CSV vs CSA for Medical Devices: A Comprehensive Guide to Compliance and Data Integrity

Tue, 09 Sep 2025 15:12:28 +0000

As the medical device industry evolves, so does the regulatory landscape. Companies face increasing scrutiny from regulatory bodies like the FDA, which demands robust compliance and data integrity programs to ensure patient safety and product efficacy. Two critical terms often discussed in this realm are CSV (Computer System Validation) and CSA (Computer Software Assurance). This blog post by Compliance Gurus dives deep into the distinctions between CSV and CSA, explores data integrity programs and assessments, and highlights key concepts like FDA remediation and ALCOA+ principles in software validation. Understanding these aspects is crucial for any medical device manufacturer or software developer navigating FDA regulations in 2025 and beyond.