Over of NEW ISPE GAMP® Good Practice Guide: Global Info Systems Control & Compliance
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:
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
GROWTH IN ATTENDANCE AT THE ISPE EUROPE ANNUAL CONFERENCE 2017–2019
HEALTH APPS AROUND THE WORLD 1
200 new apps added per day
Over 318,000 available worldwide
ISPE launched its complimentary Pharma Best Practices Webinar Series in April. The debut was outstanding, drawing more than 850 registrants and over 500 real-time participants representing 62 countries and six regulatory agencies from around the world.
Delaware Valley Chapter Executive Vice President Eleanor Small, 34, is a woman with a passion for science and technology. Although still early in her career, she has already accomplished a lot, including being awarded the prestigious Delaware Valley Young Engineer of the Year award for 2019.