Digital Validation Systems & Automation (Industry 4.0 for FDA-Regulated Environments)
Best Practices for Testing, IQ/OQ/PQ and Regression in CSV Projects
Best Practices for Testing, IQ/OQ/PQ and Regression in CSV Projects Best Practices for Testing, IQ/OQ/PQ and Regression in CSV Projects Computerized System Validation (CSV) has become a pivotal process in ensuring that systems and processes in FDA-regulated environments meet the stringent requirements established for compliance. This tutorial provides a comprehensive guide on the best practices for Testing, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Regression Testing in CSV projects, focusing primarily on the requirements outlined in 21 CFR Part 11. Understanding the Fundamentals of Computerized System Validation The primary objective of CSV is to assure stakeholders that…