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
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