Computer System Validation and User Acceptance Testing | March 24, 2016 10:00 AM - March 24, 2016 1:00 PM |

Computer System Validation and User Acceptance Testing

Event Summary

March 24, 2016
March 24, 2016 10:00 AM
March 24, 2016 1:00 PM
Online Compliance Panel
[email protected]
Click here to Visit


This course provides an understanding of computerized system validation process and the important role of Users in that process by way of User Acceptance Testing.

From 1997 when ICH GCP section 5.5.3 detailed the need for all computerized systems to be validated and the subsequent release of 21 CFR Part 11, all clinical research personnel need an understanding of computer system validation (CSV). With the increasing use of protocol specific data capture programs and devices eg. ePRO etc., this need CSV understanding has moved from just IT departments and system developers, to all the members of a clinical trial team who need to demonstrate that, within their trial, those devices are 'fit for purpose'. Being 'fit for purpose' cannot be achieved without effective User Acceptance Testing (UAT).

Objectives of the Presentation
By the end of this course you will be able to:
Discuss how big computer system validation is in reality
Review the regulatory background and associated definitions
Explain the validation process
Create good quality documentation suitable for audits and inspections
Input to creation of User Requirements needed for UAT
Create UAT scripts from User Requirements
Run UAT scripts and capture the necessary documentation
Contribute to the maintenance of the validated state of all the clinical computerized systems with which you interact

Why Should you Attend
Any clinical research professional embarking on work that will involve using any computerized system would benefit from attending this course. In order for all the numerous computerized systems used across Clinical Research to maintain their validated state all professionals must have an understanding of the principles of CSV. The achieving, and maintenance, of the validated state will rely on representatives of every 'User Community' i.e. monitors, CRAs, statisticians, data managers, clinical trial assistants etc., being able to step up and perform effective UAT for any or all of the computerized systems with which they interact in their day-to-day activities.

Areas Covered
How big is computer system validation?
Regulatory background and useful definitions
The validation process and where users fit in
The importance of documentation
Writing User requirements
Creating UAT Scripts
Running UAT Scripts and performing regression testing
Maintaining the validated state

Who can Benefit
Data Managers
Clinical Trial Administrators

For Registration

Note: Use Promo code SMMSE and get 10% off on registration (Valid till March 31st)


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