December 3rd, 2020 | 58:12

How Will FDA’s New Approach to CSV Make Implementations Easier?

There is a big shift in the computer system validation (CSV) strategy coming from the FDA. The new methodology and guidance called Computer System Assurance (CSA) is still expected within 2020. Its focus is taking the principles from Quality Risk Management and applying that same logic to computer systems. In this webinar, we will dissect the new CSA approach and explore the key matrices/tools needed to make solid risk determinations thus providing the framework needed to streamline computer platform implementations and on-going maintenance.

In the final analysis, there are key questions that must be applied for CSA to be effective. Does the software impact patient safety? Does this software impact product quality? How does this software impact your quality system integrity?

Learn in this Webinar:

  • What is Computer Software Assurance for Manufacturing, Operations and Quality Systems Software?
  • Understand the differences between CSA and CSV model.
  • When do I need to be prepared for the new approach and final guidance / regulations?

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