What comes to mind when we think about validating a computer system? Tons of documentation? Cumbersome? Boring? Time-consuming? Challenging? Perhaps no added value? If some of these words apply to your company, you are not alone. FDA is most interested in situations that could directly affect product safety or quality – high-risk events. Long ago, the standards world moved toward a risk-based approach.
In today's webinar, Sara Levy explains how to implement a sound risk management program when validating a computer system. One of the most important parameters for implementing a sound risk management program is a good understanding of the organization's critical data assets. And how organizations can better allocate their resources according to the criticality of the process and system that generates critical data assets. And finally, how ONLY a risk-based approach will lead to the best results and compliance with FDA expectations.
Sara holds a B.Sc. in Industrial Engineering and Management with over 25 years of experience in the field of Information Systems and Quality Assurance. She has extensive knowledge in computerized systems validation, data management and data integrity according to applicable regulations such as Part 11, Part 820, ISO standards such as ISO 13485 and MHRA guidelines. Sara has an international background and has lived in Venezuela, USA, Canada and currently in Israel.

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