Singapore Seminar on FDA Data Integrity for Computerized Systems 2017

Overview: The Problem: We have all heard of Data Integrity but do you really understand what it is? Do you understand how 21 CFR 11 and Annex 11 fit into this picture? Specifically, can you answer questions on the following? • Evolution of 21 CFR Part 11 and Annex 11 and Why they are Back in the News • Overview and Key Requirements of Part 11 & Annex 11 • How to use a Risk Based Assessment to reduce work while still achieving Data Integrity and Compliance? • How FDA & other Regulatory Authorities Inspect Computerized Systems for Data Integrity? I often refer to 21 CFR 11 and Annex 11 as Good Software Engineering with the Documentation on Steroids!