingdom Gail Evans, Technical Writer/Editor, United Kingdom Colin Jones, Conformity Limited, United Kingdom David Stokes, Convalido Consulting Limited, United Kingdom Randy Perez (Lead), Novartis (retired), US Lorrie Vuolo-Schuessler, GlaxoSmithKline, US Christopher White, Alexion Pharmaceuticals, US Sion Wyn, Conformity Limited, United Kingdom