CSV vs CSA for Medical Devices: Building Compliance with Data Integrity and FDA Guidance
In the rapidly evolving life sciences and medical device industry, regulatory compliance is not just a requirement—it’s a commitment to patient safety, product quality, and global trust. Two critical frameworks dominate software validation and assurance: Computer System Validation (CSV) and Computer Software Assurance (CSA) . Understanding the difference between CSV and CSA, their impact on medical devices, and their alignment with FDA remediation strategies is vital for organizations aiming to stay compliant and competitive. At Compliance Gurus, we specialize in guiding companies through this transition, helping them build data integrity programs and assessments, apply ALCOA+ principles in software validation, and adopt a future-ready approach to regulatory compliance. CSV vs CSA for Medical Devices : The Big Shift Traditionally, CSV (Computer System Validation) has been the gold standard for validating software systems used in medical devices and regulated environment...