Risk Based approach in CSV

When we consider validating a Computer System what comes to your mind? Tons of documentation? Cumbersome? Tedious? Time-consuming? Challenging? May be Non Value Added? If some of these words are true for your organisation you’re not alone. The FDA is most interested in situations that could directly impact product safety or quality - high-risk events. A long time ago the world of standards has moved towards a risk-based approach.
In today’s webinar Sara Levy will explain how to implement a sound Risk Management Programme while validating a Computer system ; how One of the main parameters to implement a sound risk management program is to have a good understanding of the organization’s critical data assets. And how organisations would be in a better position to allocate their resources based on the criticality of the process and system generating critical data assets ; and finally how ONLY a risk-based approach leads to the best results and compliance with FDA’s expectations.
Sara has a B.Sc. in Industrial and Management Engineering with more than 25 years of experience in the field of Information Systems and Quality Assurance. She is highly proficient in Computerised Systems Validation, Data Governance and Data Integrity in compliance with applicable regulations such as Part 11, Part 820, ISO Standards, such as ISO 13485 and MHRA Guidelines. Sara has an international background having lived in Venezuela, USA, Canada, and currently in Israel.