Associate Director, Computer Systems Validation
Alkermes
Are You Aligned with FDA's Computer Software Assurance Methodology?
If you’re following these 3 core principles, odds are you’re already aligned with the FDA's computer software assurance (CSA) methodology.
Leveraging Vendor Testing: A Smarter Approach to Validation
Learn how to reduce costs, improve accuracy, and enhance compliance by integrating vendor-provided testing into your validation framework.
Rethinking Validation: Why CSV Falls Short for Agile Teams
Learn how traditional CSV conflicts with Agile development principles and why computer software assurance (CSA) is a better fit for Agile environments.