Computer System Validation and User Acceptance Testing

Duration: 90 Minutes
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.
Regulatory Requirements for CSV and UAT
Instructor: Jane Tucker
Product ID: 501285
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
  • Programmers
  • Data Managers
  • Statisticians
  • CRAs
  • Monitors
  • Clinical Trial Administrators
$375
Recorded Session for one participant
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How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Over the past 30+ years Jane has moved from routine data cleaning activities, via system validation on to training and data quality activities, eventually specializing, within her role as a Quality Risk Manager, in Risk Assessment and Management. Jane's Risk Assessment and Management expertise covered a range of areas from the R&D Management team, through individual departments and then clinical trial teams and process improvement projects, not forgetting software development projects, large and small. Over that period of time Jane has worked for a number of major Pharmaceutical companies and CROs, before retiring from one of the top pharmaceutical companies.

Jane has also been involved as a contributory author to a number of System Validation guidelines รข?? Computer Systems Validation, A Practical Guide 1998; Computerized Systems Validation in Clinical Research, A practical guide 2004 and most recently Validation and Management of e-Clinical Systems in Collaborative Clinical Trials 2015.

Jane now operates as a Risk Management Trainer and consultant, specializing in Study Level Risk Management and Risk-based Monitoring as well as facilitation of risk assessment workshops.
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