Basic Principles of Computerized Systems Compliance Using GAMP® 5 Version 2 - EU edition MasterClass

With modern facilities, installations, and equipment, PLCs and computers are an integral part of such systems. More often than not PLCs and computers are considered autonomous systems and handled separately within the QMS and protocols. In this two-day course, we will look at Basic Principles of Computerized Systems Compliance using ISPE’s GAMP5 Version 2 industry guidelines, compared to FDA’s Title 21 CRF Part 11 regulations, and EU’s Eudralex Volume 4 Annex 11 guidelines.