CSA and Data Integrity: Assuring ALCOA+

Now’s your chance to bridge the gap between Data Integrity and Computer Software Assurance (CSA) by moving beyond traditional, documentation-heavy validation to explore a more right-sized approach. By learning to identify critical GxP functions through their impact on ALCOA+ principles, you’ll be able to determine the areas of regulation that most affect your company.  

This course provides a comprehensive understanding of the Data Governance Framework (21 CFR Part 11 and Annex 11) and the many compliance frameworks that shape the flexibility of the CSA approach. Through the use of interactive scenarios and comprehensive case studies to demonstrate the value of Quality Risk Management (QRM), you’ll gain a strong appreciation of the efficiency of CSA.  Additionally, you will learn how to apply the Segregation of Duties principle and the various compliance foundations upon which to develop and support their approach to CSA.

Join us as we design and build assurance efforts focused on exactly where they matter most: data integrity, product quality, and patient safety.