Effective and Practical use of FMEA For Risk-Based Approach to Computer Systems Validation
July 17, 2018 - Online Event ON CAWebinar Compliance
info@webinarcompliance.com
Phone:416-915-4438/ 58
Validation of computer systems is a regulatory requirement within the life sciences. “How much to validate” is one of the biggest challenges validation teams face. The struggle to balance time and available resources with compliance requirements often leads to insufficient testing and/or project overruns, which in turn can lead to significant regulatory and safety risks. One way to avoid these issues is to employ a common risk-prevention tool called Failure Mode and Effects Analysis (FMEA). FMEA will help you focus on your most significant risks, allowing you to more efficiently and effectively validate your computer systems.