Current regulations expect that all users are appropriately trained and that must include being trained how to effectively perform UAT.
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.
Areas to be Covered:
The validation process and where users fit in
The importance of documentation
User Acceptance Testing (UAT)
Writing UAT Scripts
Running UAT Scripts
Who will Benefit:
Clinical Research Professionals
Anyone who interfaces with a validated clinical system