Computer System Validation



This course provides a background to CSV regulations and guidance on the overall process of validation and the importance of good documentation.

Computer System Validation is a regulatory requirement under ICH GCP and 21 CFR Part 11 but it also makes good business sense to ensure that computerized systems will perform consistently as expected. Validation of Computerized Systems has a very specific set of tasks that are often mismanaged, resulting in missed deadlines, increased costs, and regulatory risk, and missed times to market for a company’s product. Achieving the validated state requires much more than just User Acceptance Testing. This detailed webinar will explain the basic tenets of of 21 CFR 11 compliance for Computer Systems Validation and will show how to deliver on time and on budget while meeting regulatory compliance requirements in a more effective manner.

Areas to be Covered:

How big is computer system validation?
Regulatory background and useful definitions
The validation process
The importance of documentation
User Acceptance Testing (UAT)
Maintaining the validated state

Who will Benefit:

This webinar is a must for:
Regulatory Affairs Staff
Data Managers
Clinical Affairs Staff
Clinical Research Professionals
Any company that uses a computerized system to give input to new systems specifications and/or User Acceptance Testing

Jane Tucker

Jane Tucker :
Over the past 28 years Jane has moved from routine data cleaning activities, via computer system validation onto training and data quality activities, eventually specializing in Quality Risk Management. Jane has worked for a variety of large pharmaceutical companies and CROs before retiring from GlaxoSmithKline. 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.

Sue Fitzpatrick :
Sue Fitzpatrick joined the Pharmaceutical Industry in 1980. She has been responsible for the management and audit of CRAs and clinical trials in a wide range of therapeutic areas. As former Head of Education and Training at the Institute of Clinical Research she was responsible for the provision of training courses for the industry and postgraduate courses in collaboration with several UK Universities.

Sue continues her collaborations and is an accredited teacher with Cranfield University. Sue is currently a Director of Redtree people working on employability skills to help new entrants enter the sector. She has authored many articles and books on clinical research and career development topics. Sue is currently working on a book in Clinical and Healthcare Research for publication with the Oxford University Press.


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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance