This course provides an understanding of the role of users in system validation and covers good documentation practice and the writing of UAT scripts. It then moves on to running UAT scripts and the need for accurate reporting their results plus the implications when a stage in a UAT script fails and program changes are necessary. ICH GCP and 21 CFR Part 11 both expect that all computerized systems in clinical research should be validated, and the implementation of such computerized systems is growing exponentially. The process of establishing a computerized system is dependent upon one pivotal role – the User. The role of the User especially with regard to the User Acceptance Testing (UAT) is essential, but if users are not trained in all the areas that they need to be aware of when performing UAT the final system when implemented may not be as effective as it could have been.
Mississauga, Ontario 44813, Canada
Phone: 4169154458
If you'd like to ask a question or post a comment about this talk please do so below.
This seminar posting is brought to you by Biotechnology Calendar, Inc. providing access to research information and research tools for nearly 20 years. Visit our Science Market Update Blog for current science funding and market information or see our schedule of upcoming science research laboratory product shows.